Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding (DBE;SBE)

Naval Military Medical University (Second Military Medical University)

Status and phase: Unknown; Phase 4

Conditions: Small-Bowel Disorders

Treatments: Procedure: Double-balloon enteroscopy; Procedure: Single-balloon enteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01176864

ERK-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Double-balloon enteroscopy

Active Comparator group

Description:

DBE for suspected or known small-bowel bleeding

Treatment:

Procedure: Double-balloon enteroscopy

Single-balloon enteroscopy

Active Comparator group

Description:

SBE for suspected or known small-bowel bleeding

Treatment:

Procedure: Single-balloon enteroscopy