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What's new in gastroenterology and hepatology
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What's new in gastroenterology and hepatology

Disclosures: Peter A L Bonis, MD Nothing to disclose. Anne C Travis, MD, MSc, FACG, AGAF Equity Ownership/Stock Options: Proctor & Gamble [Peptic ulcer disease/GI bleeding (omeprazole)]. Shilpa Grover, MD, MPH Nothing to disclose.

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All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Jan 2016. | This topic last updated: Feb 01, 2016.

The following represent additions to UpToDate from the past six months that were considered by the editors and authors to be of particular interest. The most recent What's New entries are at the top of each subsection.

COLORECTAL CANCER

Laparoscopic versus open surgery for rectal cancer (October 2015)

Curative resection of a rectal carcinoma was traditionally carried out with open techniques. Although earlier randomized trials had shown that laparoscopic rectal cancer surgery was equivalent to open surgery, two subsequent trials failed to prove that laparoscopic surgery is non-inferior to open surgery [1,2]. In the two more recent trials, successful resections, defined as simultaneously achieving negative distal and circumferential margins as well as a complete total mesorectal excision, were achieved in approximately 82 percent with laparoscopic surgery versus 87 to 89 percent with open surgery. Given the conflicting results, the best surgical approach to treating rectal cancer needs to be determined individually by tumor and patient characteristics, as well as surgeon experience. When performing laparoscopic rectal surgery for cancer, surgeons should have a low threshold for converting to open surgery when difficulties arise with dissection. (See "Surgical resection of primary rectal adenocarcinoma", section on 'Laparoscopic versus open approach'.)

ESOPHAGEAL AND GASTRIC DISEASE

Oral recombinant H. pylori vaccine (October 2015)

In a randomized phase 3 trial, 4464 H. pylori uninfected children (ages 6 to 15 years) were assigned to a three-dose oral recombinant H. pylori vaccine or placebo [3]. At one year, the incidence of H. pylori infection was significantly lower in the vaccine group. Among patients who completed extended follow-up, H. pylori acquisition continued to be lower in vaccinated as compared with unvaccinated children, but protection levels were lower in the second and third year. There were no serious adverse events related to the vaccine. Additional studies with long-term follow-up are needed to validate these results. (See "Pathophysiology of and immune response to Helicobacter pylori infection", section on 'Vaccination'.)

Prediction model for eosinophilic esophagitis (September 2015)

The distinction between eosinophilic esophagitis and gastroesophageal reflux disease is often difficult to make. A prediction model that incorporated eight clinical and endoscopic features (younger age; male sex; presence of dysphagia and food allergies; presence of esophageal rings, furrows, and plaques; and lack of a hiatal hernia) predicted eosinophilic esophagitis with an accuracy, sensitivity, and specificity of 84, 97, and 92 percent, respectively [4]. However, additional studies are needed to validate this model. (See "Clinical manifestations and diagnosis of eosinophilic esophagitis", section on 'Distinction from GERD'.)

HEPATOLOGY

Hepatitis B virus reactivation in patients undergoing chemotherapy for solid tumors (January 2016)

Patients with serologic evidence of hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg]-positive or hepatitis B core antibody [anti-HBc]-positive) are at risk for HBV reactivation if they receive immunosuppressive therapy. However, the magnitude of risk for patients receiving chemotherapy for solid tumors has not been well established. In a systematic review of such patients, the risk of reactivation among those who were HBsAg-positive ranged from 4 to 68 percent, with most studies reporting a reactivation risk greater than 10 percent [5]. Antiviral therapy administered during chemotherapy was associated with an approximately 90 percent reduction in HBV reactivation risk as well as reductions in HBV-related hepatitis and the need for chemotherapy interruption. Although some expert groups disagree, we check HBV serologies before initiating therapy with any potentially immunosuppressive chemotherapy. Our recommendations for prophylactic antiviral therapy depend upon the HBsAg status of the patient and the type of chemotherapy used. (See "Hepatitis B virus reactivation associated with immunosuppressive therapy", section on 'Who is at risk for HBV reactivation'.)

Investigational combination of sofosbuvir plus velpatasvir for chronic HCV infection (November 2015)

The selection of all-oral antiviral regimens for patients with chronic hepatitis C virus (HCV) infection currently depends on the infecting genotype, treatment history, and the presence of cirrhosis. The investigational agent sofosbuvir-velpatasvir, a coformulated combination of an NS5B and an NS5A inhibitor, appears extremely effective across viral genotypes and patient characteristics, and thus offers the possibility of a streamlined approach to regimen selection. In a randomized, placebo-controlled trial of patients with genotypes 1, 2, 4, 5, and 6 infection, including those with cirrhosis and prior treatment failure with interferon-containing regimens, the sustained virologic response (SVR) rate among the 624 patients who were assigned to receive sofosbuvir-velpatasvir for 12 weeks was 99 percent [6]. In another study, the regimen resulted in an SVR rate of 98 percent among 163 treatment-naïve genotype 3-infected patients without cirrhosis [7]. SVR rates were somewhat lower, but still high (89 to 93 percent), in the setting of genotype 3 infection with cirrhosis and/or prior treatment failure. (See "Investigational therapies for hepatitis C virus infection", section on 'Sofosbuvir and velpatasvir'.)

Hepatic decompensation associated with ombitasvir-paritaprevir-ritonavir for chronic HCV infection (November 2015)

With more widespread use of ombitasvir-paritaprevir-ritonavir with or without dasabuvir for patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infection, reports of associated hepatic injury and decompensation have emerged [8]. Most cases occurred in patients with existing cirrhosis and within one to four weeks of drug initiation; some cases resulted in death or need for liver transplantation. Patients with compensated cirrhosis who use this regimen should be monitored closely for signs of decompensation and undergo interval transaminase and bilirubin testing after initiation. The regimen is contraindicated in individuals with Child B and C class cirrhosis. (See "Direct-acting antivirals for the treatment of hepatitis C virus infection", section on 'Ombitasvir-paritaprevir-ritonavir with or without dasabuvir'.)

Primary biliary cirrhosis is now known as primary biliary cholangitis (October 2015)

The term "primary biliary cirrhosis" has been used to describe the T-lymphocyte-mediated attack on small intralobular bile ducts. However, the terminology is changing to "primary biliary cholangitis" to describe the disorder and its natural history more accurately [9]. With the advent of treatment with ursodeoxycholic acid, the majority of patients now have normal life expectancies and only a minority of patients develops cirrhosis. (See "Clinical manifestations, diagnosis, and prognosis of primary biliary cholangitis (primary biliary cirrhosis)", section on 'Introduction'.)

Daclatasvir-based regimens for genotype 3 HCV infection (August 2015)

In the era of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, patients with genotype 3 infection have emerged as a difficult-to-treat population, with suboptimal sustained virologic response (SVR) rates with short courses of previously available regimens. In July 2015, the US Food and Drug Administration approved the use of the novel NS5A inhibitor daclatasvir in combination with sofosbuvir for genotype 3 HCV infection. This agent has been available in Europe and elsewhere. Daclatasvir plus sofosbuvir for 12 weeks is now our preferred regimen for genotype 3-infected patients without cirrhosis. In an open-label study that included 120 such patients, SVR rates were 96 percent with that regimen [10]. SVR rates were only 63 percent in the 32 patients with cirrhosis included in the study, although limited evidence suggests that efficacy is enhanced with the addition of ribavirin to the regimen [11,12]. Thus, daclatasvir plus sofosbuvir plus weight-based ribavirin is our preferred regimen for genotype 3-infected patients with cirrhosis; the regimen is given for 24 weeks, although the optimal duration is uncertain. Sofosbuvir plus peginterferon plus ribavirin for 12 weeks is an effective alternative for patients willing to take interferon and has more established efficacy data. Sofosbuvir plus ribavirin for 24 weeks can also result in acceptably high SVR rates for treatment-naïve patients with cirrhosis. (See "Treatment regimens for chronic hepatitis C virus genotypes 2 and 3", section on 'Genotype 3'.)

Terlipressin versus midodrine and octreotide for hepatorenal syndrome (July 2015)

Terlipressin, a vasopressin analog, is used for the treatment of hepatorenal syndrome, but is not approved for use in the United States. In a trial that randomly assigned 49 patients with hepatorenal syndrome to terlipressin plus albumin or to midodrine and octreotide plus albumin, the rate of complete response (a decrease in serum creatinine to less than 1.5 mg/dL [133 micromol/L] at 14 days) was significantly greater with terlipressin plus albumin (56 versus 5 percent) [13]. However, the partial response rate was greater with midodrine and octreotide plus albumin, and mortality rates did not differ; in addition, the dose of midodrine used was lower than often employed in clinical practice, and blood pressures were lower in the group who received midodrine and octreotide plus albumin. Thus, despite this and other limited trials showing benefit from terlipressin, it remains unclear whether this therapy is superior to the combination of midodrine and octreotide. (See "Hepatorenal syndrome", section on 'Terlipressin plus albumin where available'.)

Direct-acting antiviral therapy for HCV in HIV-infected patients (July 2015)

Although HIV-infected patients had lower response rates to chronic hepatitis C virus (HCV) treatment with peginterferon and ribavirin compared with HIV-uninfected patients, a growing number of studies have demonstrated that HIV/HCV coinfection is not associated with worse response to direct-acting antiviral-based regimens. Most recently, the regimen of ledpasvir-sofosbuvir for 12 weeks and the regimen of the investigational NS5A inhibitor daclatasvir with sofosbuvir for 12 weeks were each reported to result in sustained virologic response (SVR) rates exceeding 90 percent among HIV/HCV coinfected patients, including those who had failed prior HCV treatment and those with cirrhosis [14,15]. The efficacy and safety in these studies are comparable to those observed among HCV monoinfected patients. Potential drug interactions with antiretroviral agents remain a major consideration when selecting HCV treatment regimens in HIV-infected patients. (See "Treatment of hepatitis C virus infection in the HIV-infected patient", section on 'Genotype 1 infection'.)

PANCREATIC AND BILIARY DISEASE

Progression from acute to chronic pancreatitis (December 2015)

There are limited data on the natural history of acute pancreatitis. In a meta-analysis that included over 8000 patients with acute pancreatitis, the pooled prevalence of recurrent acute pancreatitis and chronic pancreatitis were 22 and 10 percent, respectively [16]. The prevalence of chronic pancreatitis following the first episode and following recurrent acute pancreatitis were 10 and 36 percent, respectively. Among individuals with a history of smoking or alcohol use, the prevalence of chronic pancreatitis was 65 and 61 percent, respectively. The risk of progression to chronic pancreatitis was higher in men than in women after controlling for age and severity of acute pancreatitis. (See "Clinical manifestations and diagnosis of acute pancreatitis", section on 'Disease course'.)

Pentoxifylline in severe acute pancreatitis (August 2015)

Severe acute pancreatitis has a high mortality rate. In a randomized trial, 28 patients with predicted severe acute pancreatitis were assigned to pentoxifylline or placebo within 72 hours of diagnosis [17]. Patients treated with pentoxifylline had fewer intensive care unit admissions and hospital stays longer than four days as compared with placebo. However, there were no significant differences in the levels of inflammatory markers between the two groups. Studies are needed to validate these results and define the role of pentoxifylline in the treatment of acute pancreatitis. (See "Management of acute pancreatitis", section on 'Other'.)

SMALL BOWEL AND COLONIC DISEASE

Eluxadoline for irritable bowel syndrome with diarrhea (January 2016)

Eluxadoline, a mu-opioid receptor agonist and a delta-opioid receptor antagonist, has been evaluated for treatment of irritable bowel syndrome with diarrhea (IBS-D). In two phase 3 studies, over 2000 adults with IBS-D were randomly assigned to two different doses of eluxadoline or placebo twice daily for 26 and 52 weeks, respectively [18]. The primary endpoint was the proportion of patients who had a composite response of less abdominal pain and improvement in stool consistency for at least 50 percent of the days. For weeks 1 through 26, significantly more patients receiving higher-dose eluxadoline achieved the primary endpoint (29 to 33 percent) compared with placebo (19 to 20 percent) in both trials. The most common adverse events associated with eluxadoline were nausea, constipation, and abdominal pain, and pancreatitis developed in 0.3 percent. Eluxadoline has been approved for treatment of IBS-D, but is not commercially available. Further studies are needed to identify sub-populations of patients with IBS-D who may benefit most from eluxadoline. (See "Treatment of irritable bowel syndrome in adults", section on 'Antidiarrheal agents'.)

Frozen fecal microbiota transplantation for Clostridium difficile infection (January 2016)

Treatment with fecal microbiota transplantation (FMT) has been hampered by logistic difficulties in preparation and administration of the fecal suspension. In a randomized non-inferiority trial, 219 patients with recurrent Clostridium difficile infection (CDI) or refractory CDI were assigned to receive frozen-and-thawed or fresh FMT via rectal enema [19]. In the modified intention-to-treat population, rates of clinical resolution in the frozen FMT group were non-inferior to fresh FMT, and there were no differences in adverse events between the two groups. The use of frozen FMT also has the potential advantage of immediate availability. Frozen FMT is currently an investigational technique for the treatment of C. difficile. (See "Fecal microbiota transplantation in the treatment of recurrent Clostridium difficile infection", section on 'Suggested protocol'.)

Olmesartan enteropathy (January 2016)

Olmesartan, an angiotensin receptor blocker (ARB), can produce a "sprue-like enteropathy" characterized by severe chronic diarrhea and weight loss, occurring months to years after initiation of the drug. The largest experience comes from a French cohort of over 4 million patients who initiated therapy with olmesartan, a different ARB, or an angiotensin converting enzyme (ACE) inhibitor [20]. Compared with users of ACE inhibitors, intestinal malabsorption severe enough to cause hospitalization occurred substantially more often among patients taking olmesartan for one to two years (adjusted risk ratio 3.7) and among those taking olmesartan for more than two years (adjusted risk ratio 10.6). Risk was not increased in users of other ARBs. Although a large number of patients (ie, 12,550) needed to be treated with olmesartan for two or more years to produce one additional case of enteropathy requiring hospitalization, less severe but still clinically significant cases of enteropathy may have been more frequent. Patients starting olmesartan should be cautioned about the possibility of developing diarrhea and weight loss. The drug should be stopped if these symptoms occur and another cause is not identified. (See "Major side effects of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers", section on 'Enteropathy with olmesartan'.)

Sigmoid resection versus laparoscopic lavage for perforated diverticulitis (January 2016)

The laparoscopic lavage and drainage procedure was introduced as a potentially less morbid alternative to sigmoid resection for patients with perforated diverticulitis. In the SCANDIV trial, 199 patients with perforated diverticulitis were randomized to undergo either laparoscopic lavage or sigmoid resection [21]. At 90 days, laparoscopic lavage did not improve mortality rates (14 versus 12 percent) or major morbidity rates (31 versus 26 percent) compared with sigmoid resection. Furthermore, patients who underwent laparoscopic lavage were more likely to require reoperation (20 versus 6 percent) for complications such as secondary peritonitis or missed sigmoid cancer. Based upon these results and other available data, sigmoid resection with or without fecal diversion remains the preferred intervention for patients with perforated diverticulitis. (See "Management of acute complicated diverticulitis", section on 'Laparoscopic lavage'.)

Acute diverticulitis: Risk of recurrence (December 2015)

There are limited data on the natural history of acute diverticulitis. In a population-based study that included over 3000 patients with acute diverticulitis, recurrent diverticulitis in a 10-year period after the index and second diverticulitis episode occurred in 22 and 55 percent of patients, respectively [22]. The risk of recurrence was higher in younger individuals and in women. Increasing age was associated with a higher risk of both local and systemic complications. (See "Clinical manifestations and diagnosis of acute diverticulitis in adults", section on 'Disease course'.)

Suspected small bowel bleeding should no longer be referred to as "obscure" (October 2015)

Bleeding from the small bowel is uncommon, but it is responsible for the majority of patients with gastrointestinal bleeding that persists or recurs without an obvious etiology after upper endoscopy, colonoscopy, and possibly radiologic evaluation of the small bowel [23]. In the past, if no source of bleeding was found after an endoscopic evaluation, the bleeding was referred to as being "obscure." However, a 2015 guideline from the American College of Gastroenterology has been proposed that the term obscure only be used if patients have not had a source of bleeding identified after a thorough examination of the entire gastrointestinal tract, including the small bowel [24]. Most cases of what was previously referred to as obscure bleeding are more correctly categorized as suspected small bowel bleeding. (See "Evaluation of suspected small bowel bleeding (formerly obscure gastrointestinal bleeding)", section on 'Introduction'.)

Curcumin for induction of remission in ulcerative colitis (July 2015)

Curcumin is an investigational agent that may have a protective role in ulcerative colitis through modulation of the release of tumor necrosis factor-alpha and nitric oxide. In a randomized trial, 50 patients with active mild to moderate ulcerative colitis who did not respond to two weeks of maximum-dose oral and topical mesalamine therapy were assigned to additional treatment with curcumin or placebo for one month [25]. At four weeks, patients in the curcumin group had significantly higher rates of clinical and endoscopic remission as compared with the placebo group. However, curcumin can alter the stool color in some patients, and the exceptionally low response rates in the placebo group (ie, none responded) raise concern that blinding was not adequate. Additional studies are needed to support the use of curcumin in patients with ulcerative colitis. (See "Approach to adults with steroid-refractory and steroid-dependent ulcerative colitis", section on 'Curcumin'.)

OTHER GASTROENTEROLOGY AND NUTRITION

Reversal agent for factor Xa inhibitors (November 2015)

Lack of reversal agents for the direct oral anticoagulants has been a concern. Andexanet alfa is a recombinant protein designed to reverse factor Xa inhibitors by binding to the drugs and sequestering them away from endogenous factor Xa. In a randomized trial in healthy volunteers, an andexanet bolus reduced anti-factor Xa activity by 94 percent and 92 percent for volunteers taking apixaban or rivaroxaban, respectively, compared with reductions of 21 and 18 percent for a placebo bolus [26]. A study evaluating andexanet efficacy in patients with factor Xa inhibitor-associated bleeding is ongoing. (See "Management of bleeding in patients receiving direct oral anticoagulants", section on 'Antidotes under development'.)

Mechanical bowel preparation and oral antibiotics prior to elective colon surgery (September 2015)

Traditionally, mechanical bowel preparation was used with oral antibiotics to prepare for all elective colon surgeries. After several randomized trials reported no benefit from mechanical bowel preparation (MBP) without antibiotics, colon resection without preoperative bowel preparation and without oral antibiotics became widespread. A retrospective study of data from over 8000 patients undergoing colorectal resection found that MBP combined with oral antibiotics, compared with MBP alone, was associated with lower rates of anastomotic leak, and that MBP, with or without antibiotics, was associated with lower rates of surgical site infection and postoperative ileus compared with no preparation prior to surgery [27]. A subsequent meta-analysis of seven randomized trials reached a similar conclusion [28]. One drawback is a potential increase in the rate of Clostridium difficile infection for patients treated with oral antibiotics.

Thus, for patients undergoing elective colon surgeries, we suggest mechanical bowel preparation combined with oral antibiotics. Mechanical bowel preparation is usually accomplished with polyethylene glycol solution and is followed by oral antibiotics such as neomycin and erythromycin base. Administering oral antibiotics in the absence of mechanical bowel preparation is of unproven benefit and is not advised. (See "Overview of colon resection", section on 'Bowel preparation'.)

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REFERENCES

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  2. Stevenson AR, Solomon MJ, Lumley JW, et al. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA 2015; 314:1356.
  3. Zeng M, Mao XH, Li JX, et al. Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386:1457.
  4. Dellon ES, Rusin S, Gebhart JH, et al. A Clinical Prediction Tool Identifies Cases of Eosinophilic Esophagitis Without Endoscopic Biopsy: A Prospective Study. Am J Gastroenterol 2015; 110:1347.
  5. Paul S, Saxena A, Terrin N, et al. Hepatitis B Virus Reactivation and Prophylaxis During Solid Tumor Chemotherapy: A Systematic Review and Meta-analysis. Ann Intern Med 2016; 164:30.
  6. Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med 2015; 373:2599.
  7. Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med 2015; 373:2608.
  8. FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie. October 22, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm (Accessed on October 22, 2015).
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  10. Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61:1127.
  11. Foster GR, McLaughlan J, Irving W, et al.Treatment of decompensated HCV cirrhosis in patients with diverse genotypes: 12 weeks of sofosbuvir and NS5A inhibitors with/without ribavirin is effective in HCV genotypes 1 and 3.Presented at the 50th Annual Meeting of the European Association for the Study of the Liver (EASL), Vienna Austria, April 22-26, 2015. Abstract O002
  12. Poordad F, Schiff ER, Vierling JM, et al. Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or post-transplant recurrence: ALLY-1 phase 3 study. Presented at the 50th Annual Meeting of the European Association for the Study of the Liver (EASL), Vienna Austria, April 22-26, 2015.
  13. Cavallin M, Kamath PS, Merli M, et al. Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial. Hepatology 2015; 62:567.
  14. Naggie S, Cooper C, Saag M, et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med 2015; 373:705.
  15. Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med 2015; 373:714.
  16. Sankaran SJ, Xiao AY, Wu LM, et al. Frequency of Progression From Acute to Chronic Pancreatitis and Risk Factors: A Meta-analysis. Gastroenterology 2015; 149:1490.
  17. Vege SS, Atwal T, Bi Y, et al. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology 2015; 149:318.
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  19. Lee CH, Steiner T, Petrof EO, et al. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA 2016; 315:142.
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  22. Bharucha AE, Parthasarathy G, Ditah I, et al. Temporal Trends in the Incidence and Natural History of Diverticulitis: A Population-Based Study. Am J Gastroenterol 2015; 110:1589.
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