Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

Completed

• Conditions: Obscure Gastrointestinal Bleeding

• Registration Number: NCT01625585
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The goal of the present study is to investigate the clinical outcomes of patients with gastrointestinal bleeding originating from the small intestine following diagnostic investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients with gastrointestinal bleeding originating in the small intestine.

Detailed Description

The small intestine has been, until recent years, a black box to gastroenterologists because it is difficult to see and reach. Radiological imaging provides little details of small intestinal mucosa. Capsule endoscopy, introduced in 2001, enables gastroenterologists to visualize the entire small intestine from within for the first time, but it is only a diagnostic tool. Single-balloon enteroscopy (SBE) is a new enteroscopy methods that use an overtube with one balloon or a spiral to help pleat bowel onto the endoscope and allow examination of the distal small bowel. This methods allow for biopsy, hemostasis, and other therapeutic interventions to be performed in the small bowel. Early reports have been promising; with 50-70% diagnostic yield for small bowel pathology reported in the literature. However, despite these promising results the impact SBE findings on patient outcomes is not clear.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-03
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Patients with Obscure Gastrointestinal Bleeding undergoing SBE at Barnes Jewish Hospital

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Exclusion Criteria

• Less than 3 months of follow up after SBE
• The endoscope could not be advanced into the duodenum will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy	4 years	The primary outcome is recurrence of gastrointestinal bleeding, defined as recurrent overt or occult gastrointestinal bleeding, hospitalization for gastrointestinal bleeding or acute blood loss anemia.

Trial Locations

Locations (1)

Barnes Jewish Hospital/ Washington University; 🇺🇸 St Louis, Missouri, United States