Chapter 4-06: Key Clinical Trials and Publications in Gastroenterology

GI BLEED

• Transfusion Strategies for Acute Upper Gastrointestinal Bleeding. N Engl J Med 2013;368:11–21.

  • - Randomized controlled trial that randomized 921 patients with severe acute UGIB to a restrictive transfusion strategy (transfuse for Hgb <7 g/dL) or a liberal transfusion strategy (transfuse for Hgb <9 g/dL). The restrictive strategy reduced further bleeding, and a subgroup analysis revealed improved survival with the restrictive strategy for patients with cirrhosis and Child-Pugh A or B disease (but not Class C). Of note, exclusion criteria included massive exsanguinating bleeding, ACS, CVA/TIA, recent trauma/surgery, or LGIB.

• COGENT. N Engl J Med 2010;363:1909–1917.

  • - Double-blind, randomized controlled trial that randomized patients on clopidogrel and aspirin to receive omeprazole vs. placebo. Prophylactic PPI reduced the rate of upper GI bleed.

BARRETT’S ESOPHAGUS

• Radiofrequency Ablation in Barrett’s Esophagus with Dysplasia. N Engl J Med 2009;360:2277–2288.

  • - Sham-controlled randomized controlled trial assessing whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett’s esophagus and decrease the rate of neoplastic progression. RFA had a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression.

PANCREATITIS

• Compared with Parenteral Nutrition, Enteral Feeding Attenuates the Acute Phase Response and Improves Disease Severity in Acute Pancreatitis. Gut 1998;42:431–435.

  • - Randomized controlled trial comparing TPN vs. enteral nutrition in patients with acute pancreatitis. Enteral nutrition improved disease severity and clinical outcomes.

DIVERTICULITIS

• AVOD. Br J Surg 2012;99:532–539.

  • - Nonblinded, placebo-controlled, randomized controlled trial comparing antibiotic vs. placebo for treatment of acute uncomplicated diverticulitis. Antibiotic treatment did not accelerate recovery or prevent complications or recurrence.

CHOLECYSTECTOMY

• ACDC. Ann Surg 2013;258:385–393.

  • - Parallel-group, open-label, randomized controlled trial comparing early laparoscopic cholecystectomy (<24 hours) versus initial antibiotics and delayed surgery (7–45 days). Early surgery had lower morbidity and healthcare costs.

IBD

• SONIC. N Engl J Med 2010;362:1383–1395.

  • - Double-blind randomized controlled trial assessing the safety and efficacy of infliximab and azathioprine alone or in combination for patients with Crohn’s disease. Combination therapy or infliximab monotherapy were more likely to have steroid-free remission than azathioprine monotherapy.

FUNCTIONAL BOWEL DISORDERS

• Cognitive-Behavioral Therapy Versus Education and Desipramine Versus Placebo for Moderate to Severe Functional Bowel Disorders. Gastroenterology 2003;125:19–31.

  • - Randomized controlled trial comparing CBT versus education and desipramine (TCA) versus placebo in treatment of female patients with functional bowel disorders (IBS, functional abdominal pain, constipation). CBT is effective and desipramine is effective when taken adequately and in certain clinical subgroups.

ALCOHOLIC HEPATITIS

• STOPAH. N Engl J Med 2015;372(17):1619–1628.

  • - Prospective multicenter randomized, double-blind trial in 65 hospitals in the UK comparing the use of prednisone, pentoxifylline, combination prednisone-pentoxifylline, or placebo in patients with severe alcoholic hepatitis. Neither prednisolone nor pentoxifylline ...