Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Further bleeding
Study Overview
Brief Summary
This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.
The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
- •Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
Exclusion Criteria
- •Known or suspected GI tract obstruction
- •Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction)
- •Cardiac pacemaker or implanted electro-medical devices
Arms & Interventions
1
Capsule Endoscopy
Intervention: Capsule endoscopy (Other)
2
Dedicated small bowel contrast radiography
Intervention: Dedicated small bowel contrast radiography (Other)
Outcomes
Primary Outcomes
Further bleeding
Time Frame: 1 year
Secondary Outcomes
- Diagnostic yield(1 year)