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

Phase 4

• Conditions: Small-Bowel Disorders
• Interventions: Procedure: Double-balloon enteroscopy; Procedure: Single-balloon enteroscopy

• Registration Number: NCT01176864
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-08-05
• Last Update Submitted: 2010-08-05
• Study First Posted: 2010-08-06
• Last Update Posted: 2010-08-06
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. suspected or known small-bowel bleeding
2. age: 16-70

Exclusion Criteria

1. pregnancy
2. coagulation disorders
3. prior surgery of the small bowel and colon

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double-balloon enteroscopy	Double-balloon enteroscopy	DBE for suspected or known small-bowel bleeding
Single-balloon enteroscopy	Single-balloon enteroscopy	SBE for suspected or known small-bowel bleeding

Primary Outcome Measures

Name	Time	Method
whether the complete enteroscopy is achieved?	2 hours	the rate of complete enteroscopy in both groups.

Secondary Outcome Measures

Name	Time	Method
Preparation time	2 hours
Investigation time	2 hours
side effects	2 days
Diagnostic yield	2 hours

Trial Locations

Locations (1)

Shanghai changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China