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

NCT ID: NCT02315404

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-05-31

Brief Summary

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.

Conditions

Obscure Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

No cap

enteroscopy performed without a cap

Group Type: PLACEBO_COMPARATOR

CAP

Intervention Type: PROCEDURE

CAP fitted to the end of the endoscope

Enteroscopy with a cap

Enteroscopy performed with a CAP fitted to the end of the scope

Group Type: ACTIVE_COMPARATOR

CAP

Intervention Type: PROCEDURE

CAP fitted to the end of the endoscope

Interventions

CAP

CAP fitted to the end of the endoscope

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University in St Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

SBE CAP 1

Identifier Type: -

Identifier Source: org_study_id