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

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.

Study Overview

• Status: Terminated
• Conditions: Obscure Gastrointestinal Bleeding
• Intervention / Treatment: Procedure: CAP

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No cap; enteroscopy performed without a cap	Procedure: CAP; CAP fitted to the end of the endoscope
Active Comparator: Enteroscopy with a cap; Enteroscopy performed with a CAP fitted to the end of the scope	Procedure: CAP; CAP fitted to the end of the endoscope

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Occult gastrointestinal bleeding; Obscure gastrointestinal bleeding; Overt gastrointestinal bleeding; Enteroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: SBE CAP 1