Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders (DBE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT01184690
First received: August 16, 2010
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.


Condition Intervention Phase
Small-Bowel Disorders
Procedure: Single-operator double-balloon endoscopy
Procedure: dual-operator double-balloon endoscopy
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 Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

Resource links provided by NLM:


Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • completion whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The completion rate for examination of the entire small intestine

  • lesion-discovery [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    lesion-discovery rate


Secondary Outcome Measures:
  • observation time [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single-operator DBE
Single-operator double-balloon endoscopy
Procedure: Single-operator double-balloon endoscopy
Single-operator double-balloon endoscopy
Active Comparator: Dual-operator DBE
Dual-operator double-balloon endoscopy
Procedure: dual-operator double-balloon endoscopy
dual-operator double-balloon endoscopy

  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 disease
  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: NCT01184690

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: NCT01184690     History of Changes
Other Study ID Numbers: DBE-S vs D
Study First Received: August 16, 2010
Last Updated: August 18, 2010
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Changzheng Hospital:
double-balloon endoscopy
diagnostic yield

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014