Sexual minorities seeking abortion report high levels of male violence

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Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

 

 

Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.

The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

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Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

 

 

Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.

The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

 

Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

 

 

Still, Dr. Jones and her associates wrote, the study has strengths. “Health care providers, including those working in abortion settings, need to be aware that a proportion of their patient population identifies as something other than heterosexual,” they wrote.

The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

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Key clinical point: Sexual minority women who seek abortion are much more likely than are heterosexuals to report exposure to sexual and physical violence.

Major finding: Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals (P less than .001), and 3% of bisexuals. Lesbians (33%) were more likely than were heterosexuals (4%) to say the man who impregnated them had physically and/or sexually abused them.

Study details: A 2014 survey of 8,380 women seeking abortions at 87 U.S. nonhospital facilities.

Disclosures: The study was funded by the Susan Thompson Buffett Foundation with support from the National Institutes of Health via a grant to the Guttmacher Center for Population Research Innovation and Dissemination. The study authors reported no relevant financial disclosures.

Source: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.
 

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Three Clinical Studies Demonstrating Safety and Efficacy of Treatment for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) in Adults

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In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.

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  • The role of microbial imbalance and altered gut microbiota
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In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.

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  • IBS-D diagnosis and treatment challenges
  • The role of microbial imbalance and altered gut microbiota
  • A treatment option for relief of IBS-D symptoms

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In this supplement to Clinician Reviews, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined.

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  • The role of microbial imbalance and altered gut microbiota
  • A treatment option for relief of IBS-D symptoms

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Three Clinical Studies Demonstrating Safety and Efficacy of Treatment for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) in Adults

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In this supplement to Family Practice News, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined. 

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In this supplement to Family Practice News, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined. 

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In this supplement to GI & Hepatology news, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined. 

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  • IBS-D diagnosis and treatment challenges
  • The role of microbial imbalance and altered gut microbiota
  • A treatment option for relief of IBS-D symptoms

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In this supplement to GI & Hepatology news, Christine Frissora, MD, provides an overview of the burdens that patients with IBS-D experience. Three clinical efficacy and safety studies surrounding an FDA-approved treatment are also examined. 

Topics include:

  • IBS-D diagnosis and treatment challenges
  • The role of microbial imbalance and altered gut microbiota
  • A treatment option for relief of IBS-D symptoms

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CDC supports Ebola response in DRC

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The Centers for Disease Control and Prevention has been working with the Ministry of Health of the Democratic Republic of the Congo (DRC) on a new Ebola outbreak reported on Aug, 1, 2018, in North Kivu province.



“For the current outbreak, CDC has deployed experienced Ebola experts to DRC and the World Health Organization [WHO] to provide guidance on coordination of outbreak response, laboratory testing, disease contact tracing, infection control, and health communication,” according to a CDC press release.

The CDC’s online response also provides a Traveler’s Health notice of Watch Level 1 for the DRC, which advises standard precautions and avoiding infected individuals, but not an advisory against travel.

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Region of the Democratic Republic of the Congo where the August 2018 ebolavirus outbreak is occurring.


The Ebola virus associated with the current outbreak is Zaire ebolavirus, according to genetic testing by scientists in the DRC. This is the same species that caused an outbreak earlier this year in Equateur province in northwestern DRC, although differences between the genes of the viruses suggest the two outbreaks are not linked, according to the CDC media announcement.

As of Aug. 12, 2018, the following statistics were reported by the WHO on the outbreak:

  • Confirmed cases: 30
  • Probable cases: 27
  • Total cases: 57
  • Deaths: 41 (14 confirmed, 27 probable)

The outbreak is of particular concern because of the instability of the area, which hampers relief and quarantine efforts. The outbreak is in a part of the country identified by the U.S. State Department as a “restricted travel” zone due to armed conflict and violence targeting civilians, according to the CDC.

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The Centers for Disease Control and Prevention has been working with the Ministry of Health of the Democratic Republic of the Congo (DRC) on a new Ebola outbreak reported on Aug, 1, 2018, in North Kivu province.



“For the current outbreak, CDC has deployed experienced Ebola experts to DRC and the World Health Organization [WHO] to provide guidance on coordination of outbreak response, laboratory testing, disease contact tracing, infection control, and health communication,” according to a CDC press release.

The CDC’s online response also provides a Traveler’s Health notice of Watch Level 1 for the DRC, which advises standard precautions and avoiding infected individuals, but not an advisory against travel.

CDC
Region of the Democratic Republic of the Congo where the August 2018 ebolavirus outbreak is occurring.


The Ebola virus associated with the current outbreak is Zaire ebolavirus, according to genetic testing by scientists in the DRC. This is the same species that caused an outbreak earlier this year in Equateur province in northwestern DRC, although differences between the genes of the viruses suggest the two outbreaks are not linked, according to the CDC media announcement.

As of Aug. 12, 2018, the following statistics were reported by the WHO on the outbreak:

  • Confirmed cases: 30
  • Probable cases: 27
  • Total cases: 57
  • Deaths: 41 (14 confirmed, 27 probable)

The outbreak is of particular concern because of the instability of the area, which hampers relief and quarantine efforts. The outbreak is in a part of the country identified by the U.S. State Department as a “restricted travel” zone due to armed conflict and violence targeting civilians, according to the CDC.

 

The Centers for Disease Control and Prevention has been working with the Ministry of Health of the Democratic Republic of the Congo (DRC) on a new Ebola outbreak reported on Aug, 1, 2018, in North Kivu province.



“For the current outbreak, CDC has deployed experienced Ebola experts to DRC and the World Health Organization [WHO] to provide guidance on coordination of outbreak response, laboratory testing, disease contact tracing, infection control, and health communication,” according to a CDC press release.

The CDC’s online response also provides a Traveler’s Health notice of Watch Level 1 for the DRC, which advises standard precautions and avoiding infected individuals, but not an advisory against travel.

CDC
Region of the Democratic Republic of the Congo where the August 2018 ebolavirus outbreak is occurring.


The Ebola virus associated with the current outbreak is Zaire ebolavirus, according to genetic testing by scientists in the DRC. This is the same species that caused an outbreak earlier this year in Equateur province in northwestern DRC, although differences between the genes of the viruses suggest the two outbreaks are not linked, according to the CDC media announcement.

As of Aug. 12, 2018, the following statistics were reported by the WHO on the outbreak:

  • Confirmed cases: 30
  • Probable cases: 27
  • Total cases: 57
  • Deaths: 41 (14 confirmed, 27 probable)

The outbreak is of particular concern because of the instability of the area, which hampers relief and quarantine efforts. The outbreak is in a part of the country identified by the U.S. State Department as a “restricted travel” zone due to armed conflict and violence targeting civilians, according to the CDC.

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French warn of upsurge in pneumococcal meningitis

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– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

 

– A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News
Dr. Naim Ouldali

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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Key clinical point: The recent rapid emergence of serotype 24F as a cause of pediatric pneumococcal meningitis in France could mark the beginning of a resurgent epidemic.

Major finding: The incidence of pneumococcal meningitis in French children jumped by 2.3% per month during 2015-2016.

Study details: This population-based interrupted time-series analysis included all 1,778 cases of pneumococcal meningitis in children under age 15 years during 2001-2016 in 227 French pediatric wards.

Disclosures: The study was funded by a grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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TBI linked to increased suicide risk

Findings provide insight into TBI-suicide link
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Traumatic brain injury might be associated with an increased risk of suicide, according to results published Aug. 14 in JAMA.

In a retrospective cohort study of 7,418,391 Danish individuals, including 34,529 who died by suicide, patients with medical contact for traumatic brain injury (TBI) had increased suicide risk, compared with the general population (adjusted incidence rate ratio [IRR] = 1.90; 95% confidence interval, 1.83-1.97).

Patients were aged 10 years or older, and follow-up was conducted from Jan. 1, 1980, until date of death, emigration from Denmark, or Dec. 31, 2014, whichever came first. Data were obtained from national registries, including the Danish Civil Registration System, the Database for Integrated Labour Market Research, the National Hospital Register, the Psychiatric Central Research Register, and the Cause of Death Register. Associations between the separate registries were possible because of unique identification numbers assigned to every resident of Denmark, wrote Trine Madsen, PhD, of the Danish Research Institute of Suicide Prevention at the Mental Health Centre Copenhagen, Capital Region of Denmark, and her coauthors.

TBI was recorded in the National Patient Register and was categorized into three types of injury: mild TBI (concussion), skull fracture without documented TBI, and severe TBI (head injury with evidence of structural brain injury). The number of medical contacts for distinct TBI events, accumulated number of days in hospital treatment, age at first TBI, and time since last medical contact for TBI also were assessed.

Data on psychiatric illness and nonfatal self-harm were obtained from the Psychiatric Central Research Register, because of their association with suicide. Data for deaths by suicide were obtained from the Cause of Death Register. Demographic data collected from other registries included sex, age, marital status, cohabitation status, education, and socioeconomic status. IRRs were calculated using adjusted Poisson regression models.

Of 7,418,391 residents of Denmark included in the follow-up period from 1980 to 2014; 567,823 had a TBI diagnosis. Dr. Madsen and her coauthors also found that 423,502 patients (5.7%) were diagnosed with mild TBI, 24,221 (0.3%) with skull fracture, and 120,100 (1.6%) with severe TBI. A total of 34,529 died by suicide.

Of those who died by suicide, 3,536 (10.2%) had a previous TBI diagnosis (2,701 with mild TBI, 174 with skull fracture, and 661 with severe TBI). The absolute rate of suicide in individuals with hospital contact for TBI was 40.6 per 100,000 person-years (95% CI, 39.2-41.9), compared with 19.9 per 100,000 person-years (95% CI, 19.7-20.1) in those with no hospital contact for TBI.

The fully adjusted analysis showed an IRR of 1.90 (95% CI, 1.83-1.97), as well as an increased risk of suicide by TBI severity. The absolute rate for mild TBI was 38.6 per 100,000 person-years (95% CI, 37.1-40.0) with an IRR of 1.81 (95% CI, 1.74-1.88); 42.4 per 100,000 person-years for skull fracture (95% CI, 36.1-48.7) with an IRR of 2.01 (95% CI, 1.73-2.34, P less than .001), and 50.8 per 100,000 person-years for severe TBI (95% CI, 46.9-54.6) with an IRR of 2.38 (95% CI, 2.20-2.58, P less than .001), compared with individuals with no TBI, the authors wrote.

 

 

Patients with a first medical contact between 16 and 20 years of age had the highest suicide risk, compared with individuals with no TBI (IRR, 3.01; 95% CI, 2.74-3.30). In addition, individuals who were diagnosed with a psychiatric illness after TBI had a higher risk of suicide than that of those with TBI only (IRR, 4.90; 95% CI, 4.55-5.29; P less than .001), as did those who had engaged in self-harm after TBI (IRR, 7.54; 95% CI, 6.91-8.22; P less than .001). Patients diagnosed with a psychological illness before their TBI had a higher risk of suicide than did those with TBI only (IRR, 2.32; 95% CI, 2.10-2.55; P less than .001), as did those who had engaged self-harm before TBI (IRR, 2.85; 95% CI, 2.53-3.19; P less than .001), the authors noted.

Dr. Madsen and her coauthors cited several limitations. One is that information was not available on which treatment patients with TBIs received. This information “would have been useful to estimate whether different treatment regimens or subsequent follow-up would have reduced the suicide risk,” they wrote. The sheer size of the study and the length of follow-up are among the study’s many strengths.

“Traumatic brain injury is a major public health problem that has many serious consequences, including suicide,” Dr. Madsen and her colleagues wrote. Since falls and traffic accidents account for the largest share of TBIs, helmet use may be a useful protective measure, particularly for injuries related to bicycling and falls that occur at work, the researchers wrote.

“The high prevalence of TBI globally emphasizes the importance for preventing TBI in order to ameliorate its sequelae, such as increased suicide risk,” they concluded.

The study was funded in part by the Mental Health Services Capital Region Denmark and the Lundbeck Foundation. No other disclosures were reported.

SOURCE: Madsen T et al. JAMA. 2018 Aug 14;320(6):580-8.

Body

 

The results of this study “add to a growing body of evidence pointing to traumatic brain injury (TBI) as an important risk factor for suicide,” Lee Goldstein, MD, PhD, and Ramon Diaz-Arrastia, MD, PhD, wrote in an editorial published with the study (JAMA. 2018 Aug 14;320:[6]:554-6).

The study also stimulates key questions for research, Dr. Goldstein and Dr. Diaz-Arrastia wrote. “How exactly do TBIs increase suicide risk?” they wrote. “What are the substrates and processes that causally link TBI, a highly heterogeneous condition, to a singular catastrophic outcome? The answers are undoubtedly multifactorial and complex.”

Nevertheless, they wrote, the study provides important insights into the “underappreciated relationship” between TBI and suicide, including evidence of a clinical “triad”: TBI history, recent injury, and more numerous post-injury medical contacts for TBI – that may serve as “red flags” for increased suicide risk. “Notably, the results of this study indicate that increased suicide risk is relevant across all TBI severity levels, including the far more common mild injuries. Clinicians, health care professionals, and mental health practitioners must take notice of this important information.”

Dr. Goldstein is affiliated with the department of psychiatry at Boston University and reported no conflicts of interest. Dr. Diaz-Arrastia is affiliated with the department of neurology at the University of Pennsylvania, Philadelphia, and also reported no conflicts of interest.

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The results of this study “add to a growing body of evidence pointing to traumatic brain injury (TBI) as an important risk factor for suicide,” Lee Goldstein, MD, PhD, and Ramon Diaz-Arrastia, MD, PhD, wrote in an editorial published with the study (JAMA. 2018 Aug 14;320:[6]:554-6).

The study also stimulates key questions for research, Dr. Goldstein and Dr. Diaz-Arrastia wrote. “How exactly do TBIs increase suicide risk?” they wrote. “What are the substrates and processes that causally link TBI, a highly heterogeneous condition, to a singular catastrophic outcome? The answers are undoubtedly multifactorial and complex.”

Nevertheless, they wrote, the study provides important insights into the “underappreciated relationship” between TBI and suicide, including evidence of a clinical “triad”: TBI history, recent injury, and more numerous post-injury medical contacts for TBI – that may serve as “red flags” for increased suicide risk. “Notably, the results of this study indicate that increased suicide risk is relevant across all TBI severity levels, including the far more common mild injuries. Clinicians, health care professionals, and mental health practitioners must take notice of this important information.”

Dr. Goldstein is affiliated with the department of psychiatry at Boston University and reported no conflicts of interest. Dr. Diaz-Arrastia is affiliated with the department of neurology at the University of Pennsylvania, Philadelphia, and also reported no conflicts of interest.

Body

 

The results of this study “add to a growing body of evidence pointing to traumatic brain injury (TBI) as an important risk factor for suicide,” Lee Goldstein, MD, PhD, and Ramon Diaz-Arrastia, MD, PhD, wrote in an editorial published with the study (JAMA. 2018 Aug 14;320:[6]:554-6).

The study also stimulates key questions for research, Dr. Goldstein and Dr. Diaz-Arrastia wrote. “How exactly do TBIs increase suicide risk?” they wrote. “What are the substrates and processes that causally link TBI, a highly heterogeneous condition, to a singular catastrophic outcome? The answers are undoubtedly multifactorial and complex.”

Nevertheless, they wrote, the study provides important insights into the “underappreciated relationship” between TBI and suicide, including evidence of a clinical “triad”: TBI history, recent injury, and more numerous post-injury medical contacts for TBI – that may serve as “red flags” for increased suicide risk. “Notably, the results of this study indicate that increased suicide risk is relevant across all TBI severity levels, including the far more common mild injuries. Clinicians, health care professionals, and mental health practitioners must take notice of this important information.”

Dr. Goldstein is affiliated with the department of psychiatry at Boston University and reported no conflicts of interest. Dr. Diaz-Arrastia is affiliated with the department of neurology at the University of Pennsylvania, Philadelphia, and also reported no conflicts of interest.

Title
Findings provide insight into TBI-suicide link
Findings provide insight into TBI-suicide link

 

Traumatic brain injury might be associated with an increased risk of suicide, according to results published Aug. 14 in JAMA.

In a retrospective cohort study of 7,418,391 Danish individuals, including 34,529 who died by suicide, patients with medical contact for traumatic brain injury (TBI) had increased suicide risk, compared with the general population (adjusted incidence rate ratio [IRR] = 1.90; 95% confidence interval, 1.83-1.97).

Patients were aged 10 years or older, and follow-up was conducted from Jan. 1, 1980, until date of death, emigration from Denmark, or Dec. 31, 2014, whichever came first. Data were obtained from national registries, including the Danish Civil Registration System, the Database for Integrated Labour Market Research, the National Hospital Register, the Psychiatric Central Research Register, and the Cause of Death Register. Associations between the separate registries were possible because of unique identification numbers assigned to every resident of Denmark, wrote Trine Madsen, PhD, of the Danish Research Institute of Suicide Prevention at the Mental Health Centre Copenhagen, Capital Region of Denmark, and her coauthors.

TBI was recorded in the National Patient Register and was categorized into three types of injury: mild TBI (concussion), skull fracture without documented TBI, and severe TBI (head injury with evidence of structural brain injury). The number of medical contacts for distinct TBI events, accumulated number of days in hospital treatment, age at first TBI, and time since last medical contact for TBI also were assessed.

Data on psychiatric illness and nonfatal self-harm were obtained from the Psychiatric Central Research Register, because of their association with suicide. Data for deaths by suicide were obtained from the Cause of Death Register. Demographic data collected from other registries included sex, age, marital status, cohabitation status, education, and socioeconomic status. IRRs were calculated using adjusted Poisson regression models.

Of 7,418,391 residents of Denmark included in the follow-up period from 1980 to 2014; 567,823 had a TBI diagnosis. Dr. Madsen and her coauthors also found that 423,502 patients (5.7%) were diagnosed with mild TBI, 24,221 (0.3%) with skull fracture, and 120,100 (1.6%) with severe TBI. A total of 34,529 died by suicide.

Of those who died by suicide, 3,536 (10.2%) had a previous TBI diagnosis (2,701 with mild TBI, 174 with skull fracture, and 661 with severe TBI). The absolute rate of suicide in individuals with hospital contact for TBI was 40.6 per 100,000 person-years (95% CI, 39.2-41.9), compared with 19.9 per 100,000 person-years (95% CI, 19.7-20.1) in those with no hospital contact for TBI.

The fully adjusted analysis showed an IRR of 1.90 (95% CI, 1.83-1.97), as well as an increased risk of suicide by TBI severity. The absolute rate for mild TBI was 38.6 per 100,000 person-years (95% CI, 37.1-40.0) with an IRR of 1.81 (95% CI, 1.74-1.88); 42.4 per 100,000 person-years for skull fracture (95% CI, 36.1-48.7) with an IRR of 2.01 (95% CI, 1.73-2.34, P less than .001), and 50.8 per 100,000 person-years for severe TBI (95% CI, 46.9-54.6) with an IRR of 2.38 (95% CI, 2.20-2.58, P less than .001), compared with individuals with no TBI, the authors wrote.

 

 

Patients with a first medical contact between 16 and 20 years of age had the highest suicide risk, compared with individuals with no TBI (IRR, 3.01; 95% CI, 2.74-3.30). In addition, individuals who were diagnosed with a psychiatric illness after TBI had a higher risk of suicide than that of those with TBI only (IRR, 4.90; 95% CI, 4.55-5.29; P less than .001), as did those who had engaged in self-harm after TBI (IRR, 7.54; 95% CI, 6.91-8.22; P less than .001). Patients diagnosed with a psychological illness before their TBI had a higher risk of suicide than did those with TBI only (IRR, 2.32; 95% CI, 2.10-2.55; P less than .001), as did those who had engaged self-harm before TBI (IRR, 2.85; 95% CI, 2.53-3.19; P less than .001), the authors noted.

Dr. Madsen and her coauthors cited several limitations. One is that information was not available on which treatment patients with TBIs received. This information “would have been useful to estimate whether different treatment regimens or subsequent follow-up would have reduced the suicide risk,” they wrote. The sheer size of the study and the length of follow-up are among the study’s many strengths.

“Traumatic brain injury is a major public health problem that has many serious consequences, including suicide,” Dr. Madsen and her colleagues wrote. Since falls and traffic accidents account for the largest share of TBIs, helmet use may be a useful protective measure, particularly for injuries related to bicycling and falls that occur at work, the researchers wrote.

“The high prevalence of TBI globally emphasizes the importance for preventing TBI in order to ameliorate its sequelae, such as increased suicide risk,” they concluded.

The study was funded in part by the Mental Health Services Capital Region Denmark and the Lundbeck Foundation. No other disclosures were reported.

SOURCE: Madsen T et al. JAMA. 2018 Aug 14;320(6):580-8.

 

Traumatic brain injury might be associated with an increased risk of suicide, according to results published Aug. 14 in JAMA.

In a retrospective cohort study of 7,418,391 Danish individuals, including 34,529 who died by suicide, patients with medical contact for traumatic brain injury (TBI) had increased suicide risk, compared with the general population (adjusted incidence rate ratio [IRR] = 1.90; 95% confidence interval, 1.83-1.97).

Patients were aged 10 years or older, and follow-up was conducted from Jan. 1, 1980, until date of death, emigration from Denmark, or Dec. 31, 2014, whichever came first. Data were obtained from national registries, including the Danish Civil Registration System, the Database for Integrated Labour Market Research, the National Hospital Register, the Psychiatric Central Research Register, and the Cause of Death Register. Associations between the separate registries were possible because of unique identification numbers assigned to every resident of Denmark, wrote Trine Madsen, PhD, of the Danish Research Institute of Suicide Prevention at the Mental Health Centre Copenhagen, Capital Region of Denmark, and her coauthors.

TBI was recorded in the National Patient Register and was categorized into three types of injury: mild TBI (concussion), skull fracture without documented TBI, and severe TBI (head injury with evidence of structural brain injury). The number of medical contacts for distinct TBI events, accumulated number of days in hospital treatment, age at first TBI, and time since last medical contact for TBI also were assessed.

Data on psychiatric illness and nonfatal self-harm were obtained from the Psychiatric Central Research Register, because of their association with suicide. Data for deaths by suicide were obtained from the Cause of Death Register. Demographic data collected from other registries included sex, age, marital status, cohabitation status, education, and socioeconomic status. IRRs were calculated using adjusted Poisson regression models.

Of 7,418,391 residents of Denmark included in the follow-up period from 1980 to 2014; 567,823 had a TBI diagnosis. Dr. Madsen and her coauthors also found that 423,502 patients (5.7%) were diagnosed with mild TBI, 24,221 (0.3%) with skull fracture, and 120,100 (1.6%) with severe TBI. A total of 34,529 died by suicide.

Of those who died by suicide, 3,536 (10.2%) had a previous TBI diagnosis (2,701 with mild TBI, 174 with skull fracture, and 661 with severe TBI). The absolute rate of suicide in individuals with hospital contact for TBI was 40.6 per 100,000 person-years (95% CI, 39.2-41.9), compared with 19.9 per 100,000 person-years (95% CI, 19.7-20.1) in those with no hospital contact for TBI.

The fully adjusted analysis showed an IRR of 1.90 (95% CI, 1.83-1.97), as well as an increased risk of suicide by TBI severity. The absolute rate for mild TBI was 38.6 per 100,000 person-years (95% CI, 37.1-40.0) with an IRR of 1.81 (95% CI, 1.74-1.88); 42.4 per 100,000 person-years for skull fracture (95% CI, 36.1-48.7) with an IRR of 2.01 (95% CI, 1.73-2.34, P less than .001), and 50.8 per 100,000 person-years for severe TBI (95% CI, 46.9-54.6) with an IRR of 2.38 (95% CI, 2.20-2.58, P less than .001), compared with individuals with no TBI, the authors wrote.

 

 

Patients with a first medical contact between 16 and 20 years of age had the highest suicide risk, compared with individuals with no TBI (IRR, 3.01; 95% CI, 2.74-3.30). In addition, individuals who were diagnosed with a psychiatric illness after TBI had a higher risk of suicide than that of those with TBI only (IRR, 4.90; 95% CI, 4.55-5.29; P less than .001), as did those who had engaged in self-harm after TBI (IRR, 7.54; 95% CI, 6.91-8.22; P less than .001). Patients diagnosed with a psychological illness before their TBI had a higher risk of suicide than did those with TBI only (IRR, 2.32; 95% CI, 2.10-2.55; P less than .001), as did those who had engaged self-harm before TBI (IRR, 2.85; 95% CI, 2.53-3.19; P less than .001), the authors noted.

Dr. Madsen and her coauthors cited several limitations. One is that information was not available on which treatment patients with TBIs received. This information “would have been useful to estimate whether different treatment regimens or subsequent follow-up would have reduced the suicide risk,” they wrote. The sheer size of the study and the length of follow-up are among the study’s many strengths.

“Traumatic brain injury is a major public health problem that has many serious consequences, including suicide,” Dr. Madsen and her colleagues wrote. Since falls and traffic accidents account for the largest share of TBIs, helmet use may be a useful protective measure, particularly for injuries related to bicycling and falls that occur at work, the researchers wrote.

“The high prevalence of TBI globally emphasizes the importance for preventing TBI in order to ameliorate its sequelae, such as increased suicide risk,” they concluded.

The study was funded in part by the Mental Health Services Capital Region Denmark and the Lundbeck Foundation. No other disclosures were reported.

SOURCE: Madsen T et al. JAMA. 2018 Aug 14;320(6):580-8.

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Key clinical point: Helmet use might be a useful protective measure against TBI, particularly for injuries related to bicycling and falls that occur at work.

Major finding: Patients with medical contact for TBI had increased suicide risk, compared with the general population (adjusted incidence rate ratio =1.90; 95% confidence interval, 1.83-1.97).

Study details: A retrospective cohort study of 7,418,391 Danish individuals, including 34,529 who died by suicide between 1980 and 2014.

Disclosures: The study was funded in part by the Mental Health Services Capital Region Denmark and the Lundbeck Foundation. No other disclosures were reported.

Source: Madsen T et al. JAMA. 2018 Aug 14;320:(6):580-8.

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Long-acting beta2 agonists don’t impact cardiovascular risk factors

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Long-acting beta2 agonists don’t impact cardiovascular risk factors

Neither heart rate nor blood pressure worsened under long-term use of long-acting beta2 agonists olodaterol or formoterol in patients with chronic obstructive pulmonary disease (COPD), according to a post hoc pooled analysis published in Pulmonary Pharmacology & Therapeutics.

The study was conducted by Stefan Andreas, MD, department of cardiology and pneumology, University Medical Centre Göttingen, and Lung Clinic Immenhausen, Germany. The analysis evaluated data from four studies and included a total of 3,104 patients with moderate to very severe COPD, which was defined as Global Initiative for Chronic Obstructive Lung Disease stage 2-4. Patients were randomized to either once-daily olodaterol (5 or 10 mcg), twice-daily formoterol (12 mcg), or placebo. Heart rate and blood pressure were measured before and after dosing at baseline and at four time points during the study: 6 weeks, 12 weeks, 24 weeks, and 48 weeks.

At all time points, the increases seen in the placebo group were greater than seen in the treatment groups; both systolic and diastolic blood pressure showed either slight decreases from or similarities with those seen at baseline, depending on time point. Furthermore, short-term effects were seen around dosing, from before administration to after, although these changes were quantitatively small.

One limitation of the study is that it couldn’t include patients with unstable COPD because of safety reasons; this prevents the findings from being more broadly generalizable.

“These findings, in a large COPD database, speak against the potential negative cardiovascular effects of olodaterol, as well as those of formoterol,” the researchers concluded.

They reported personal fees from various industry entities, such as Novartis, AstraZeneca, and GlaxoSmithKline. Some also reported receiving personal fees from or working for Boehringer Ingelheim, which funded the work.

SOURCE: Andreas S et al. Pulm Pharmacol Ther. 2018 Aug 2. doi: 10.1016/j.pupt.2018.08.002.

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Neither heart rate nor blood pressure worsened under long-term use of long-acting beta2 agonists olodaterol or formoterol in patients with chronic obstructive pulmonary disease (COPD), according to a post hoc pooled analysis published in Pulmonary Pharmacology & Therapeutics.

The study was conducted by Stefan Andreas, MD, department of cardiology and pneumology, University Medical Centre Göttingen, and Lung Clinic Immenhausen, Germany. The analysis evaluated data from four studies and included a total of 3,104 patients with moderate to very severe COPD, which was defined as Global Initiative for Chronic Obstructive Lung Disease stage 2-4. Patients were randomized to either once-daily olodaterol (5 or 10 mcg), twice-daily formoterol (12 mcg), or placebo. Heart rate and blood pressure were measured before and after dosing at baseline and at four time points during the study: 6 weeks, 12 weeks, 24 weeks, and 48 weeks.

At all time points, the increases seen in the placebo group were greater than seen in the treatment groups; both systolic and diastolic blood pressure showed either slight decreases from or similarities with those seen at baseline, depending on time point. Furthermore, short-term effects were seen around dosing, from before administration to after, although these changes were quantitatively small.

One limitation of the study is that it couldn’t include patients with unstable COPD because of safety reasons; this prevents the findings from being more broadly generalizable.

“These findings, in a large COPD database, speak against the potential negative cardiovascular effects of olodaterol, as well as those of formoterol,” the researchers concluded.

They reported personal fees from various industry entities, such as Novartis, AstraZeneca, and GlaxoSmithKline. Some also reported receiving personal fees from or working for Boehringer Ingelheim, which funded the work.

SOURCE: Andreas S et al. Pulm Pharmacol Ther. 2018 Aug 2. doi: 10.1016/j.pupt.2018.08.002.

Neither heart rate nor blood pressure worsened under long-term use of long-acting beta2 agonists olodaterol or formoterol in patients with chronic obstructive pulmonary disease (COPD), according to a post hoc pooled analysis published in Pulmonary Pharmacology & Therapeutics.

The study was conducted by Stefan Andreas, MD, department of cardiology and pneumology, University Medical Centre Göttingen, and Lung Clinic Immenhausen, Germany. The analysis evaluated data from four studies and included a total of 3,104 patients with moderate to very severe COPD, which was defined as Global Initiative for Chronic Obstructive Lung Disease stage 2-4. Patients were randomized to either once-daily olodaterol (5 or 10 mcg), twice-daily formoterol (12 mcg), or placebo. Heart rate and blood pressure were measured before and after dosing at baseline and at four time points during the study: 6 weeks, 12 weeks, 24 weeks, and 48 weeks.

At all time points, the increases seen in the placebo group were greater than seen in the treatment groups; both systolic and diastolic blood pressure showed either slight decreases from or similarities with those seen at baseline, depending on time point. Furthermore, short-term effects were seen around dosing, from before administration to after, although these changes were quantitatively small.

One limitation of the study is that it couldn’t include patients with unstable COPD because of safety reasons; this prevents the findings from being more broadly generalizable.

“These findings, in a large COPD database, speak against the potential negative cardiovascular effects of olodaterol, as well as those of formoterol,” the researchers concluded.

They reported personal fees from various industry entities, such as Novartis, AstraZeneca, and GlaxoSmithKline. Some also reported receiving personal fees from or working for Boehringer Ingelheim, which funded the work.

SOURCE: Andreas S et al. Pulm Pharmacol Ther. 2018 Aug 2. doi: 10.1016/j.pupt.2018.08.002.

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Long-acting beta2 agonists don’t impact cardiovascular risk factors
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Key clinical point: Olodaterol and formoterol had a minimal impact on cardiovascular factors.

Major finding: Patients who were randomized to once-daily olodaterol (5 or 10 mcg), twice-daily formoterol (12 mcg), or placebo showed little change in heart rate and blood pressure at 6, 12, 24, or 48 weeks.

Study details: Post hoc pooled analysis from four studies comprising a total of 3,104 patients with moderate to very severe COPD.

Disclosures: Investigators reported personal fees from various industry entities, such as Novartis, AstraZeneca, and GlaxoSmithKline. Some also reported receiving personal fees from or working for Boehringer Ingelheim.

Source: Andreas S et al. Pulm Pharmacol Ther. 2018 Aug 2. doi: 10.1016/j.pupt.2018.08.002.
 

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Plasma GAG provides prognostic info for RCC

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Fri, 01/04/2019 - 14:22

Plasma glycosaminoglycan (GAG) measurements can accurately distinguish metastatic clear-cell renal cell carcinoma (ccRCC) from healthy samples, and can provide accurate diagnostic and prognostic information that may be of value in managing the disease, according to new findings.

A new GAG score had 93.5% sensitivity and 94.7% specificity (discovery set) for differentiating RCC from healthy samples, and the sensitivity estimate was independently validated. The score remained independent and uncorrelated to tumor stage, grade, size, and histology, or confounders such as age or gender, according to investigators. The report is in European Oncology Urology.

The authors note that in both retrospective and prospective studies of metastatic ccRCC cases, the composition and levels of plasma and urine GAGs are significantly different when compared with healthy specimens, and GAG scores have correlated with patient outcomes including progression free and overall survival in some cohorts. But it remains unclear if the alterations in plasma and urine GAGs are limited to just metastatic cases of ccRCC or if they correlate with other histopathologic characteristics in RCC. It is also unclear if the correlation between GAG scores and prognosis is limited to patients who receive systemic therapy or if it is applicable to those who are surgically treated RCC as well.

“These results expand our knowledge on the diagnostic and prognostic potential of plasma GAGs in RCC, which was so far limited to metastatic ccRCC in our previous studies,” wrote Francesco Gatto, MD, of Chalmers University of Technology, Göteborg, Sweden, and his colleagues. “Plasma GAG alterations appear to originate as a response to the tumor and occur early if not concomitantly with tumor formation, and probably independent of its progression.”

To investigate the sensitivity and specificity of plasma GAGs for detection of early-stage RCC as well as its utility in predicting recurrence and death after RCC surgery, Dr. Gatto and his team conducted a retrospective case-control study that included 175 RCC patients who underwent surgery between May 2011 and February 2014 and 19 healthy controls.

Plasma GAGs were measured in both preoperative and postoperative RCC cases and the control group, and a discovery set was analyzed to update the historical GAG score. The sensitivity of the new GAG score that was developed for detecting RCC versus controls was then validated using the remaining samples.

In the first discovery set, which included 67 participants, the new GAG score distinguished RCC from controls with an area under the receiver operating characteristic curve (AUC) of 0.999. In their validation cohort (n = 108), the new GAG score achieved an AUC of 0.991 (95% CI 0.977-1) and at the prespecified cutoff, the validated sensitivity was 93.5%. Specificity could not be validated because the same control group was used in both sets.

Factors including tumor size, grade, and stage, radical nephrectomy, and positive surgical margins were significantly associated with overall survival as were three of five GAG properties in the new scoring system, although the new GAG score did not reach significance by itself (hazard ratio, 1.25; P = 0.08). When looking at whether the new GAG score changed after surgery, the authors found that it was quite variable across patients, and an increased score was observed for 53% of cases and a decrease for 47% after surgery. This change did not appear correlated with outcomes as shown by the recurrence rate within 2 years of surgery.

SOURCE: Gatto F et al. Eur Urol Oncol. 2018 Jun 13. doi: 10.1016/j.euo.2018.04.015.

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Plasma glycosaminoglycan (GAG) measurements can accurately distinguish metastatic clear-cell renal cell carcinoma (ccRCC) from healthy samples, and can provide accurate diagnostic and prognostic information that may be of value in managing the disease, according to new findings.

A new GAG score had 93.5% sensitivity and 94.7% specificity (discovery set) for differentiating RCC from healthy samples, and the sensitivity estimate was independently validated. The score remained independent and uncorrelated to tumor stage, grade, size, and histology, or confounders such as age or gender, according to investigators. The report is in European Oncology Urology.

The authors note that in both retrospective and prospective studies of metastatic ccRCC cases, the composition and levels of plasma and urine GAGs are significantly different when compared with healthy specimens, and GAG scores have correlated with patient outcomes including progression free and overall survival in some cohorts. But it remains unclear if the alterations in plasma and urine GAGs are limited to just metastatic cases of ccRCC or if they correlate with other histopathologic characteristics in RCC. It is also unclear if the correlation between GAG scores and prognosis is limited to patients who receive systemic therapy or if it is applicable to those who are surgically treated RCC as well.

“These results expand our knowledge on the diagnostic and prognostic potential of plasma GAGs in RCC, which was so far limited to metastatic ccRCC in our previous studies,” wrote Francesco Gatto, MD, of Chalmers University of Technology, Göteborg, Sweden, and his colleagues. “Plasma GAG alterations appear to originate as a response to the tumor and occur early if not concomitantly with tumor formation, and probably independent of its progression.”

To investigate the sensitivity and specificity of plasma GAGs for detection of early-stage RCC as well as its utility in predicting recurrence and death after RCC surgery, Dr. Gatto and his team conducted a retrospective case-control study that included 175 RCC patients who underwent surgery between May 2011 and February 2014 and 19 healthy controls.

Plasma GAGs were measured in both preoperative and postoperative RCC cases and the control group, and a discovery set was analyzed to update the historical GAG score. The sensitivity of the new GAG score that was developed for detecting RCC versus controls was then validated using the remaining samples.

In the first discovery set, which included 67 participants, the new GAG score distinguished RCC from controls with an area under the receiver operating characteristic curve (AUC) of 0.999. In their validation cohort (n = 108), the new GAG score achieved an AUC of 0.991 (95% CI 0.977-1) and at the prespecified cutoff, the validated sensitivity was 93.5%. Specificity could not be validated because the same control group was used in both sets.

Factors including tumor size, grade, and stage, radical nephrectomy, and positive surgical margins were significantly associated with overall survival as were three of five GAG properties in the new scoring system, although the new GAG score did not reach significance by itself (hazard ratio, 1.25; P = 0.08). When looking at whether the new GAG score changed after surgery, the authors found that it was quite variable across patients, and an increased score was observed for 53% of cases and a decrease for 47% after surgery. This change did not appear correlated with outcomes as shown by the recurrence rate within 2 years of surgery.

SOURCE: Gatto F et al. Eur Urol Oncol. 2018 Jun 13. doi: 10.1016/j.euo.2018.04.015.

Plasma glycosaminoglycan (GAG) measurements can accurately distinguish metastatic clear-cell renal cell carcinoma (ccRCC) from healthy samples, and can provide accurate diagnostic and prognostic information that may be of value in managing the disease, according to new findings.

A new GAG score had 93.5% sensitivity and 94.7% specificity (discovery set) for differentiating RCC from healthy samples, and the sensitivity estimate was independently validated. The score remained independent and uncorrelated to tumor stage, grade, size, and histology, or confounders such as age or gender, according to investigators. The report is in European Oncology Urology.

The authors note that in both retrospective and prospective studies of metastatic ccRCC cases, the composition and levels of plasma and urine GAGs are significantly different when compared with healthy specimens, and GAG scores have correlated with patient outcomes including progression free and overall survival in some cohorts. But it remains unclear if the alterations in plasma and urine GAGs are limited to just metastatic cases of ccRCC or if they correlate with other histopathologic characteristics in RCC. It is also unclear if the correlation between GAG scores and prognosis is limited to patients who receive systemic therapy or if it is applicable to those who are surgically treated RCC as well.

“These results expand our knowledge on the diagnostic and prognostic potential of plasma GAGs in RCC, which was so far limited to metastatic ccRCC in our previous studies,” wrote Francesco Gatto, MD, of Chalmers University of Technology, Göteborg, Sweden, and his colleagues. “Plasma GAG alterations appear to originate as a response to the tumor and occur early if not concomitantly with tumor formation, and probably independent of its progression.”

To investigate the sensitivity and specificity of plasma GAGs for detection of early-stage RCC as well as its utility in predicting recurrence and death after RCC surgery, Dr. Gatto and his team conducted a retrospective case-control study that included 175 RCC patients who underwent surgery between May 2011 and February 2014 and 19 healthy controls.

Plasma GAGs were measured in both preoperative and postoperative RCC cases and the control group, and a discovery set was analyzed to update the historical GAG score. The sensitivity of the new GAG score that was developed for detecting RCC versus controls was then validated using the remaining samples.

In the first discovery set, which included 67 participants, the new GAG score distinguished RCC from controls with an area under the receiver operating characteristic curve (AUC) of 0.999. In their validation cohort (n = 108), the new GAG score achieved an AUC of 0.991 (95% CI 0.977-1) and at the prespecified cutoff, the validated sensitivity was 93.5%. Specificity could not be validated because the same control group was used in both sets.

Factors including tumor size, grade, and stage, radical nephrectomy, and positive surgical margins were significantly associated with overall survival as were three of five GAG properties in the new scoring system, although the new GAG score did not reach significance by itself (hazard ratio, 1.25; P = 0.08). When looking at whether the new GAG score changed after surgery, the authors found that it was quite variable across patients, and an increased score was observed for 53% of cases and a decrease for 47% after surgery. This change did not appear correlated with outcomes as shown by the recurrence rate within 2 years of surgery.

SOURCE: Gatto F et al. Eur Urol Oncol. 2018 Jun 13. doi: 10.1016/j.euo.2018.04.015.

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Key clinical point: GAG measurements can provide accurate diagnostic and prognostic information for surgically treated renal cell carcinoma.

Major finding: A new GAG score had 93.5% sensitivity and 94.7% specificity for differentiating RCC from controls.

Study details: Retrospective case-control study that included 175 RCC patients and 19 controls.

Disclosures: The study was funded by the Knut and Alice Wallenberg Foundation to Chalmers University of Technology and MSK Cancer Center Support Grant P30-CA008748 to the Memorial Sloan Kettering Cancer Center. Dr. Francesco Gatto and Dr. Jens Nielsen were listed as coinventors on patent applications related to the biomarkers described in this study and both are shareholders in Elypta AB, which owned the above-mentioned patent applications. There are no other disclosures.

Source: Gatto F et al. Eur Urol Oncol. 2018 Jun 13. doi: 10.1016/j.euo.2018.04.015.

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AGA Clinical Practice Update: Tumor seeding with endoscopic procedures

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Wed, 05/26/2021 - 13:49

Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

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Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

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