Obscure Gastrointestinal Bleeding (Occult or Overt)
Conditions
Keywords
Capsule endoscopy, gastrointestinal hemorrhage
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.
Interventions
OTHERCapsule endoscopy
Capsule endoscopy
OTHERDedicated small bowel contrast radiography
Dedicated small bowel contrast radiography
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
Exclusion criteria
1. Known or suspected GI tract obstruction 2. Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction) 3. Pregnancy 4. Cardiac pacemaker or implanted electro-medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Further bleeding | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic yield | 1 year |
Countries
United States
Outcome results
None listed