Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Locations
- 1
- Primary Endpoint
- Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding
Study Overview
Brief Summary
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy
Exclusion Criteria
- •Under the age of 18
- •Unable to give consent
- •IV Contrast Allergy (excluded from CT)
- •Renal insufficiency (excluded from CT)
- •Unable to swallow (excluded from capsule)
- •Small bowel obstruction or stricturing disease (excluded from capsule)
Outcomes
Primary Outcomes
Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding
Time Frame: Continuous
Secondary Outcomes
- Hospital course, clinical improvement(120 days from enrollment)
Investigators
John Robinson Saltzman, MD
Director of Endoscopy
Brigham and Women's Hospital
