Clinical trial NCT01572428: Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Official title: Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Proximal Colon Cancer
Serrated Colon Lesions
Narrow Band Imaging
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2012-04-06
Enrollment: 898
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

Detailed description: This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age 50-85
* Intact colon and rectum
* American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

* No prior surgical resection of colon or rectum

Primary outcomes:
measure: Total Number of Serrated Lesions Proximal to the Sigmoid Colon
timeFrame: During the colonoscopy procedure
measure: Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
timeFrame: During the colonoscopy procedure
Secondary outcomes:
measure: Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
timeFrame: During the colonoscopy procedure
measure: Total Number of Conventional Adenomas in Entire Colon
timeFrame: During the colonoscopy procedure
measure: Number of Conventional Adenomas Per Patient in Entire Colon
timeFrame: During the colonoscopy procedure
measure: Patients With 1 or More Conventional Adenomas
timeFrame: During the colonoscopy procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Beltway Surgical Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.