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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

NCT ID: NCT00593021

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obscure Gastrointestinal Bleeding

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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John Robinson Saltzman, MD

Director of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John R Saltzman, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SALTZMAN: 2007P-000991

Identifier Type: -

Identifier Source: org_study_id