Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Colorectal Cancer Clinical Trial

Official title:

Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01587872
• Other study ID #: SSK_DBC
• Status: Terminated
• Phase: N/A
• First received: January 12, 2012
• Last updated: April 11, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2012
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.

Description:

This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Failed cecal intubation during conventional colonoscopy due to technical difficulties

Exclusion Criteria:

• Failed cecal intubation due to insufficient bowel preparation

• Stenotic colonic lesions

• Patients decline

• Pregnancy

• Persons younger than 18 years

• Persons unable to comprehend the information given

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Adenomas
• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Procedure:
• Fujinon EC-450BI5 double-balloon colonoscope
Colonoscopy with the test instrument

Locations

Country	Name	City	State
Norway	Sorlandet Hospital HF	Kristiansand

Sponsors (3)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Fujifilm Europa, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (8)

Gay G, Delvaux M. Double-balloon colonoscopy after failed conventional colonoscopy: a pilot series with a new instrument. Endoscopy. 2007 Sep;39(9):788-92. — View Citation

Kaltenbach T, Soetikno R, Friedland S. Use of a double balloon enteroscope facilitates caecal intubation after incomplete colonoscopy with a standard colonoscope. Dig Liver Dis. 2006 Dec;38(12):921-5. Epub 2006 Sep 20. — View Citation

Mönkemüller K, Knippig C, Rickes S, Fry LC, Schulze A, Malfertheiner P. Usefulness of the double-balloon enteroscope in colonoscopies performed in patients with previously failed colonoscopy. Scand J Gastroenterol. 2007 Feb;42(2):277-8. — View Citation

Moreels TG, Macken EJ, Roth B, Van Outryve MJ, Pelckmans PA. Cecal intubation rate with the double-balloon endoscope after incomplete conventional colonoscopy: a study in 45 patients. J Gastroenterol Hepatol. 2010 Jan;25(1):80-3. doi: 10.1111/j.1440-1746.2009.05942.x. Epub 2009 Aug 3. — View Citation

Neerincx M, Terhaar sive Droste JS, Mulder CJ, Räkers M, Bartelsman JF, Loffeld RJ, Tuynman HA, Brohet RM, van der Hulst RW. Colonic work-up after incomplete colonoscopy: significant new findings during follow-up. Endoscopy. 2010 Sep;42(9):730-5. doi: 10.1055/s-0030-1255523. Epub 2010 Jul 28. — View Citation

Pasha SF, Harrison ME, Das A, Corrado CM, Arnell KN, Leighton JA. Utility of double-balloon colonoscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope. Gastrointest Endosc. 2007 May;65(6):848-53. Epub 2007 Feb 26. — View Citation

Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24. Erratum in: Am J Gastroenterol. 2009 Jun;104(6):1613. — View Citation

Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal intubation rate	The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.	2 hours	No
Secondary	Detection of additional colonic pathology	To assess if additional pathology is detected in segments of the colon reached with the test instrument that was not reached with a conventional colonoscope.	2 hours	No