A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to non-hematemesis gastrointestinal bleeding (with videos)

OBJECTIVE: Patients presenting with non-hematemesis GI bleeding represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. DESIGN: Patients admitted with non-hematemesis GI bleeding were randomized and placed into one of 2 study groups. In the experimental group patients ingested a video capsule soon after admission to the hospital. These capsule patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist\u27s interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. RESULTS: Eighty-seven patients were included in this study, 45 were randomized to the Standard of Care arm and 42 were randomized to the Early Capsule arm. A bleeding source was localized in 64.3% of the patients in the Early Capsule arm and in 31.1% of the patients in the Standard of Care arm (p \u3c 0.01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36 - 5.64). CONCLUSION: For patients admitted to the hospital for non-hematemesis GI bleeding, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding