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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
This study is currently recruiting participants.
Study NCT00593021   Information provided by Massachusetts General Hospital
First Received: December 28, 2007   Last Updated: September 28, 2009   History of Changes

December 28, 2007
September 28, 2009
October 2007
September 2009   (final data collection date for primary outcome measure)
Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding [ Time Frame: Continuous ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00593021 on ClinicalTrials.gov Archive Site
Hospital course, clinical improvement [ Time Frame: 120 days from enrollment ] [ Designated as safety issue: No ]
Same as current
 
Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

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.

 
 
Observational
Case-Only, Prospective
Obscure Gastrointestinal Bleeding
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
December 2010
September 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Jaya R Agrawal, MD, MPH 617-525-8763 jagrawal@partners.org
Contact: John R Saltzman, MD 617-525-8763 jsaltzman@partners.org
United States
 
NCT00593021
John R. Saltzman, MD, Brigham and Women's Hospital
SALTZMAN: 2007P-000991
Massachusetts General Hospital
 
Principal Investigator: John R Saltzman, MD Brigham and Women's Hospital
Massachusetts General Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP