Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
John Robinson Saltzman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00593021
First received: December 28, 2007
Last updated: August 7, 2013
Last verified: August 2013

December 28, 2007
August 7, 2013
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
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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

Obscure Gastrointestinal Bleeding
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2009
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 information is only displayed when the study is recruiting subjects
United States
 
NCT00593021
SALTZMAN: 2007P-000991
No
John Robinson Saltzman, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: John R Saltzman, MD Brigham and Women's Hospital
Brigham and Women's Hospital
August 2013

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