I-scan for Adenoma Detection

University of California San Francisco (UCSF)

Status: Completed

Conditions: Colorectal Adenomatous Polyps

Treatments: Device: standard high-definition white light; Device: i-scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02811419

P072016

Details and patient eligibility

About

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

Full 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.

Enrollment: 740 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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740 participants in 2 patient groups

i-scan

Active Comparator group

Description:

Inspection with i-scan surface enhancement

Treatment:

Device: i-scan

Standard high-definition white light

Active Comparator group

Description:

Inspection with standard high-definition white light (usual care)

Treatment:

Device: standard high-definition white light