Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Inflammatory Bowel Disease; Colorectal Adenomas
• Intervention / Treatment: Procedure: Fujinon EC-450BI5 double-balloon colonoscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansand, Norway, 4604
    • Sorlandet Hospital HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DBC; Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments.	Procedure: Fujinon EC-450BI5 double-balloon colonoscope; Colonoscopy with the test instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: South-Eastern Norway Regional Health Authority; Fujifilm Europa
• Investigators: Study Chair: Michael Bretthauer, PhD, The Cancer Registry of Norway, Oslo University Hospital; Principal Investigator: Kjetil K Garborg, MD, Sorlandet Hospital HF, Kristiansand, Norway

Publications and helpful links

General Publications

• 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.
• Neerincx M, Terhaar sive Droste JS, Mulder CJ, Rakers 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.
• Yamamoto H, Kita H. Enteroscopy. J Gastroenterol. 2005 Jun;40(6):555-62. doi: 10.1007/s00535-005-1645-5.
• 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.
• Monkemuller 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. doi: 10.1080/00365520600802785. No abstract available.
• 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. doi: 10.1016/j.gie.2006.08.046. Epub 2007 Feb 26.
• 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. doi: 10.1016/j.dld.2006.08.003. Epub 2006 Sep 20.
• 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. doi: 10.1055/s-2007-966753.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (ESTIMATE): April 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 11, 2014
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Screening colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Adenoma
• Other Study ID Numbers: SSK_DBC