Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial)

NCT01935180 | Completed Results DMC

• 1 other identifier: DMS-22424
• Study Type: interventional
• Target: 1,148
• Locations: 1 country
• Sites: 2

Brief Summary

Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a colonoscopy. It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds, and some early studies have suggested an increased polyp and adenoma detection using this technology. However, the studies have in part substantial methodological limitations (e.g. missing polyp histology, single endoscopist study, polyps not removed at the time of detection). Therefore, at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection. The investigators propose a two-center multiple endoscopists randomized controlled trial. Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean number of adenoma per patient). The investigators will assess and adjust for possible variables that can affect adenoma detection, including withdrawal time and quality of colon preparation. As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists (a minimum of six) new to this method. In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology.

Conditions

Adenomatous Polyps

Keywords

colon polyps; adenoma resection; colon cancer screening; colonoscopy; polyp detection

Outcome Measures

Primary Outcomes (1)

• Mean Number of Adenomas

  Mean number of adenomas per patient in each group.

  duration of colonoscopy

Secondary Outcomes (6)

• Adenoma Detection Rate

  duration of colonoscopy

• Advanced Adenoma Detection Rate

  duration of colonoscopy

• Quality of Bowel Preparation

  duration of colonoscopy

• Withdrawal Time

  time of colonoscope withdrawal

• Ease of Terminal Ileum Intubation

  during colonoscopy

Study Arms (2)

Standard colonoscopy

NO INTERVENTION

Cap assisted colonoscopy

ACTIVE COMPARATOR

A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.

Device: Colonoscopy Cap

Interventions

Colonoscopy Cap DEVICE

4mm transparent cap (Olympus) mounted to the tip of a colonoscope.

Cap assisted colonoscopy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with known inflammatory bowel disease or active colitis
• Patients with familial adenomatous polyposis or other genetic syndromes that are associated with a high number of colonic polyps
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class \> 3)
• Patients on coumadin at the time of the procedure or with a coagulopathy and an elevated INR ≥ 1.5, or platelets \< 50
• Patients who do not consent

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

Related Publications (3)

• von Renteln D, Kaltenbach T, Rastogi A, Anderson JC, Rosch T, Soetikno R, Pohl H. Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2018 May;16(5):706-714. doi: 10.1016/j.cgh.2017.11.036. Epub 2017 Nov 23.

  PMID: 29174789 DERIVED

• von Renteln D, Robertson DJ, Bensen S, Pohl H. Prolonged cecal insertion time is associated with decreased adenoma detection. Gastrointest Endosc. 2017 Mar;85(3):574-580. doi: 10.1016/j.gie.2016.08.021. Epub 2016 Aug 31.

  PMID: 27590962 DERIVED

• Pohl H, Bensen SP, Toor A, Gordon SR, Levy LC, Berk B, Anderson PB, Anderson JC, Rothstein RI, MacKenzie TA, Robertson DJ. Cap-assisted colonoscopy and detection of Adenomatous Polyps (CAP) study: a randomized trial. Endoscopy. 2015 Oct;47(10):891-7. doi: 10.1055/s-0034-1392261. Epub 2015 Jun 30.

  PMID: 26126162 DERIVED

MeSH Terms

Conditions

Adenomatous Polyps; Colonic Polyps

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Heiko Pohl
• Organization: VA Medical Center

heiko.pohl@dartmouth.edu

8022959362

Study Officials

• Heiko Pohl

  White River Junction VAMC, Dartmouth Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: September 4, 2013
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 25, 2018
• Results First Posted: May 30, 2017

Record last verified: 2018-08

Locations

US (2)