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

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ClinicalTrials.gov Identifier: NCT01184690
Recruitment Status : Unknown
Verified August 2010 by Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
Sponsor:
Information provided by:
Shanghai Changzheng Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Small-Bowel Disorders Procedure: Single-operator double-balloon endoscopy Procedure: dual-operator double-balloon endoscopy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. completion whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ]
    The completion rate for examination of the entire small intestine

  2. lesion-discovery [ Time Frame: 2 hours ]
    lesion-discovery rate


Secondary Outcome Measures :
  1. observation time [ Time Frame: 2 hours ]
  2. Number of Participants with Adverse Events [ Time Frame: 2 days ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01184690


Locations
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China, Shanghai
Shanghai changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
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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
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Publications of Results:

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Responsible Party: Jian Shi, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT01184690    
Other Study ID Numbers: DBE-S vs D
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 2010
Keywords provided by Shanghai Changzheng Hospital:
double-balloon endoscopy
diagnostic yield
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases