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

NCT ID: NCT01184690

Last Updated: 2010-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Small-Bowel Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Single-operator DBE

Single-operator double-balloon endoscopy

Group Type ACTIVE_COMPARATOR

Single-operator double-balloon endoscopy

Intervention Type PROCEDURE

Single-operator double-balloon endoscopy

Dual-operator DBE

Dual-operator double-balloon endoscopy

Group Type ACTIVE_COMPARATOR

dual-operator double-balloon endoscopy

Intervention Type PROCEDURE

dual-operator double-balloon endoscopy

Interventions

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Single-operator double-balloon endoscopy

Single-operator double-balloon endoscopy

Intervention Type PROCEDURE

dual-operator double-balloon endoscopy

dual-operator double-balloon endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Changzheng Hospital

Principal Investigators

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Jian Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Bin Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Wei-Fen Xie, MD

Role: STUDY_DIRECTOR

Shanghai Changzheng Hospital

Locations

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Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.

Reference Type RESULT
PMID: 18819060 (View on PubMed)

Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Yoshioka S, Yoshioka A, Kanai T, Watanabe M. Single-operator double-balloon endoscopy (DBE) is as effective as dual-operator DBE. J Gastroenterol Hepatol. 2009 May;24(5):770-5. doi: 10.1111/j.1440-1746.2009.05787.x. Epub 2009 Feb 12.

Reference Type RESULT
PMID: 19220668 (View on PubMed)

Other Identifiers

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DBE-S vs D

Identifier Type: -

Identifier Source: org_study_id

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