Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

NCT00593021 | Withdrawn

• 1 other identifier: SALTZMAN: 2007P-000991
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obscure Gastrointestinal Bleeding

Keywords

Obscure Gastrointestinal Bleeding; Occult Gastrointestinal Bleeding; Overt Gastrointestinal Bleeding; Capsule Endoscopy; CT Enterography

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding

  Continuous

Secondary Outcomes (1)

• Hospital course, clinical improvement

  120 days from enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults over the age of 18 and able to give consent who are referred to the Brigham and Women's Hospital Endoscopy Center or GI Clinic for the evaluation of obscure gastrointestinal bleeding

You may qualify if:

• Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• John R Saltzman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)