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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT01176864
First received: July 28, 2010
Last updated: August 5, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Small-Bowel Disorders
 Procedure: Double-balloon enteroscopy
Procedure: Single-balloon enteroscopy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding

Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    the rate of complete enteroscopy in both groups.


Secondary Outcome Measures:
  • Preparation time [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Investigation time [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Diagnostic yield [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Double-balloon enteroscopy
DBE for suspected or known small-bowel bleeding
 Procedure: Double-balloon enteroscopy
Double-balloon enteroscopy
Active Comparator: Single-balloon enteroscopy
SBE for suspected or known small-bowel bleeding
 Procedure: Single-balloon enteroscopy
Single-balloon enteroscopy

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

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176864

Locations
China, Shanghai
Shanghai changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
Principal Investigator: Jian Shi, MD Shanghai Changzheng Hospital
Principal Investigator: Bin Shi, MD Shanghai Changzheng Hospital
Study Director: Wei-Fen Xie, MD Shanghai Changzheng Hospital
  More Information

Publications:

Responsible Party: Jian Shi, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT01176864     History of Changes
Other Study ID Numbers: ERK-2
Study First Received: July 28, 2010
Last Updated: August 5, 2010
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Changzheng Hospital:
Small-Bowel Disorders
Double-balloon enteroscopy
Single-balloon enteroscopy

Additional relevant MeSH terms:
Hemorrhage
Intestinal Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013