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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

July 28, 2010
August 5, 2010
July 2010
July 2012   (final data collection date for primary outcome measure)
whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
the rate of complete enteroscopy in both groups.
Same as current
Complete list of historical versions of study NCT01176864 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Small-Bowel Disorders
  • Procedure: Double-balloon enteroscopy
    Double-balloon enteroscopy
  • Procedure: Single-balloon enteroscopy
    Single-balloon enteroscopy
  • Active Comparator: Double-balloon enteroscopy
    DBE for suspected or known small-bowel bleeding
    Intervention: Procedure: Double-balloon enteroscopy
  • Active Comparator: Single-balloon enteroscopy
    SBE for suspected or known small-bowel bleeding
    Intervention: Procedure: Single-balloon enteroscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01176864
ERK-2
Yes
Jian Shi, Shanghai Changzheng Hospital
Shanghai Changzheng Hospital
Not Provided
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
Shanghai Changzheng Hospital
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP