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

August 5, 2010 updated by: Shanghai Changzheng Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Shanghai Changzheng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
whether the complete enteroscopy is achieved?
Time Frame: 2 hours
the rate of complete enteroscopy in both groups.
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Preparation time
Time Frame: 2 hours
2 hours
Investigation time
Time Frame: 2 hours
2 hours
side effects
Time Frame: 2 days
2 days
Diagnostic yield
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERK-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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