Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

Phase 4

Completed

• Conditions: Obscure Gastrointestinal Bleeding (Occult or Overt)
• Interventions: Other: Capsule endoscopy; Other: Dedicated small bowel contrast radiography

• Registration Number: NCT01006824
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Capsule endoscopy	Capsule Endoscopy
2	Dedicated small bowel contrast radiography	Dedicated small bowel contrast radiography

Primary Outcome Measures

Name	Time	Method
Further bleeding	1 year

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield	1 year

Trial Locations

Locations (1)

L.A. County + U.S.C. Medical Center; 🇺🇸 Los Angeles, California, United States