I-scan for Adenoma Detection

Not Applicable

Completed

• Conditions: Colorectal Adenomatous Polyps
• Interventions: Device: i-scan; Device: standard high-definition white light

• Registration Number: NCT02811419
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-23
• Study Start: 2017-02-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-31
• Results First Submitted: 2019-03-25
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Results First Posted: 2019-04-17
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-scan	i-scan	Inspection with i-scan surface enhancement
Standard high-definition white light	standard high-definition white light	Inspection with standard high-definition white light (usual care)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected	12 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Conventional Adenoma Detected	12 months

Trial Locations

Locations (1)

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States