Clinical Trial: Detection and Classification of Colon Polyps
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)
Brief Summary:
Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps.
To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries.
The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.
Detailed Summary:
II. Hypothesis:
- The use of NBI colonoscopy will reduce the miss rate for colon polyps compared to standard white light imaging.
- HDWl and HDNBI are more accurate than standard colonoscopy for the classification of adenomatous polyps in comparison to other non-premalignant polyps.
III. Specific Aims:
- Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI
- Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic, inflammatory, normal) polyps.
- Examine the inter-observer agreement for classification of adenomatous versus non-adenomatous polyps based on standard, NBI and HDWL imaging.
IV. Research Design and Methods:
4.1 Study Design: A prospective phase II cross-over trial. Patients will undergo both procedures (standard, NBI) back to back under conscious sedation. The order of the procedure will be randomized.
4.2 Setting: The study will take place at Mayo Clinic Jacksonville, Division of Gastroenterology, an expert center in the diagnosis and treatment of colon polyps.
4.3 Study Subjects All patients scheduled for colonoscopy at Mayo Clinic Jacksonville will be screened for eligibility using inclusion and exclusion criteria. The patients that are deemed eligible will be offered participation in the study. Informed consent will be obtained and
Sponsor: Mayo Clinic
Current Primary Outcome: 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 2. Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic, inflammatory, normal) polyps. [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: December 26, 2007
Date Started: July 2006
Date Completion:
Last Updated: January 20, 2009
Last Verified: January 2009
