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

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ClinicalTrials.gov Identifier: NCT01176864
Recruitment Status : Unknown
Verified July 2010 by Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 6, 2010
Last Update Posted : August 6, 2010
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Small-Bowel Disorders Procedure: Double-balloon enteroscopy Procedure: Single-balloon enteroscopy Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ]
    the rate of complete enteroscopy in both groups.


Secondary Outcome Measures :
  1. Preparation time [ Time Frame: 2 hours ]
  2. Investigation time [ Time Frame: 2 hours ]
  3. side effects [ Time Frame: 2 days ]
  4. Diagnostic yield [ Time Frame: 2 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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