Cap Assisted Colonoscopy for the Detection of Colon Polyps

Colon Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01211132
• Other study ID #: AR0006
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2010
• Last updated: September 28, 2010
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2010
• Source: Kansas City Veteran Affairs Medical Center
• Contact: Deepthi S Rao, MBBS
• Phone: 816-861-4700
• Email: Deepthi.Rao[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.

Description:

The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.

Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.

Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 462
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.

Exclusion Criteria:

• prior surgical resection of any portion of colon,

• prior history of colon cancer,

• history of inflammatory bowel disease,

• use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure,

• poor general condition or any other reason to avoid prolonged procedure time

• inability to give informed consent,

• inadequate bowel preparation.

• history of polyposis syndrome or HNPCC,

Study Design

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

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer
• Colon Polyps
• Colonic Polyps
• Polyps

Intervention

Device:
• Cap - Transparent retractable extension device.
Attaching a Cap - Transparent retractable extension device.
• Standard
Without attaching a transparent cap to the tip of colonoscope.

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
American Society for Gastrointestinal Endoscopy	Midwest Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the prevalence of adenomas in the two groups.		2 years	No
Secondary	The secondary outcomes are the number of adenomas detected per subject, cecal intubation rate, insertion times, withdrawal times and complication rates in the two arms.		2 years	No