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

Small-Bowel Disorders Clinical Trial

— DBE;SBE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01176864
• Other study ID #: ERK-2
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: August 5, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2010
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Diseases
• Small-Bowel Disorders

Intervention

Procedure:
• Double-balloon enteroscopy
Double-balloon enteroscopy
• Single-balloon enteroscopy
Single-balloon enteroscopy

Locations

Country	Name	City	State
China	Shanghai changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Frantz DJ, Dellon ES, Grimm IS, Morgan DR. Single-balloon enteroscopy: results from an initial experience at a U.S. tertiary-care center. Gastrointest Endosc. 2010 Aug;72(2):422-6. doi: 10.1016/j.gie.2010.03.1117. Epub 2010 Jun 11. — View Citation

May A, Färber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Möschler O, Kunz J, Gossner L, Mönkemüller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whether the complete enteroscopy is achieved?	the rate of complete enteroscopy in both groups.	2 hours	No
Secondary	Preparation time		2 hours	No
Secondary	Investigation time		2 hours	No
Secondary	side effects		2 days	Yes
Secondary	Diagnostic yield		2 hours	No