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
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic