Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel. The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.

Official Title
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Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

Conditions
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Obscure Gastrointestinal Bleeding

Intervention / Treatment
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* Procedure: CAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia. Exclusion Criteria: Unable to provide written informed consent. Pregnancy or lactation. Suspected bowel obstruction or GI perforation. Unable to tolerate sedation or general anesthesia due to medical co-morbidities. Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal). Patient undergoing retrograde BAE.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No cap<br>enteroscopy performed without a cap | Procedure: CAP<br>* CAP fitted to the end of the endoscope<br>|
| Active Comparator: Enteroscopy with a cap<br>Enteroscopy performed with a CAP fitted to the end of the scope | Procedure: CAP<br>* CAP fitted to the end of the endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE). | Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified. a. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Diagnostic yield of BAE vs. C-BAE | Diagnostic yield defined as proportion of enteroscopies in which any abnormality is detected. a. Abnormalities classified as: i. P0: lesion with no bleeding potential, including visible submucosal veins, diverticula without the presence of blood or nodules without mucosal break. ii. P1: lesion considered as having uncertain bleeding potential, such as a red spot on the intestinal mucosa or small erosions. iii. P2: lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices | 1 day | 
| Therapeutic yield BAE vs. Cap assisted BAE (C-BAE). | Therapeutic yield being defined as proportion of enteroscopies in which a therapeutic intervention was undertaken. Interventions included in this calculation were polypectomy, argon plasma coagulation, bipolar coagulation, dilation of strictures, and endoscopic clipping. Biopsy was considered to be a therapeutic intervention if histopathology results lead to the initiation of a medical or surgical therapy (i.e: resection of mass, medical therapy for Crohn's disease) | 1 day | 
| iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al. | Fold counting method: The number of complete folds (valvulae conniventes) will be counted during withdrawal of the endoscope; with the assumption that the distance between folds is approximately 0.9 cm. | 1 day | 
| vProcedure related adverse events. |  | 1 day | 
| Recurrence of GI bleeding at 12 months, as evaluated by questionnaire |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obscure gastrointestinal bleeding, Overt gastrointestinal bleeding, Occult gastrointestinal bleeding, Enteroscopy