Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding

Study Overview
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Brief Summary
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Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding

Detailed Description
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Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work. Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.

Official Title
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Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding

Conditions
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Small-Bowel Disorders

Intervention / Treatment
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* Procedure: Double-balloon enteroscopy
* Procedure: Single-balloon enteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspected or known small-bowel bleeding age: 16-70 Exclusion Criteria: pregnancy coagulation disorders prior surgery of the small bowel and colon

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double-balloon enteroscopy<br>DBE for suspected or known small-bowel bleeding | Procedure: Double-balloon enteroscopy<br>* Double-balloon enteroscopy<br>|
| Active Comparator: Single-balloon enteroscopy<br>SBE for suspected or known small-bowel bleeding | Procedure: Single-balloon enteroscopy<br>* Single-balloon enteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether the complete enteroscopy is achieved? | the rate of complete enteroscopy in both groups. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparation time |  | 2 hours | 
| Investigation time |  | 2 hours | 
| side effects |  | 2 days | 
| Diagnostic yield |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy