Clinical trial NCT02811419: I-scan for Adenoma Detection
Official title: I-scan Versus Standard High-Definition White Light for the Detection of Adenomatous Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenomatous Polyps
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 740
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.

Detailed description: This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. 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 sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps 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. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Age 50-75
* Intact colon and rectum
* Willing to sign an informed consent form

Exclusion Criteria:

* Subjects less than 50 years of age or greater than 75 years of age
* Subjects who are in the inpatient unit
* Subjects with diverticulitis,
* Subjects with inflammatory bowel disease
* Subjects with polyposis syndromes
* Subjects with previous surgical resection of any portion of the colon or rectum
* Subjects referred for endoscopic resection of previously diagnosed colorectal polyp

Primary outcomes:
measure: Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Conventional Adenoma Detected
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
Study officials:
affiliation: Primary
name: Jeffrey K Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kidambi TD, Terdiman JP, El-Nachef N, Singh A, Kattah MG, Lee JK. Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20.