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

Small-Bowel Disorders Clinical Trial

— DBE  

Official title:

Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01184690
• Other study ID #: DBE-S vs D
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: August 16, 2010
• Last updated: August 18, 2010
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2010
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Diseases
• Small-Bowel Disorders

Intervention

Procedure:
• Single-operator double-balloon endoscopy
Single-operator double-balloon endoscopy
• dual-operator double-balloon endoscopy
dual-operator double-balloon endoscopy

Locations

Country	Name	City	State
China	Shanghai changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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.1440-1746.200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completion whether the complete enteroscopy is achieved?	The completion rate for examination of the entire small intestine	2 hours	No
Primary	lesion-discovery	lesion-discovery rate	2 hours	No
Secondary	observation time		2 hours	No
Secondary	Number of Participants with Adverse Events		2 days	Yes