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This study has been withdrawn prior to enrollment.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
  Purpose

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
Obscure Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital course, clinical improvement [ Time Frame: 120 days from enrollment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593021

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

No publications provided

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
Study First Received: December 28, 2007
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Obscure Gastrointestinal Bleeding
Occult Gastrointestinal Bleeding
Overt Gastrointestinal Bleeding
Capsule Endoscopy
CT Enterography

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

ClinicalTrials.gov processed this record on July 23, 2014