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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00593021
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 14, 2008
Last Update Posted : August 9, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Obscure Gastrointestinal Bleeding

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Study Start Date : October 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding [ Time Frame: Continuous ]

Secondary Outcome Measures :
  1. Hospital course, clinical improvement [ Time Frame: 120 days from enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593021

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: John R Saltzman, MD Brigham and Women's Hospital
More Information

Responsible Party: John Robinson Saltzman, MD, Director of Endoscopy, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00593021     History of Changes
Other Study ID Numbers: SALTZMAN: 2007P-000991
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by John Robinson Saltzman, MD, Brigham and Women's Hospital:
Obscure Gastrointestinal Bleeding
Occult Gastrointestinal Bleeding
Overt Gastrointestinal Bleeding
Capsule Endoscopy
CT Enterography

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases