Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Recruitment status was Recruiting
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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 |
- Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- Hospital course, clinical improvement [ Time Frame: 120 days from enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated 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 |
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| 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, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jaya R Agrawal, MD, MPH 617-525-8763 jagrawal@partners.org | |
| Contact: John R Saltzman, MD 617-525-8763 jsaltzman@partners.org | |
| Sub-Investigator: Jaya R Agrawal, MD, MPH | |
| Principal Investigator: John R Saltzman, MD | |
| Sub-Investigator: Anne T Wolf, MD, MSc | |
| Sub-Investigator: Sarathchandra I Reddy, MD | |
| Sub-Investigator: Koenrad J Mortele, MD | |
| Sub-Investigator: Stuart G Silverman, MD | |
| Sub-Investigator: Rie Maurer, MA | |
| Principal Investigator: | John R Saltzman, MD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | John R. Saltzman, MD, 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: | May 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General 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 May 19, 2013