Recurrent Gastrointestinal Bleeding Clinical Trial
Official title:
Comparative Effectiveness of Wireless Capsule Endoscopy and Dual Energy, Phase CT Enterography in the Evaluation of Overt Obscure GI Bleeding
| Verified date | August 2013 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by
upper endoscopy 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.
Obscure gastrointestinal bleeding (OGIB) refers to bleeding undiagnosed by upper endoscopy
and colonoscopy. In 40-70% of cases of OGIB, a bleeding lesion is localizable to the small
bowel. In OGIB, capsule endoscopy (CE) has a diagnostic yield of 40-80%, and has
demonstrated diagnostic superiority to push enteroscopy, barium studies, angiography, CT
angiography, and routine abdominal CT scan. When CE is non-diagnostic, however, the
subsequent diagnostic algorithm is not well-defined. There is currently no established role
for cross-sectional imaging for this indication. CT enterography (CTE) combines the spatial
and temporal resolution of CT with an orally administered neutral enteric contrast material
that permits detailed visualization of the small bowel. Unlike other imaging modalities such
as nuclear medicine techniques and catheter angiography, CT is less labor-intensive, more
readily available, and provides precise anatomic localization. A novel OGIB-protocol
available at Brigham and Women's Hospital for CTE utilizes a dual-phase, dual energy
technique that obtains images at two time points to better identify active bleeding in the
mesentery. We, the investigators, plan to prospectively study an algorithm that employs CTE
and compare to capsule endoscopy to investigate the effectiveness of both modalities and to
evaluate the potential role of CTE in OGIB.
The goal of our study is to determine observationally the contribution of both CE and the
new protocol for CTE to the evaluation and management of overt obscure GI bleeding and
accordingly revise the clinical algorithm.
We hypothesize that CTE will be as or more effective than CE at identifying culprit lesions
in overt, obscure gastrointestinal bleeding.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2012 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients presenting with signs and symptoms of "overt, obscure GI bleeding" including hematemesis, melena, and hematochezia within the past 14 days with negative endoscopic evaluation (including upper endoscopy for hematemesis, and both upper and lower endoscopy for hematochezia) despite clinical evidence of GI bleeding. Exclusion Criteria: - Known renal insufficiency (or blood Creat >1.5 or estimated glomerular filtration rate [eGFR]<60) - Allergy to iodinated intravenous (IV) contrast media - Swallowing difficulties - Known small bowel strictures - Suspected bowel obstruction - Under the age of 18 - Unable to give consent - Currently pregnant |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms. | Patients enrolled in the study will undergo either capsule endoscopy or CT enterography first, and this decision will generally be based on which test the clinical providers have already scheduled or availability of testing as is done with routine clinical care. The results of each the test will be read by an experienced gastroenterologist or radiologist respectively. These reviewers will be blinded to the results of any other diagnostic studies. The patient will then undergo the second test. | 2-3 days | No |
| Secondary | Contribution of diagnostic test to clinical management | We will assess whether either CT or CTE changes managemet based on findings | 30 days | No |
| Secondary | Overall cost of evaluation | We will assess the cost of each test and cost based on findings | 30 days | No |
| Secondary | Adverse events | We will measure any and all adverse outcomes based on CT or CTE for the month following whichever study is performed last. | 30 days | No |