Clinical trial NCT01176864: Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding
Official title: Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Small-Bowel Disorders
Keywords: Small-Bowel Disorders
Double-balloon enteroscopy
Single-balloon enteroscopy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: whether the complete enteroscopy is achieved?
timeFrame: 2 hours
Secondary outcomes:
measure: Preparation time
timeFrame: 2 hours
measure: Investigation time
timeFrame: 2 hours
measure: side effects
timeFrame: 2 days
measure: Diagnostic yield
timeFrame: 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jian Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Bin Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Wei-Fen Xie, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: May A, Farber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Moschler O, Kunz J, Gossner L, Monkemuller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders. Am J Gastroenterol. 2010 Mar;105(3):575-81. doi: 10.1038/ajg.2009.712. Epub 2010 Jan 5.