Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Obscure Gastrointestinal Bleeding Clinical Trial

Official title:

Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00593021
• Other study ID #: SALTZMAN: 2007P-000991
• Status: Withdrawn
• Phase: N/A
• First received: December 28, 2007
• Last updated: August 7, 2013
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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:

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Obscure Gastrointestinal Bleeding

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding		Continuous	No
Secondary	Hospital course, clinical improvement		120 days from enrollment	No