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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176864

Acronym

DBE;SBE

Enrollment

100

Registered

2010-08-06

Start date

2010-07-31

Completion date

2012-07-31

Last updated

2010-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small-Bowel Disorders

Keywords

Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy

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.

Interventions

PROCEDUREDouble-balloon enteroscopy

Double-balloon enteroscopy

PROCEDURESingle-balloon enteroscopy

Single-balloon enteroscopy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
whether the complete enteroscopy is achieved?	2 hours	the rate of complete enteroscopy in both groups.

Secondary

Measure	Time frame
side effects	2 days
Diagnostic yield	2 hours
Preparation time	2 hours
Investigation time	2 hours

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026