Pancreas and Biliary Tract

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

Early, aggressive fluid resuscitation in acute pancreatitis led to a higher incidence of fluid overload without improving clinical outcomes in the landmark WATERFALL trial.

Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited.

“The WATERFALL trial demonstrates that aggressive fluid resuscitation in acute pancreatitis is not safe, it is not associated with improved outcomes, and it should be abandoned,” Enrique de-Madaria, MD, PhD, with Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization.

iStock/ThinkStock

The trial settles a “new and clear reference for fluid resuscitation in this frequent disease: lactated Ringer’s solution 1.5 mL/kg per hour (preceded by a 10 mL/kg bolus over 2 hours only in case of hypovolemia),” added Dr. de-Madaria, president of the Spanish Association of Gastroenterology.

“This moderate fluid resuscitation strategy is associated with a much lower frequency of fluid overload and a trend toward improved outcomes. For such reasons, it should be considered as a new standard of care in the early management of acute pancreatitis,” Dr. de-Madaria said.

The WATERFALL trial results were published in the New England Journal of Medicine.

The results are “stunning and, given the carefully crafted trial methods, irrefutable,” Timothy Gardner, MD, with the section of gastroenterology and hepatology, Dartmouth–Hitchcock Medical Center, Lebanon, N.H., wrote in a linked editorial.
 

Trial details

The trial was conducted at 18 centers across India, Italy, Mexico, and Spain. Patients who presented with acute pancreatitis were randomly allocated to aggressive or moderate resuscitation with lactated Ringer’s solution.

Aggressive fluid resuscitation consisted of a bolus of 20 mL/kg of body weight, followed by 3 mL/kg per hour. Moderate fluid resuscitation consisted of a bolus of 10 mL/kg in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 mL/kg per hour in all patients in this group.

Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to clinical status.

A total of 249 patients were included in the interim analysis – 122 in the aggressive-resuscitation group and 127 in the moderate-resuscitation group.

The data and safety monitoring board terminated the trial at the first interim safety analysis as a result of the development of fluid overload in 20.5% of the patients in the aggressive-resuscitation group versus 6.3% of those in the moderate-resuscitation group (adjusted relative risk, 2.85; 95% confidence interval, 1.36-5.94; P = .004).

“An increased risk of fluid overload was detected in the overall population of patients and also in subgroups of patients without systemic inflammatory response syndrome at baseline, patients with SIRS at baseline (thus, with a higher risk of development of severe pancreatitis), and patients with hypovolemia,” the investigators reported.

This clear signal of harm was coupled with no significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; aRR, 1.30; 95% CI, 0.78-2.18; P = .32).

Patients in the aggressive-resuscitation group spent a median of 6 days in the hospital, compared with 5 days for patients in the moderate-resuscitation group.

“These findings do not support current management guidelines, which recommend early aggressive resuscitation for the treatment of acute pancreatitis,” the study team wrote.
 

‘Landmark’ trial

This is a “landmark” trial and “so clinically relevant because of its choice of real world-appropriate aggressive-resuscitation and moderate-resuscitation treatment groups, its use of pancreatitis severity as the main clinical outcome, and its reliance on the carefully defined variable of fluid overload as the main safety outcome,” Dr. Gardner wrote in his editorial.

“Unlike in most other randomized, controlled trials of fluid resuscitation in acute pancreatitis, patients with varying baseline pancreatitis severity were included, and changes in the rate of resuscitation were determined on the basis of a dynamic assessment of hemodynamic testing, imaging, and clinical factors,” he added.

Dr. Gardner said the WATERFALL trial results lead to several conclusions.

First, the need to focus on a steady rate of initial resuscitation – no more than 1.5 mL/kg of body weight per hour. Clinicians should administer a bolus of 10 mL/kg only if there are signs of initial hypovolemia.

Second, that careful clinical and hemodynamic monitoring are essential during the first 72 hours after admission to make sure that patients remain euvolemic and to avoid fluid overload.

Third, that diuresis in patients with fluid overload in the first 72 hours is most likely beneficial and certainly not detrimental to important clinical outcomes.

Dr. Gardner said the trial also highlights the need to focus research efforts on evaluating other pharmacologic therapies instead of crystalloid fluids.

“Performing randomized controlled trials in acute pancreatitis is notoriously difficult, and the limited human and financial resources that are available for appropriately powered trials in this field post WATERFALL are much better spent on comparative-effectiveness and placebo-controlled trials evaluating new therapeutic agents,” Dr. Gardner said.

“Now that we have gone over the WATERFALL, it is time to look downstream at new targets to treat this challenging disease,” he concluded.

Support for the trial was provided by Instituto de Salud Carlos III, the Spanish Association of Gastroenterology, and ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante).

A version of this article first appeared on Medscape.com.

Early, aggressive fluid resuscitation in acute pancreatitis led to a higher incidence of fluid overload without improving clinical outcomes in the landmark WATERFALL trial.

Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited.

“The WATERFALL trial demonstrates that aggressive fluid resuscitation in acute pancreatitis is not safe, it is not associated with improved outcomes, and it should be abandoned,” Enrique de-Madaria, MD, PhD, with Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization.

iStock/ThinkStock

The trial settles a “new and clear reference for fluid resuscitation in this frequent disease: lactated Ringer’s solution 1.5 mL/kg per hour (preceded by a 10 mL/kg bolus over 2 hours only in case of hypovolemia),” added Dr. de-Madaria, president of the Spanish Association of Gastroenterology.

“This moderate fluid resuscitation strategy is associated with a much lower frequency of fluid overload and a trend toward improved outcomes. For such reasons, it should be considered as a new standard of care in the early management of acute pancreatitis,” Dr. de-Madaria said.

The WATERFALL trial results were published in the New England Journal of Medicine.

The results are “stunning and, given the carefully crafted trial methods, irrefutable,” Timothy Gardner, MD, with the section of gastroenterology and hepatology, Dartmouth–Hitchcock Medical Center, Lebanon, N.H., wrote in a linked editorial.
 

Trial details

The trial was conducted at 18 centers across India, Italy, Mexico, and Spain. Patients who presented with acute pancreatitis were randomly allocated to aggressive or moderate resuscitation with lactated Ringer’s solution.

Aggressive fluid resuscitation consisted of a bolus of 20 mL/kg of body weight, followed by 3 mL/kg per hour. Moderate fluid resuscitation consisted of a bolus of 10 mL/kg in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 mL/kg per hour in all patients in this group.

Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to clinical status.

A total of 249 patients were included in the interim analysis – 122 in the aggressive-resuscitation group and 127 in the moderate-resuscitation group.

The data and safety monitoring board terminated the trial at the first interim safety analysis as a result of the development of fluid overload in 20.5% of the patients in the aggressive-resuscitation group versus 6.3% of those in the moderate-resuscitation group (adjusted relative risk, 2.85; 95% confidence interval, 1.36-5.94; P = .004).

“An increased risk of fluid overload was detected in the overall population of patients and also in subgroups of patients without systemic inflammatory response syndrome at baseline, patients with SIRS at baseline (thus, with a higher risk of development of severe pancreatitis), and patients with hypovolemia,” the investigators reported.

This clear signal of harm was coupled with no significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; aRR, 1.30; 95% CI, 0.78-2.18; P = .32).

Patients in the aggressive-resuscitation group spent a median of 6 days in the hospital, compared with 5 days for patients in the moderate-resuscitation group.

“These findings do not support current management guidelines, which recommend early aggressive resuscitation for the treatment of acute pancreatitis,” the study team wrote.
 

‘Landmark’ trial

This is a “landmark” trial and “so clinically relevant because of its choice of real world-appropriate aggressive-resuscitation and moderate-resuscitation treatment groups, its use of pancreatitis severity as the main clinical outcome, and its reliance on the carefully defined variable of fluid overload as the main safety outcome,” Dr. Gardner wrote in his editorial.

“Unlike in most other randomized, controlled trials of fluid resuscitation in acute pancreatitis, patients with varying baseline pancreatitis severity were included, and changes in the rate of resuscitation were determined on the basis of a dynamic assessment of hemodynamic testing, imaging, and clinical factors,” he added.

Dr. Gardner said the WATERFALL trial results lead to several conclusions.

First, the need to focus on a steady rate of initial resuscitation – no more than 1.5 mL/kg of body weight per hour. Clinicians should administer a bolus of 10 mL/kg only if there are signs of initial hypovolemia.

Second, that careful clinical and hemodynamic monitoring are essential during the first 72 hours after admission to make sure that patients remain euvolemic and to avoid fluid overload.

Third, that diuresis in patients with fluid overload in the first 72 hours is most likely beneficial and certainly not detrimental to important clinical outcomes.

Dr. Gardner said the trial also highlights the need to focus research efforts on evaluating other pharmacologic therapies instead of crystalloid fluids.

“Performing randomized controlled trials in acute pancreatitis is notoriously difficult, and the limited human and financial resources that are available for appropriately powered trials in this field post WATERFALL are much better spent on comparative-effectiveness and placebo-controlled trials evaluating new therapeutic agents,” Dr. Gardner said.

“Now that we have gone over the WATERFALL, it is time to look downstream at new targets to treat this challenging disease,” he concluded.

Support for the trial was provided by Instituto de Salud Carlos III, the Spanish Association of Gastroenterology, and ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante).

A version of this article first appeared on Medscape.com.

Early, aggressive fluid resuscitation in acute pancreatitis led to a higher incidence of fluid overload without improving clinical outcomes in the landmark WATERFALL trial.

Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited.

“The WATERFALL trial demonstrates that aggressive fluid resuscitation in acute pancreatitis is not safe, it is not associated with improved outcomes, and it should be abandoned,” Enrique de-Madaria, MD, PhD, with Hospital General Universitario Dr. Balmis, Alicante, Spain, told this news organization.

iStock/ThinkStock

The trial settles a “new and clear reference for fluid resuscitation in this frequent disease: lactated Ringer’s solution 1.5 mL/kg per hour (preceded by a 10 mL/kg bolus over 2 hours only in case of hypovolemia),” added Dr. de-Madaria, president of the Spanish Association of Gastroenterology.

“This moderate fluid resuscitation strategy is associated with a much lower frequency of fluid overload and a trend toward improved outcomes. For such reasons, it should be considered as a new standard of care in the early management of acute pancreatitis,” Dr. de-Madaria said.

The WATERFALL trial results were published in the New England Journal of Medicine.

The results are “stunning and, given the carefully crafted trial methods, irrefutable,” Timothy Gardner, MD, with the section of gastroenterology and hepatology, Dartmouth–Hitchcock Medical Center, Lebanon, N.H., wrote in a linked editorial.
 

Trial details

The trial was conducted at 18 centers across India, Italy, Mexico, and Spain. Patients who presented with acute pancreatitis were randomly allocated to aggressive or moderate resuscitation with lactated Ringer’s solution.

Aggressive fluid resuscitation consisted of a bolus of 20 mL/kg of body weight, followed by 3 mL/kg per hour. Moderate fluid resuscitation consisted of a bolus of 10 mL/kg in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 mL/kg per hour in all patients in this group.

Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to clinical status.

A total of 249 patients were included in the interim analysis – 122 in the aggressive-resuscitation group and 127 in the moderate-resuscitation group.

The data and safety monitoring board terminated the trial at the first interim safety analysis as a result of the development of fluid overload in 20.5% of the patients in the aggressive-resuscitation group versus 6.3% of those in the moderate-resuscitation group (adjusted relative risk, 2.85; 95% confidence interval, 1.36-5.94; P = .004).

“An increased risk of fluid overload was detected in the overall population of patients and also in subgroups of patients without systemic inflammatory response syndrome at baseline, patients with SIRS at baseline (thus, with a higher risk of development of severe pancreatitis), and patients with hypovolemia,” the investigators reported.

This clear signal of harm was coupled with no significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; aRR, 1.30; 95% CI, 0.78-2.18; P = .32).

Patients in the aggressive-resuscitation group spent a median of 6 days in the hospital, compared with 5 days for patients in the moderate-resuscitation group.

“These findings do not support current management guidelines, which recommend early aggressive resuscitation for the treatment of acute pancreatitis,” the study team wrote.
 

‘Landmark’ trial

This is a “landmark” trial and “so clinically relevant because of its choice of real world-appropriate aggressive-resuscitation and moderate-resuscitation treatment groups, its use of pancreatitis severity as the main clinical outcome, and its reliance on the carefully defined variable of fluid overload as the main safety outcome,” Dr. Gardner wrote in his editorial.

“Unlike in most other randomized, controlled trials of fluid resuscitation in acute pancreatitis, patients with varying baseline pancreatitis severity were included, and changes in the rate of resuscitation were determined on the basis of a dynamic assessment of hemodynamic testing, imaging, and clinical factors,” he added.

Dr. Gardner said the WATERFALL trial results lead to several conclusions.

First, the need to focus on a steady rate of initial resuscitation – no more than 1.5 mL/kg of body weight per hour. Clinicians should administer a bolus of 10 mL/kg only if there are signs of initial hypovolemia.

Second, that careful clinical and hemodynamic monitoring are essential during the first 72 hours after admission to make sure that patients remain euvolemic and to avoid fluid overload.

Third, that diuresis in patients with fluid overload in the first 72 hours is most likely beneficial and certainly not detrimental to important clinical outcomes.

Dr. Gardner said the trial also highlights the need to focus research efforts on evaluating other pharmacologic therapies instead of crystalloid fluids.

“Performing randomized controlled trials in acute pancreatitis is notoriously difficult, and the limited human and financial resources that are available for appropriately powered trials in this field post WATERFALL are much better spent on comparative-effectiveness and placebo-controlled trials evaluating new therapeutic agents,” Dr. Gardner said.

“Now that we have gone over the WATERFALL, it is time to look downstream at new targets to treat this challenging disease,” he concluded.

Support for the trial was provided by Instituto de Salud Carlos III, the Spanish Association of Gastroenterology, and ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante).

A version of this article first appeared on Medscape.com.

Endoscopy plays an integral role in the evaluation and management of patients with recurrent acute pancreatitis and chronic pancreatitis, according to a new American Gastroenterological Association clinical practice update published in Gastroenterology.

Acute pancreatitis remains the leading cause of inpatient care among gastrointestinal conditions, with about 10%-30% of patients developing recurrent acute pancreatitis, wrote co–first authors Daniel Strand, MD, from the University of Virginia Health System, Charlottesville, and Ryan J. Law, MD, from the Mayo Clinic, Rochester, Minn., and colleagues. About 35% of patients with recurrent acute pancreatitis will progress to chronic pancreatitis. Both conditions are associated with significant morbidity and mortality.

“Interventions aimed to better evaluate, mitigate the progression of, and treat symptoms related to [acute pancreatitis] and [chronic pancreatitis] are critical to improve patients’ quality of life and other long-term outcomes,” the authors of the expert review wrote.

The authors reviewed randomized controlled trials, observational studies, systematic reviews and meta-analyses, and expert consensus in the field to develop eight clinical practice advice statements.

First, when the initial evaluation reveals no clear explanation for acute or recurrent pancreatitis, endoscopic ultrasound is the preferred diagnostic test. The authors noted that, although there isn’t a concretely defined optimal timing for EUS defined, most experts advise a short delay of 2-6 weeks after resolution of acute pancreatitis. MRI with contrast and cholangiopancreatography can be a reasonable complementary or alternative test, based on local expertise and availability.

Second, the role of ERCP remains controversial for reducing the frequency of acute pancreatitis episodes in patients with pancreas divisum, the most common congenital pancreatic anomaly, the authors wrote. However, minor papilla endotherapy may be useful, particularly for those with objective signs of outflow obstruction, such as a dilated dorsal pancreatic duct or santorinicele. However, there is no role for ERCP in treating pain alone in patients with pancreas divisum.

Third, ERCP remains even more controversial for reducing the frequency of pancreatitis episodes in patients with unexplained recurrent acute pancreatitis and standard pancreatic ductal anatomy, according to the authors. It should only be considered after a comprehensive discussion of the uncertain benefits and potentially severe procedure-related adverse events. When used, ERCP with biliary sphincterotomy alone may be preferable to dual sphincterotomy.

Fourth, for long-term treatment of patients with painful obstructive chronic pancreatitis, surgical intervention should be considered over endoscopic therapy, the study authors wrote. Pain is the most common symptom and important driver of impaired quality of life in patients with chronic pancreatitis, among whom a subset will be affected by intraductal hypertension from an obstructed pancreatic duct. The authors noted that endoscopic intervention remains a reasonable alternative to surgery for suboptimal operative candidates or patients who want a less-invasive approach, as long as they are clearly informed that the best practice advice primarily favors surgery.

Fifth, when using ERCP for pancreatic duct stones, small main pancreatic duct stones of 5 mm or less can be treated with pancreatography and conventional stone extraction maneuvers. For larger stones, however, extracorporeal shockwave lithotripsy or pancreatoscopy with intraductal lithotripsy can be considered, although the former is not widely available in the United States and the success rates for the latter vary.

Sixth, when using ERCP for pancreatic duct strictures, prolonged stent therapy for 6-12 months is effective for treating symptoms and remodeling main pancreatic duct strictures. The preferred approach is to place and sequentially add multiple plastic stents in parallel, or up-sizing. Emerging evidence suggests that fully covered self-expanding metal stents may be useful in this case, but additional research is needed. For example, one study suggested that patients treated with these self-expanding stents required fewer ERCPs, but their adverse event rate was significantly higher (39% vs. 14%).

Seventh, ERCP with stent insertion is the preferred treatment for benign biliary stricture caused by chronic pancreatitis. Fully covered self-expanding metal stents are favored over placing multiple plastic stents when feasible, given the similar efficacy but significantly lower need for stent exchange procedures during the treatment course.

Eighth, celiac plexus block shouldn’t be routinely performed for the management of pain caused by chronic pancreatitis. Celiac plexus block could be considered in certain patients on a case-by-case basis if they have debilitating pain that hasn’t responded to other therapeutic measures. However, this should only be considered after a discussion about the unclear outcomes and its procedural risks.

“Given the current lack of evidence, additional well-designed prospective comparative studies are needed to support a more unified diagnostic and therapeutic pathway for the treatment of these complex cases,” the authors concluded.

The authors reported no grant support or funding sources for this report. Several authors disclosed financial relationships with companies such as Olympus America, Medtronic, and Microtech.
 

Endoscopy plays an integral role in the evaluation and management of patients with recurrent acute pancreatitis and chronic pancreatitis, according to a new American Gastroenterological Association clinical practice update published in Gastroenterology.

Acute pancreatitis remains the leading cause of inpatient care among gastrointestinal conditions, with about 10%-30% of patients developing recurrent acute pancreatitis, wrote co–first authors Daniel Strand, MD, from the University of Virginia Health System, Charlottesville, and Ryan J. Law, MD, from the Mayo Clinic, Rochester, Minn., and colleagues. About 35% of patients with recurrent acute pancreatitis will progress to chronic pancreatitis. Both conditions are associated with significant morbidity and mortality.

“Interventions aimed to better evaluate, mitigate the progression of, and treat symptoms related to [acute pancreatitis] and [chronic pancreatitis] are critical to improve patients’ quality of life and other long-term outcomes,” the authors of the expert review wrote.

The authors reviewed randomized controlled trials, observational studies, systematic reviews and meta-analyses, and expert consensus in the field to develop eight clinical practice advice statements.

First, when the initial evaluation reveals no clear explanation for acute or recurrent pancreatitis, endoscopic ultrasound is the preferred diagnostic test. The authors noted that, although there isn’t a concretely defined optimal timing for EUS defined, most experts advise a short delay of 2-6 weeks after resolution of acute pancreatitis. MRI with contrast and cholangiopancreatography can be a reasonable complementary or alternative test, based on local expertise and availability.

Second, the role of ERCP remains controversial for reducing the frequency of acute pancreatitis episodes in patients with pancreas divisum, the most common congenital pancreatic anomaly, the authors wrote. However, minor papilla endotherapy may be useful, particularly for those with objective signs of outflow obstruction, such as a dilated dorsal pancreatic duct or santorinicele. However, there is no role for ERCP in treating pain alone in patients with pancreas divisum.

Third, ERCP remains even more controversial for reducing the frequency of pancreatitis episodes in patients with unexplained recurrent acute pancreatitis and standard pancreatic ductal anatomy, according to the authors. It should only be considered after a comprehensive discussion of the uncertain benefits and potentially severe procedure-related adverse events. When used, ERCP with biliary sphincterotomy alone may be preferable to dual sphincterotomy.

Fourth, for long-term treatment of patients with painful obstructive chronic pancreatitis, surgical intervention should be considered over endoscopic therapy, the study authors wrote. Pain is the most common symptom and important driver of impaired quality of life in patients with chronic pancreatitis, among whom a subset will be affected by intraductal hypertension from an obstructed pancreatic duct. The authors noted that endoscopic intervention remains a reasonable alternative to surgery for suboptimal operative candidates or patients who want a less-invasive approach, as long as they are clearly informed that the best practice advice primarily favors surgery.

Fifth, when using ERCP for pancreatic duct stones, small main pancreatic duct stones of 5 mm or less can be treated with pancreatography and conventional stone extraction maneuvers. For larger stones, however, extracorporeal shockwave lithotripsy or pancreatoscopy with intraductal lithotripsy can be considered, although the former is not widely available in the United States and the success rates for the latter vary.

Sixth, when using ERCP for pancreatic duct strictures, prolonged stent therapy for 6-12 months is effective for treating symptoms and remodeling main pancreatic duct strictures. The preferred approach is to place and sequentially add multiple plastic stents in parallel, or up-sizing. Emerging evidence suggests that fully covered self-expanding metal stents may be useful in this case, but additional research is needed. For example, one study suggested that patients treated with these self-expanding stents required fewer ERCPs, but their adverse event rate was significantly higher (39% vs. 14%).

Seventh, ERCP with stent insertion is the preferred treatment for benign biliary stricture caused by chronic pancreatitis. Fully covered self-expanding metal stents are favored over placing multiple plastic stents when feasible, given the similar efficacy but significantly lower need for stent exchange procedures during the treatment course.

Eighth, celiac plexus block shouldn’t be routinely performed for the management of pain caused by chronic pancreatitis. Celiac plexus block could be considered in certain patients on a case-by-case basis if they have debilitating pain that hasn’t responded to other therapeutic measures. However, this should only be considered after a discussion about the unclear outcomes and its procedural risks.

“Given the current lack of evidence, additional well-designed prospective comparative studies are needed to support a more unified diagnostic and therapeutic pathway for the treatment of these complex cases,” the authors concluded.

The authors reported no grant support or funding sources for this report. Several authors disclosed financial relationships with companies such as Olympus America, Medtronic, and Microtech.
 

Endoscopy plays an integral role in the evaluation and management of patients with recurrent acute pancreatitis and chronic pancreatitis, according to a new American Gastroenterological Association clinical practice update published in Gastroenterology.

Acute pancreatitis remains the leading cause of inpatient care among gastrointestinal conditions, with about 10%-30% of patients developing recurrent acute pancreatitis, wrote co–first authors Daniel Strand, MD, from the University of Virginia Health System, Charlottesville, and Ryan J. Law, MD, from the Mayo Clinic, Rochester, Minn., and colleagues. About 35% of patients with recurrent acute pancreatitis will progress to chronic pancreatitis. Both conditions are associated with significant morbidity and mortality.

“Interventions aimed to better evaluate, mitigate the progression of, and treat symptoms related to [acute pancreatitis] and [chronic pancreatitis] are critical to improve patients’ quality of life and other long-term outcomes,” the authors of the expert review wrote.

The authors reviewed randomized controlled trials, observational studies, systematic reviews and meta-analyses, and expert consensus in the field to develop eight clinical practice advice statements.

First, when the initial evaluation reveals no clear explanation for acute or recurrent pancreatitis, endoscopic ultrasound is the preferred diagnostic test. The authors noted that, although there isn’t a concretely defined optimal timing for EUS defined, most experts advise a short delay of 2-6 weeks after resolution of acute pancreatitis. MRI with contrast and cholangiopancreatography can be a reasonable complementary or alternative test, based on local expertise and availability.

Second, the role of ERCP remains controversial for reducing the frequency of acute pancreatitis episodes in patients with pancreas divisum, the most common congenital pancreatic anomaly, the authors wrote. However, minor papilla endotherapy may be useful, particularly for those with objective signs of outflow obstruction, such as a dilated dorsal pancreatic duct or santorinicele. However, there is no role for ERCP in treating pain alone in patients with pancreas divisum.

Third, ERCP remains even more controversial for reducing the frequency of pancreatitis episodes in patients with unexplained recurrent acute pancreatitis and standard pancreatic ductal anatomy, according to the authors. It should only be considered after a comprehensive discussion of the uncertain benefits and potentially severe procedure-related adverse events. When used, ERCP with biliary sphincterotomy alone may be preferable to dual sphincterotomy.

Fourth, for long-term treatment of patients with painful obstructive chronic pancreatitis, surgical intervention should be considered over endoscopic therapy, the study authors wrote. Pain is the most common symptom and important driver of impaired quality of life in patients with chronic pancreatitis, among whom a subset will be affected by intraductal hypertension from an obstructed pancreatic duct. The authors noted that endoscopic intervention remains a reasonable alternative to surgery for suboptimal operative candidates or patients who want a less-invasive approach, as long as they are clearly informed that the best practice advice primarily favors surgery.

Fifth, when using ERCP for pancreatic duct stones, small main pancreatic duct stones of 5 mm or less can be treated with pancreatography and conventional stone extraction maneuvers. For larger stones, however, extracorporeal shockwave lithotripsy or pancreatoscopy with intraductal lithotripsy can be considered, although the former is not widely available in the United States and the success rates for the latter vary.

Sixth, when using ERCP for pancreatic duct strictures, prolonged stent therapy for 6-12 months is effective for treating symptoms and remodeling main pancreatic duct strictures. The preferred approach is to place and sequentially add multiple plastic stents in parallel, or up-sizing. Emerging evidence suggests that fully covered self-expanding metal stents may be useful in this case, but additional research is needed. For example, one study suggested that patients treated with these self-expanding stents required fewer ERCPs, but their adverse event rate was significantly higher (39% vs. 14%).

Seventh, ERCP with stent insertion is the preferred treatment for benign biliary stricture caused by chronic pancreatitis. Fully covered self-expanding metal stents are favored over placing multiple plastic stents when feasible, given the similar efficacy but significantly lower need for stent exchange procedures during the treatment course.

Eighth, celiac plexus block shouldn’t be routinely performed for the management of pain caused by chronic pancreatitis. Celiac plexus block could be considered in certain patients on a case-by-case basis if they have debilitating pain that hasn’t responded to other therapeutic measures. However, this should only be considered after a discussion about the unclear outcomes and its procedural risks.

“Given the current lack of evidence, additional well-designed prospective comparative studies are needed to support a more unified diagnostic and therapeutic pathway for the treatment of these complex cases,” the authors concluded.

The authors reported no grant support or funding sources for this report. Several authors disclosed financial relationships with companies such as Olympus America, Medtronic, and Microtech.
 

Endoscopic ultrasound (EUS)–guided through-the-needle biopsies (TTNBs) of pancreatic cystic lesions are sufficient for accurate molecular analysis, which offers a superior alternative to cyst fluid obtained via fine-needle aspiration, based on a prospective study.

For highest diagnostic clarity, next-generation sequencing (NGS) of TTNBs can be paired with histology, lead author Charlotte Vestrup Rift, MD, PhD, of Copenhagen University Hospital, and colleagues reported.

“The diagnostic algorithm for the management of [pancreatic cystic lesions] includes endoscopic ultrasound examination with aspiration of cyst fluid for cytology,” the investigators wrote in Gastrointestinal Endoscopy. “However, the reported sensitivity of cytology is low [at 54%]. A new microforceps, introduced through a 19-gauge needle, has proven useful for procurement of [TTNBs] that represent both the epithelial and stromal component of the cyst wall. TTNBs have a high sensitivity of 86% for the diagnosis of mucinous cysts.”

Dr. Rift and colleagues evaluated the impact of introducing NGS to the diagnostic process. They noted that concomitant mutations in GNAS and KRAS are diagnostic for intraductal papillary mucinous neoplasms (IPMNs), while other mutations have been linked with progression to cancer.

The study involved 101 patients with pancreatic cystic lesions larger than 15 mm in diameter, mean age of 68 years, among whom 91 had residual TTNBs available after microscopic analysis. These samples underwent a 51-gene NGS panel that included the “most prevalent hot-spot mutations.” Diagnoses were sorted into four categories: neoplastic cyst, mucinous cyst, IPMN, or serous cystic neoplasm.

The primary endpoint was diagnostic yield, both for molecular analysis of TTNBs and for molecular analysis plus histopathology of TTNBs. Sensitivity and specificity of NGS were also determined using histopathology as the gold standard.

Relying on NGS alone, diagnostic yields were 44.5% and 27.7% for detecting a mucinous cyst and determining type of cyst, respectively. These yields rose to 73.3% and 70.3%, respectively, when NGS was used with microscopic evaluation. Continuing with this combined approach, sensitivity and specificity were 83.7% and 81.8%, respectively, for the diagnosis of a mucinous cyst. Sensitivity and specificity were higher still, at 87.2% and 84.6%, respectively, for identifying IPMNs.

The adverse-event rate was 9.9%, with a risk of postprocedure acute pancreatitis of 8.9 % and procedure-associated intracystic bleeding of 3%, according to the authors.

Limitations of the study include the relatively small sample size and the single-center design.

“TTNB-NGS is not sufficient as a stand-alone diagnostic tool as of yet but has a high diagnostic yield when combined with microscopic evaluation and subtyping by immunohistochemistry,” the investigators concluded. “The advantage of EUS-TTNB over EUS–[fine-needle aspiration] is the ability to perform detailed cyst subtyping and the high technical success rate of the procedure. ... However, the procedure comes with a risk of adverse events and thus should be offered to patients where the value of an exact diagnosis outweighs the risks.”

“Molecular subtyping is emerging as a useful clinical test for diagnosing pancreatic cysts,” said Margaret Geraldine Keane, MBBS, MSc, of Johns Hopkins Medicine, Baltimore, although she noted that NGS remains expensive and sporadically available, “which limits its clinical utility and incorporation into diagnostic algorithms for pancreatic cysts. In the future, as the cost of sequencing reduces, and availability improves, this may change.”

For now, Dr. Keane advised physicians to reserve molecular subtyping for cases in which “accurate cyst subtyping will change management ... or when other tests have not provided a clear diagnosis.”

She said the present study is valuable because better diagnostic tests are badly needed for patients with pancreatic cysts, considering the high rate of surgical overtreatment.

“Having more diagnostic tests, such as those described in this publication [to be used on their own or in combination] to decide which patients need surgery, is important,” Dr. Keane said who was not involved in the study.

Better diagnostic tests could also improve outcomes for patients with pancreatic cancer, she said, noting a 5-year survival rate of 10%.

“This outcome is in large part attributable to the late stage at which the majority of patients are diagnosed,” Dr. Keane said. “If patients can be diagnosed earlier, survival dramatically improves. Improvements in diagnostic tests for premalignant pancreatic cystic lesions are therefore vital.”

The study was supported by Rigshospitalets Research Foundation, The Novo Nordisk Foundation, The Danish Cancer Society, and others, although they did not have a role in conducting the study or preparing the manuscript. One investigator disclosed a relationship with MediGlobe. The other investigators reported no conflicts of interest. Dr. Keane disclosed no conflicts of interest.

Endoscopic ultrasound (EUS)–guided through-the-needle biopsies (TTNBs) of pancreatic cystic lesions are sufficient for accurate molecular analysis, which offers a superior alternative to cyst fluid obtained via fine-needle aspiration, based on a prospective study.

For highest diagnostic clarity, next-generation sequencing (NGS) of TTNBs can be paired with histology, lead author Charlotte Vestrup Rift, MD, PhD, of Copenhagen University Hospital, and colleagues reported.

“The diagnostic algorithm for the management of [pancreatic cystic lesions] includes endoscopic ultrasound examination with aspiration of cyst fluid for cytology,” the investigators wrote in Gastrointestinal Endoscopy. “However, the reported sensitivity of cytology is low [at 54%]. A new microforceps, introduced through a 19-gauge needle, has proven useful for procurement of [TTNBs] that represent both the epithelial and stromal component of the cyst wall. TTNBs have a high sensitivity of 86% for the diagnosis of mucinous cysts.”

Dr. Rift and colleagues evaluated the impact of introducing NGS to the diagnostic process. They noted that concomitant mutations in GNAS and KRAS are diagnostic for intraductal papillary mucinous neoplasms (IPMNs), while other mutations have been linked with progression to cancer.

The study involved 101 patients with pancreatic cystic lesions larger than 15 mm in diameter, mean age of 68 years, among whom 91 had residual TTNBs available after microscopic analysis. These samples underwent a 51-gene NGS panel that included the “most prevalent hot-spot mutations.” Diagnoses were sorted into four categories: neoplastic cyst, mucinous cyst, IPMN, or serous cystic neoplasm.

The primary endpoint was diagnostic yield, both for molecular analysis of TTNBs and for molecular analysis plus histopathology of TTNBs. Sensitivity and specificity of NGS were also determined using histopathology as the gold standard.

Relying on NGS alone, diagnostic yields were 44.5% and 27.7% for detecting a mucinous cyst and determining type of cyst, respectively. These yields rose to 73.3% and 70.3%, respectively, when NGS was used with microscopic evaluation. Continuing with this combined approach, sensitivity and specificity were 83.7% and 81.8%, respectively, for the diagnosis of a mucinous cyst. Sensitivity and specificity were higher still, at 87.2% and 84.6%, respectively, for identifying IPMNs.

The adverse-event rate was 9.9%, with a risk of postprocedure acute pancreatitis of 8.9 % and procedure-associated intracystic bleeding of 3%, according to the authors.

Limitations of the study include the relatively small sample size and the single-center design.

“TTNB-NGS is not sufficient as a stand-alone diagnostic tool as of yet but has a high diagnostic yield when combined with microscopic evaluation and subtyping by immunohistochemistry,” the investigators concluded. “The advantage of EUS-TTNB over EUS–[fine-needle aspiration] is the ability to perform detailed cyst subtyping and the high technical success rate of the procedure. ... However, the procedure comes with a risk of adverse events and thus should be offered to patients where the value of an exact diagnosis outweighs the risks.”

“Molecular subtyping is emerging as a useful clinical test for diagnosing pancreatic cysts,” said Margaret Geraldine Keane, MBBS, MSc, of Johns Hopkins Medicine, Baltimore, although she noted that NGS remains expensive and sporadically available, “which limits its clinical utility and incorporation into diagnostic algorithms for pancreatic cysts. In the future, as the cost of sequencing reduces, and availability improves, this may change.”

For now, Dr. Keane advised physicians to reserve molecular subtyping for cases in which “accurate cyst subtyping will change management ... or when other tests have not provided a clear diagnosis.”

She said the present study is valuable because better diagnostic tests are badly needed for patients with pancreatic cysts, considering the high rate of surgical overtreatment.

“Having more diagnostic tests, such as those described in this publication [to be used on their own or in combination] to decide which patients need surgery, is important,” Dr. Keane said who was not involved in the study.

Better diagnostic tests could also improve outcomes for patients with pancreatic cancer, she said, noting a 5-year survival rate of 10%.

“This outcome is in large part attributable to the late stage at which the majority of patients are diagnosed,” Dr. Keane said. “If patients can be diagnosed earlier, survival dramatically improves. Improvements in diagnostic tests for premalignant pancreatic cystic lesions are therefore vital.”

The study was supported by Rigshospitalets Research Foundation, The Novo Nordisk Foundation, The Danish Cancer Society, and others, although they did not have a role in conducting the study or preparing the manuscript. One investigator disclosed a relationship with MediGlobe. The other investigators reported no conflicts of interest. Dr. Keane disclosed no conflicts of interest.

Endoscopic ultrasound (EUS)–guided through-the-needle biopsies (TTNBs) of pancreatic cystic lesions are sufficient for accurate molecular analysis, which offers a superior alternative to cyst fluid obtained via fine-needle aspiration, based on a prospective study.

For highest diagnostic clarity, next-generation sequencing (NGS) of TTNBs can be paired with histology, lead author Charlotte Vestrup Rift, MD, PhD, of Copenhagen University Hospital, and colleagues reported.

“The diagnostic algorithm for the management of [pancreatic cystic lesions] includes endoscopic ultrasound examination with aspiration of cyst fluid for cytology,” the investigators wrote in Gastrointestinal Endoscopy. “However, the reported sensitivity of cytology is low [at 54%]. A new microforceps, introduced through a 19-gauge needle, has proven useful for procurement of [TTNBs] that represent both the epithelial and stromal component of the cyst wall. TTNBs have a high sensitivity of 86% for the diagnosis of mucinous cysts.”

Dr. Rift and colleagues evaluated the impact of introducing NGS to the diagnostic process. They noted that concomitant mutations in GNAS and KRAS are diagnostic for intraductal papillary mucinous neoplasms (IPMNs), while other mutations have been linked with progression to cancer.

The study involved 101 patients with pancreatic cystic lesions larger than 15 mm in diameter, mean age of 68 years, among whom 91 had residual TTNBs available after microscopic analysis. These samples underwent a 51-gene NGS panel that included the “most prevalent hot-spot mutations.” Diagnoses were sorted into four categories: neoplastic cyst, mucinous cyst, IPMN, or serous cystic neoplasm.

The primary endpoint was diagnostic yield, both for molecular analysis of TTNBs and for molecular analysis plus histopathology of TTNBs. Sensitivity and specificity of NGS were also determined using histopathology as the gold standard.

Relying on NGS alone, diagnostic yields were 44.5% and 27.7% for detecting a mucinous cyst and determining type of cyst, respectively. These yields rose to 73.3% and 70.3%, respectively, when NGS was used with microscopic evaluation. Continuing with this combined approach, sensitivity and specificity were 83.7% and 81.8%, respectively, for the diagnosis of a mucinous cyst. Sensitivity and specificity were higher still, at 87.2% and 84.6%, respectively, for identifying IPMNs.

The adverse-event rate was 9.9%, with a risk of postprocedure acute pancreatitis of 8.9 % and procedure-associated intracystic bleeding of 3%, according to the authors.

Limitations of the study include the relatively small sample size and the single-center design.

“TTNB-NGS is not sufficient as a stand-alone diagnostic tool as of yet but has a high diagnostic yield when combined with microscopic evaluation and subtyping by immunohistochemistry,” the investigators concluded. “The advantage of EUS-TTNB over EUS–[fine-needle aspiration] is the ability to perform detailed cyst subtyping and the high technical success rate of the procedure. ... However, the procedure comes with a risk of adverse events and thus should be offered to patients where the value of an exact diagnosis outweighs the risks.”

“Molecular subtyping is emerging as a useful clinical test for diagnosing pancreatic cysts,” said Margaret Geraldine Keane, MBBS, MSc, of Johns Hopkins Medicine, Baltimore, although she noted that NGS remains expensive and sporadically available, “which limits its clinical utility and incorporation into diagnostic algorithms for pancreatic cysts. In the future, as the cost of sequencing reduces, and availability improves, this may change.”

For now, Dr. Keane advised physicians to reserve molecular subtyping for cases in which “accurate cyst subtyping will change management ... or when other tests have not provided a clear diagnosis.”

She said the present study is valuable because better diagnostic tests are badly needed for patients with pancreatic cysts, considering the high rate of surgical overtreatment.

“Having more diagnostic tests, such as those described in this publication [to be used on their own or in combination] to decide which patients need surgery, is important,” Dr. Keane said who was not involved in the study.

Better diagnostic tests could also improve outcomes for patients with pancreatic cancer, she said, noting a 5-year survival rate of 10%.

“This outcome is in large part attributable to the late stage at which the majority of patients are diagnosed,” Dr. Keane said. “If patients can be diagnosed earlier, survival dramatically improves. Improvements in diagnostic tests for premalignant pancreatic cystic lesions are therefore vital.”

The study was supported by Rigshospitalets Research Foundation, The Novo Nordisk Foundation, The Danish Cancer Society, and others, although they did not have a role in conducting the study or preparing the manuscript. One investigator disclosed a relationship with MediGlobe. The other investigators reported no conflicts of interest. Dr. Keane disclosed no conflicts of interest.

A procalcitonin-based algorithm could safely reduce unnecessary usage of antibiotics in patients with acute pancreatitis, based on results of a randomized controlled trial.

Physicians should consider incorporating the decision-making process into their daily practice, suggested lead author Ajith K. Siriwardena, MD, of Manchester (England) University and colleagues, who also recommended that the algorithm be added to future guidelines.

“Overuse of antibiotics and the resultant emergence of multidrug resistant microorganisms is a potent threat to the welfare of humanity in the 21st century,” the investigators wrote in The Lancet Gastroenterology & Hepatology.

Antibiotic overuse is common in cases of acute pancreatitis, they noted, because clinical features are typically insufficient to distinguish between inflammation and infection. While measuring procalcitonin can help can detect infection, “indiscriminate measurement” of the biomarker is not cost effective, according to the investigators, leading previous reviews and analyses to conclude that further research is needed before widespread usage can be recommended.

Dr. Siriwardena and colleagues aimed to meet this need by conducting a randomized controlled trial involving 260 patients hospitalized for acute pancreatitis at Manchester Royal Infirmary. Patients were randomized in a near 1:1 ratio. Both the intervention group (n = 132) and the control group (n = 128) received guideline-based care; however, in addition to standard of care, procalcitonin was measured in the intervention group at days 0, 4, and 7 then weekly. Among these patients, antibiotics were stopped or not started when procalcitonin was below 1.0 ng/mL, but antibiotics were started or continued when procalcitonin was 1.0 ng/mL or more.

The primary outcome was presence or absence of antibiotic use during hospital stay. A range of secondary outcomes were also reported, included all-cause mortality, days of antibiotic use, rates of infection, and endoscopic, radiological, or surgical intervention.

Significantly fewer patients in the procalcitonin group received antibiotics during their stay, compared with the usual-care group (45% vs. 63%), which translated to an adjusted risk difference of –15.6% (P = .0071). Patients in the procalcitonin group who did receive antibiotics received about 1 day less of antibiotic treatment.

Despite the reduced antibiotic usage, length of hospital stay was similar between groups, as were rates of clinical infection, hospital-acquired infection, death, and adverse events, which suggests that the algorithm safely reduced antibiotic usage without negatively impacting clinical outcomes, according to investigators.

“Procalcitonin-based algorithms to guide antibiotic use should be considered in the care of this group of patients and be incorporated into future guidelines on the management of acute pancreatitis,” the investigators concluded.

Aaron Sasson, MD, director of the pancreatic cancer center and codirector of the gastrointestinal oncology team at Stony Brook (N.Y.) Medicine, said the study is noteworthy because it addresses an important topic with a large prospective randomized trial; however, he pointed out some limitations.

“There are several issues with this trial,” Dr. Sasson said in a written comment. “First, it included a large percentage of patients with mild acute pancreatitis, a group of patients for whom the use of antibiotics is not controversial. Secondly, the rate of infected pancreatic necrosis was 5% in both arms of the study, indicating the lack of severity of the cohort of patients.”

Dr. Sasson said that the algorithm “could be useful” to differentiate between inflammation and infection in patients with acute pancreatitis, “but only as an adjunct with other clinical parameters.”

He suggested that the algorithm would offer more utility if it could distinguish between pancreatic necrosis and infected pancreatic necrosis. “Unfortunately, this trial did not answer this question,” he said, noting that a similar trial involving “only patients with severe pancreatitis” would be needed.

The investigators and Dr. Sasson disclosed no competing interests.

A procalcitonin-based algorithm could safely reduce unnecessary usage of antibiotics in patients with acute pancreatitis, based on results of a randomized controlled trial.

Physicians should consider incorporating the decision-making process into their daily practice, suggested lead author Ajith K. Siriwardena, MD, of Manchester (England) University and colleagues, who also recommended that the algorithm be added to future guidelines.

“Overuse of antibiotics and the resultant emergence of multidrug resistant microorganisms is a potent threat to the welfare of humanity in the 21st century,” the investigators wrote in The Lancet Gastroenterology & Hepatology.

Antibiotic overuse is common in cases of acute pancreatitis, they noted, because clinical features are typically insufficient to distinguish between inflammation and infection. While measuring procalcitonin can help can detect infection, “indiscriminate measurement” of the biomarker is not cost effective, according to the investigators, leading previous reviews and analyses to conclude that further research is needed before widespread usage can be recommended.

Dr. Siriwardena and colleagues aimed to meet this need by conducting a randomized controlled trial involving 260 patients hospitalized for acute pancreatitis at Manchester Royal Infirmary. Patients were randomized in a near 1:1 ratio. Both the intervention group (n = 132) and the control group (n = 128) received guideline-based care; however, in addition to standard of care, procalcitonin was measured in the intervention group at days 0, 4, and 7 then weekly. Among these patients, antibiotics were stopped or not started when procalcitonin was below 1.0 ng/mL, but antibiotics were started or continued when procalcitonin was 1.0 ng/mL or more.

The primary outcome was presence or absence of antibiotic use during hospital stay. A range of secondary outcomes were also reported, included all-cause mortality, days of antibiotic use, rates of infection, and endoscopic, radiological, or surgical intervention.

Significantly fewer patients in the procalcitonin group received antibiotics during their stay, compared with the usual-care group (45% vs. 63%), which translated to an adjusted risk difference of –15.6% (P = .0071). Patients in the procalcitonin group who did receive antibiotics received about 1 day less of antibiotic treatment.

Despite the reduced antibiotic usage, length of hospital stay was similar between groups, as were rates of clinical infection, hospital-acquired infection, death, and adverse events, which suggests that the algorithm safely reduced antibiotic usage without negatively impacting clinical outcomes, according to investigators.

“Procalcitonin-based algorithms to guide antibiotic use should be considered in the care of this group of patients and be incorporated into future guidelines on the management of acute pancreatitis,” the investigators concluded.

Aaron Sasson, MD, director of the pancreatic cancer center and codirector of the gastrointestinal oncology team at Stony Brook (N.Y.) Medicine, said the study is noteworthy because it addresses an important topic with a large prospective randomized trial; however, he pointed out some limitations.

“There are several issues with this trial,” Dr. Sasson said in a written comment. “First, it included a large percentage of patients with mild acute pancreatitis, a group of patients for whom the use of antibiotics is not controversial. Secondly, the rate of infected pancreatic necrosis was 5% in both arms of the study, indicating the lack of severity of the cohort of patients.”

Dr. Sasson said that the algorithm “could be useful” to differentiate between inflammation and infection in patients with acute pancreatitis, “but only as an adjunct with other clinical parameters.”

He suggested that the algorithm would offer more utility if it could distinguish between pancreatic necrosis and infected pancreatic necrosis. “Unfortunately, this trial did not answer this question,” he said, noting that a similar trial involving “only patients with severe pancreatitis” would be needed.

The investigators and Dr. Sasson disclosed no competing interests.

A procalcitonin-based algorithm could safely reduce unnecessary usage of antibiotics in patients with acute pancreatitis, based on results of a randomized controlled trial.

Physicians should consider incorporating the decision-making process into their daily practice, suggested lead author Ajith K. Siriwardena, MD, of Manchester (England) University and colleagues, who also recommended that the algorithm be added to future guidelines.

“Overuse of antibiotics and the resultant emergence of multidrug resistant microorganisms is a potent threat to the welfare of humanity in the 21st century,” the investigators wrote in The Lancet Gastroenterology & Hepatology.

Antibiotic overuse is common in cases of acute pancreatitis, they noted, because clinical features are typically insufficient to distinguish between inflammation and infection. While measuring procalcitonin can help can detect infection, “indiscriminate measurement” of the biomarker is not cost effective, according to the investigators, leading previous reviews and analyses to conclude that further research is needed before widespread usage can be recommended.

Dr. Siriwardena and colleagues aimed to meet this need by conducting a randomized controlled trial involving 260 patients hospitalized for acute pancreatitis at Manchester Royal Infirmary. Patients were randomized in a near 1:1 ratio. Both the intervention group (n = 132) and the control group (n = 128) received guideline-based care; however, in addition to standard of care, procalcitonin was measured in the intervention group at days 0, 4, and 7 then weekly. Among these patients, antibiotics were stopped or not started when procalcitonin was below 1.0 ng/mL, but antibiotics were started or continued when procalcitonin was 1.0 ng/mL or more.

The primary outcome was presence or absence of antibiotic use during hospital stay. A range of secondary outcomes were also reported, included all-cause mortality, days of antibiotic use, rates of infection, and endoscopic, radiological, or surgical intervention.

Significantly fewer patients in the procalcitonin group received antibiotics during their stay, compared with the usual-care group (45% vs. 63%), which translated to an adjusted risk difference of –15.6% (P = .0071). Patients in the procalcitonin group who did receive antibiotics received about 1 day less of antibiotic treatment.

Despite the reduced antibiotic usage, length of hospital stay was similar between groups, as were rates of clinical infection, hospital-acquired infection, death, and adverse events, which suggests that the algorithm safely reduced antibiotic usage without negatively impacting clinical outcomes, according to investigators.

“Procalcitonin-based algorithms to guide antibiotic use should be considered in the care of this group of patients and be incorporated into future guidelines on the management of acute pancreatitis,” the investigators concluded.

Aaron Sasson, MD, director of the pancreatic cancer center and codirector of the gastrointestinal oncology team at Stony Brook (N.Y.) Medicine, said the study is noteworthy because it addresses an important topic with a large prospective randomized trial; however, he pointed out some limitations.

“There are several issues with this trial,” Dr. Sasson said in a written comment. “First, it included a large percentage of patients with mild acute pancreatitis, a group of patients for whom the use of antibiotics is not controversial. Secondly, the rate of infected pancreatic necrosis was 5% in both arms of the study, indicating the lack of severity of the cohort of patients.”

Dr. Sasson said that the algorithm “could be useful” to differentiate between inflammation and infection in patients with acute pancreatitis, “but only as an adjunct with other clinical parameters.”

He suggested that the algorithm would offer more utility if it could distinguish between pancreatic necrosis and infected pancreatic necrosis. “Unfortunately, this trial did not answer this question,” he said, noting that a similar trial involving “only patients with severe pancreatitis” would be needed.

The investigators and Dr. Sasson disclosed no competing interests.

SAN DIEGO – Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week^® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

SAN DIEGO – Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week^® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

SAN DIEGO – Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week^® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

Obesity, in combination with other risk factors, is associated with increased morbidity and mortality in acute pancreatitis (AP); however, body mass index (BMI) alone is not a successful predictor of disease severity, new research shows.

“As there was no agreement or consistency between BMI and AP severity, it can be concluded that AP severity cannot be predicted successfully by examining BMI only,” reported the authors in research published recently in Pancreatology.

iStock/ThinkStock

The course of acute pancreatitis is typically mild in the majority (80%-85%) of cases; however, in severe cases, permanent organ failure can occur, with much worse outcomes and mortality rates of up to 35%.

Research has previously shown not only a link between obesity and acute pancreatitis but also an increased risk for complications and in-hospital mortality in obese patients with severe cases of acute pancreatitis – though a wide range of factors and comorbidities may complicate the association.

To more closely evaluate the course and outcomes of acute pancreatitis based on BMI classification, study authors led by Ali Tuzun Ince, MD, of the department of internal medicine, Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, analyzed retrospective data from 2010 to 2020 on 1,334 adult patients (720 female, 614 male) who were diagnosed with acute pancreatitis per the Revised Atlanta Classification (RAC) criteria.

The patients were stratified based on their BMI as normal weight, overweight, or obese and whether they had mild, moderate, or severe (with permanent organ failure) acute pancreatitis.

In terms of acute pancreatitis severity, based on RAC criteria, 57.1% of patients had mild disease, 20.4% had moderate disease, and 22.5% had severe disease.

The overall mortality rate was 9.9% (n = 132); half of these patients were obese, and 87% had severe acute pancreatitis.

The overall rate of complications was 42.9%, including 20.8% in the normal weight group, 40.6% in the overweight group, and 38.6% in the obese group.

Patients in the overweight and obese groups also had higher mortality rates (3.7% and 4.9%, respectively), interventional procedures (36% and 39%, respectively), and length of hospital stay (11.6% and 9.8%, respectively), compared with the normal-weight group.

Other factors that were significantly associated with an increased mortality risk, in addition to obesity (P = .046), included old age (P = .000), male sex (P = .05), alcohol use (P = .014), low hematocrit (P = .044), high C-reactive protein (P = .024), moderate to severe and severe acute pancreatitis (P = .02 and P < .001, respectively), and any complications (P < .001).

Risk factors associated with increased admission to the ICU differed from those for mortality, and included female gender (P = .024), smoking (P = .021), hypertriglyceridemia (P = .047), idiopathic etiology (P = .023), and moderate to severe and severe acute pancreatitis (P < .001).

Of note, there were no significant associations between BMI and either the RAC score or Balthazar CT severity index (Balthazar CTSI) groups.

Specifically, among patients considered to have severe acute pancreatitis per Balthazar CTSI, 6.3% were of normal weight, 5% were overweight, and 7.1% were obese.

“In addition, since agreement and consistency between BMI and Balthazar score cannot be determined, the Balthazar score cannot be estimated from BMI,” the authors reported.

While the prediction of prognosis in acute pancreatitis is gaining interest, the findings underscore the role of combined factors, they added.

“Although many scoring systems are currently in use attempt to estimate the severity [in acute pancreatitis], none is 100% accurate yet,” the authors noted. “Each risk factor exacerbates the course of disease. Therefore, it would be better to consider the combined effects of risk factors.”

That being said, the findings show “mortality is increased significantly by the combined presence of risk factors such as male sex, OB [obesity], alcohol, MSAP [moderate to severe acute pancreatitis] and SAP [severe acute pancreatitis], all kinds of complications, old age, low Hct, and high CRP,” they wrote.
 

Obesity’s complex interactions

Commenting on the study, Vijay P. Singh, MD, a professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Scottsdale, Ariz., agreed that the complexities risk factors, particularly with obesity, can be tricky to detangle.

“Broadly, the study confirms several previous reports from different parts of the world that obesity was associated with increased mortality in acute pancreatitis,” he said in an interview.

“However, obesity had two complex interactions, the first that obesity is also associated with increased diabetes, and hypertriglyceridemia, which may themselves be risk factors for severity,” he explained.

“The second one is that intermediary severity markers [e.g., Balthazar score on imaging] did not correlate with the BMI categories.”

Dr. Singh noted that is “likely because therapies like IV fluids that may get more intense in predicted severe disease alter the natural course of pancreatitis.”

The findings are a reminder that “BMI is only a number that attempts to quantify fat,” Dr. Singh said, noting that BMI doesn’t address either the location of fat, such as being in close proximity to the pancreas, or fat composition, such as the proportion of unsaturated fat.

“When the unsaturated fat proportion is higher, the pancreatitis is worse, even at smaller total fat amounts [for example, at a lower BMI],” he said. “Taking these aspects into account may help in risk assessment.”

The authors and Dr. Singh had no disclosures to report.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.

LAS VEGAS – New results from a single center, retrospective analysis suggest that individuals with diabetes and pancreatic cysts have larger cyst sizes at diagnosis, and a faster subsequent cyst growth rate. Smoking was independently associated with faster growth rate.

iStock/ThinkStock

Most pancreatic cancer patients were previously diagnosed with hyperglycemia and diabetes, and pancreatic cancer can cause diabetes. “This sort of dual causality raises questions as to whether or not hyperglycemia, or the new diagnosis of diabetes itself, could be a harbinger of cancer or precancer. And should these patients be more closely monitored?” David Robbins, MD, said in an interview.

MDedge News

Dr. Robbins, associate professor of medicine and program director in gastroenterology in the Northwell Health System, New York, presented the study at the annual meeting of the American College of Gastroenterology.

Faster growth rates of pancreatic cysts in the presence of diabetes are important because they represent a potential mark for cyst aggressiveness. “So the question really is, in the setting of diabetes, are there factors perhaps circulating in the bloodstream, or other intrinsic factors, that make these cysts more dangerous and require a different surveillance approach than someone who doesn’t have diabetes? We have (surveillance) guidelines that address the average population, but they don’t really hone in on what do you do with (individuals with diabetes),” Dr. Robbins said during the presentation.

The study could have implications for screening, said session moderator Dayna Early, MD, professor of medicine at Washington University and director of endoscopy at Barnes Jewish Hospital, both in St. Louis. “I think this is important information to guide us to look more closely at patients with diabetes who do have pancreatic cysts,” she said in an interview.

The study included 177 adults with pancreatic cysts or abnormal imaging results between 2013 and 2020. Sixty-five percent were female, and the mean age was 65.4 years; 64% were White, 10% were Black, and 8.5% were Asian. Among the participants, 24.8% were smokers and 32.2% had type 2 diabetes.

Patients with diabetes had larger cyst sizes (2.23 cm versus 2.76 cm), as well as a higher annual cyst growth rate (1.90 cm versus 1.30 cm). Cyst size and growth rate were similar between patients with controlled and uncontrolled diabetes. Smoking was associated with a larger cyst size overall (2.2 cm versus 1.81 cm), and were larger still among patients with diabetes who smoked (2.35 cm).

Seventy-one patients went on to have pathologic confirmation by endoscopic ultrasound-guided fine needle aspiration. “In the diabetic group, two developed adenocarcinoma, six of the nondiabetics developed adenocarcinoma, and there was no difference in CEA or serum CA 19-9,” Dr. Robbins said during his presentation.

Of 28 patients diagnosed with pancreatic cancer, 13 had type 2 diabetes.
 

Defining danger

There remains uncertainty about what cyst growth rate is most dangerous. Some guidelines recommend that individuals with new-onset or worsening diabetes and intraductal papillary mucinous neoplasm or mucinous cystic neoplasm cysts, or cysts alone that are growing faster than 3 mm per year, may be at significantly increased risk of pancreatic cancer. These guidelines recommend that they be screened with short-interval magnetic resonance imaging or endoscopic ultrasound (EUS) fine needle aspiration. However, this recommendation is conditional and is backed by a very low level of evidence.

Other reports have shown varying risks at different growth rates. “It’s not really clear at this point. And that’s why I think, while our study is small and exploratory, this is a particular area that is relatively easy to evaluate. We have huge databases of pancreatic cyst evolution, and we know that 30 million Americans have diabetes. So, the next obvious study is to do a more systematic look at that, and work towards refining and making sense of these divergent guidelines, all of which are saying the same thing but using different threshold numbers,” said Dr. Robbins.

The next step is do larger, multicenter studies in the context of other risk factors such as family history and smoking, but the current finding represents an opportunity to catch at least some pancreatic cancers earlier, according to Dr. Robbins. He suggested that individuals with diabetes who are diagnosed with a pancreatic cyst should be referred to a gastroenterologist or another specialist to track cyst growth. “That is going to miss a lot of folks who didn’t get imaging for whatever reason (and so don’t have a cyst identified), but it is an early opportunity, and it’s better than what we’re doing now.”

During the talk, Dr. Robbins said, “Given the ease, availability and low cost of diabetes screening in the general clinic population, we encourage the inclusion of HbA1c and fasting glucose in algorithms for pancreatic cyst surveillance.”

Dr. Early found the suggestion intriguing, but wasn’t ready to lend full support. “I think looking at the suggestion of possibly monitoring hemoglobin A1c levels was novel. I don’t know that we’ll necessarily adopt that as standard practice, but that’s something I think that could be looked at in the future as a way to help risk stratify whether patients need to be surveyed more frequently,” she said.

Dr. Robbins and Dr. Early have no relevant financial disclosures.