Colon Polyps Clinical Trial
Official title:
Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)
Verified date | January 2009 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years or older. 2. Informed written consent Exclusion Criteria: 1. History of inflammatory bowel disease. 2. Patients with severe cardiopulmonary disease precluding colonoscopy. 3. Presence of conditions not allowing for polypectomy or biopsy (e.g. coagulation disorder). 4. Known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc) 5. Sub-optimal preparation for the procedure, which will be determined by patient history or based on the initial colonoscopy. 6. Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. Review. — View Citation
Kara MA, Peters FP, Rosmolen WD, Krishnadath KK, ten Kate FJ, Fockens P, Bergman JJ. High-resolution endoscopy plus chromoendoscopy or narrow-band imaging in Barrett's esophagus: a prospective randomized crossover study. Endoscopy. 2005 Oct;37(10):929-36. — View Citation
Morson B. President's address. The polyp-cancer sequence in the large bowel. Proc R Soc Med. 1974 Jun;67(6 Pt 1):451-7. — View Citation
Morson BC. Precancerous and early malignant lesions of the large intestine. Br J Surg. 1968 Oct;55(10):725-31. — View Citation
Muto M, Katada C, Sano Y, Yoshida S. Narrow band imaging: a new diagnostic approach to visualize angiogenesis in superficial neoplasia. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S16-20. Review. — View Citation
Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. — View Citation
Stryker SJ, Wolff BG, Culp CE, et al. Natural history of untreated colonic polyps in individual patients. Dis Colon rectum 1989;32:641-52.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI | 2 years | Yes | |
Secondary | 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. | 2 years | Yes |
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