Skip to main content
Clinical Trials/NCT00593021
NCT00593021WithdrawnNot Applicable

Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Brigham and Women's Hospital1 site in 1 countryStarted: October 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Robinson Saltzman, MD

Director of Endoscopy

Brigham and Women's Hospital

Study Sites (1)

Loading locations...

Similar Trials

Diagnostic Evaluation of Obscure... | Clinical Trial