- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593021
Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
August 7, 2013 updated by: John Robinson Saltzman, MD, Brigham and Women's Hospital
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding
Time Frame: Continuous
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Continuous
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital course, clinical improvement
Time Frame: 120 days from enrollment
|
120 days from enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R Saltzman, MD, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
December 28, 2007
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SALTZMAN: 2007P-000991
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obscure Gastrointestinal Bleeding
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Washington University School of MedicineTerminatedObscure Gastrointestinal BleedingUnited States
-
University of Southern CaliforniaCompletedObscure Gastrointestinal Bleeding (Occult or Overt)United States
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King Chulalongkorn Memorial HospitalCompletedOvert Obscure Gastrointestinal BleedingThailand
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Centro Hospitalar de Vila Nova de Gaia/Espinho,...RecruitingObscure Gastrointestinal BleedingPortugal
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University of CalgaryAlberta Heritage Foundation for Medical Research; Calgary Health RegionCompleted
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Washington University School of MedicineCompletedObscure Gastrointestinal BleedingUnited States
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Unity Health TorontoActive, not recruitingGastrointestinal Diseases | Obscure Gastrointestinal Bleeding | Gastrointestinal Bleed | Angiodysplasia IntestineCanada
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Fondazione Poliambulanza Istituto OspedalieroHospices Civils de Lyon; Fondazione Policlinico Universitario Agostino Gemelli... and other collaboratorsCompletedIron Deficiency Anemia | Obscure Gastrointestinal BleedingItaly
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Texas Tech University Health Sciences Center, El...RecruitingAnemia, Iron Deficiency | Obscure Gastrointestinal BleedingUnited States
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Shanghai Jiao Tong University School of MedicineCompletedGastric Antral Vascular Ectasia | Angiodysplasia | Obscure Gastrointestinal Bleeding | Thalidomide