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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014