Background & aims: Capsule endoscopy improves the diagnostic yield in patients with obscure gastrointestinal (GI) bleeding, but whether it improves outcomes is uncertain.
Methods: Patients with obscure GI bleeding and negative upper endoscopy, colonoscopy, and push enteroscopy were randomly assigned to capsule endoscopy or dedicated small bowel contrast radiography. Patients returned at 1, 2, 3, 6, 9, and 12 months for follow-up visits and to check hemoglobin level. The primary endpoint was further bleeding.
Results: The predefined sample size of 136 patients (54 overt bleeding, 82 occult bleeding) was enrolled. Diagnostic yield was 20 (30%) with capsule vs 5 (7%) with radiography (difference = 23%; 95% CI: 11%-36%). Further bleeding with capsule versus radiography occurred in 20 (30%) versus 17 (24%) (difference, 6%; 95% confidence interval [CI], -9% to 21%), subsequent diagnostic or therapeutic interventions for bleeding were performed in 17 (26%) versus 15 (21%) (difference, 4%; 95% CI, -10% to 19%), subsequent hospitalizations for bleeding were required in 8 (12%) versus 4 (6%) (difference, 6%; 95% CI, -3% to 16%), and subsequent blood transfusions were given in 5 (8%) versus 4 (6%) (difference, 2%; 95% CI, -7% to 10%). Further bleeding was more common in patients presenting with overt bleeding than in those with occult bleeding (21/54 [39%] vs 16/82 [20%]; difference, 19%; 95% CI, 4% to 35%).
Conclusions: The significant improvement in diagnostic yield with capsule endoscopy may not translate into improved outcomes in a population with obscure GI bleeding. Most patients do well whether or not abnormalities are identified, and additional diagnostic or therapeutic interventions may be required whether or not capsule endoscopy identifies a source of bleeding.
Trial registration: ClinicalTrials.gov NCT01006824.
Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.