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

Completed · Not applicable

Conditions studied: Adenomatous Polyps

In brief

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.

Key facts

Study ID

NCT01935180

Run by

White River Junction Veterans Affairs Medical Center

People needed

1148

Starts

2010-12-01

Expected to finish

2012-05-01

Last updated by the study team

2018-09-25

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any patient ≥ 50 years old and < 85 years old who presents for a colonoscopy with a potential for polyp resection and who does not meet any of the exclusion criteria mentioned below will be asked to participate

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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• White River Junction VAMC — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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