The best investigation algorithm for patients with acute obscure gastrointestinal bleeding (OGIB) remains undefined. There are few randomized studies comparing the diagnostic yield of angiogram with CE in patients with active OGIB. Methods: This is a prospective randomized study that compared CE and angiogram in patients with acute OGIB. Consecutive patients presented with melena or hematochezia underwent upper and lower endoscopy within 24 hours of admission. Patients with non-diagnostic upper and lower endoscopy were randomized to undergo either CE or angiogram immediately. Small bowel Pillcam (GIVEN) was performed according to standard practice. A standardized protocol of 3-vessel visceral angiography was used. Patients who developed clinical rebleeding after negative initial investigation, defined as ongoing melena/hematochezia and drop in hemoglobin, were crossed-over to the other imaging modality. Exclusion criteria included moribund patients, patients with renal failure, presence of pacemaker, pregnancy, or those suspected to have intestinal obstruction. All patients were followed for 12-month for rebleeding. Gold standard for bleeding source was based on subsequent pathological findings if available or when this information was unavailable, lesions that most likely represented the source of bleeding. Diagnostic yield of the two modalities were compared. Results: Within an 18-month period, 41 patients with OGIB were randomized to CE or angiogram. Baseline characteristics of the two groups were comparable. The median follow up of two groups was 7.8 and 8.1 months, respectively. Eleven of 20 (55%) in the CE group and 2 of 21 (9.5%) in the angiogram yielded positive findings in their assigned examination (P = 0.003). In addition to small bowel lesions, CE detected gastric and duodenal ulcers that were not detected by initial EGD in 4 patients (20%). Three patients with negative angiographic findings had rebleeding during the same admission (2) or on follow-up (1) were crossed over to CE examinations, which showed definite bleeding source in the small bowel in two and in the proximal colon in the other. No patient in the CE group has rebleeding yet (P = 0.23). There was no adverse event related to both investigations. Surgery was performed in 4 patients (2 from each group) for resection of small bowel lesions (tumors and Meckel's diverticulum) diagnosed by the assigned investigation. One patient died of non-GI cause in the angiogram group. Conclusion: Results of this interim analysis suggest that CE is superior to angiogram as the immediate investigation for patients presented with active OGIB.
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