Comparative Effectiveness of Wireless Capsule Endoscopy and Dual Energy, Phase CT Enterography in the Evaluation of Overt Obscure GI Bleeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Primary Endpoint
- Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Overt Obscure Gastrointestinal Bleeders
The only cohort in this study are those patients identified as having overt, obscure gastrointestinal bleeding who will then undergo CE or CTE.
Intervention: Capsule Endoscopy (Device)
Overt Obscure Gastrointestinal Bleeders
The only cohort in this study are those patients identified as having overt, obscure gastrointestinal bleeding who will then undergo CE or CTE.
Intervention: CT Enterography (Radiation)
Outcomes
Primary Outcomes
Detection of an actively bleeding lesion or lesion believed to be causing bleeding symptoms.
Time Frame: 2-3 days
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.
Secondary Outcomes
- Contribution of diagnostic test to clinical management(30 days)
- Overall cost of evaluation(30 days)
- Adverse events(30 days)
Investigators
John Robinson Saltzman, MD
Director of Endoscopy
Brigham and Women's Hospital