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

Obscure Gastrointestinal Bleeding (Occult or Overt) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006824
• Other study ID #: HS-02C010
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2009
• Last updated: January 24, 2011
• Start date: March 2003
• Est. completion date: September 2009

Study information

• Verified date: January 2011
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Obscure Gastrointestinal Bleeding (Occult or Overt)

Intervention

Other:
• Capsule endoscopy
Capsule endoscopy
• Dedicated small bowel contrast radiography
Dedicated small bowel contrast radiography

Locations

Country	Name	City	State
United States	L.A. County + U.S.C. Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (1)

Laine L, Sahota A, Shah A. Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Gastroenterology. 2010 May;138(5):1673-1680.e1; quiz e11-2. doi: 10.1053/j.gastro.2010.01.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Further bleeding		1 year	No
Secondary	Diagnostic yield		1 year	No