Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions

Official title

A Multicenter Prospective Randomized Controlled Trial of Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions in Computer-Aided Water Exchange Colonoscopy

Overview

The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.

Detailed description

This will be a multicenter, unblinded investigators, prospective randomized controlled trial (RCT). Randomization (1:1 to WEAID alone and WEAID plus LCI) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WEAID, WEAID-LCI) to see which one is better at detecting CSSL.

Patient recruitment will be conducted at 4 hospitals: University of Montreal Medical Center (CHUM), Quebec, Canada; Evergreen General Hospital, Taoyuan, Taiwan; King Chulalongkorn Memorial Hospital, Bangkok, Thailand; and Ospedale Valduce, Como, Italy. The study period is expected to be 2 years (from August 2025 to July 2027).

Patients aged 40-80 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and indication of colonoscopy (screening, surveillance, diagnostic, or positive FIT or gFOBT result). Mode of sedation will include no sedation, on-demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences.

The study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm). The ELUXEO 7000 system (Fujifilm) will be used. The same endoscopist performs the insertion and withdrawal of colonoscopy. The colonoscope will be inserted with WE method, instead of air insufflation. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water.

Control Method: One arm of the study will include CADe as the control method. The CADe system will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp.

Study method: The other arm entails the addition of a commercially available image-enhanced LCI technique (Fujifilm) to the CADe system. LCI will be activated during the withdrawal phase to enhance visualization of the lesions.

Interventions

• Device Water exchange with AI-assisted detection
  The study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm) The ELUXEO 7000 system (Fujifilm) will be used in this study. During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin wi
• Device Water exchange with AI-assisted detection and LCI
  The study employs high-definition colonoscopy video processors with integrated CADe (CAD-EYE, EW10-EC02, Fujifilm) and LCI systems (Fujifilm).The ELUXEO 7000 system will be used . During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patien

Primary outcome measures

• Clinically significant serrated lesion (CSSL) detection rate [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]

Secondary outcome measures (5)

• Sessile serrated lesion (SSL) detection rate [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]
• Proximal serrated lesion detection rate [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]
• High-risk neoplasm detection rate [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]
• Adenoma detection rate [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]
• Adenoma per colonoscopy [Time frame: One week (after the colonoscopy procedure, when pathology report is released)]

Eligibility criteria

Inclusion criteria

• Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.

Exclusion criteria

• familial adenomatous polyposis and hereditary non-polyposis CRC syndrome
• personal history of serrated polyposis syndrome
• personal history of CRC
• history of inflammatory bowel disease
• previous colonic resection
• overt gastrointestinal bleeding
• emergency colonoscopy or inpatients
• planned EMR or ESD of large polyps
• colon stricture or obstruction
• contraindications to colonoscopy (eg, acute diverticulitis or toxic megacolon)
• antithrombotic therapy precluding complete polyp resection
• American Society of Anesthesiology classification of physical status >3
• pregnant women or women planning pregnancy
• refusal to provide a written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Screening

Study locations

Canada · 1 center

• University of Montreal Medical Center (CHUM) — Montreal

Italy · 1 center

• Ospedale Valduce — Como

Taiwan · 1 center

• Evergreen General Hospital — Taoyuan

Thailand · 1 center

• King Chulalongkorn Memorial Hospital — Bangkok

Publications

• Anderson JC, Hisey W, Mackenzie TA, Robinson CM, Srivastava A, Meester RGS, Butterly LF. Clinically significant serrated polyp detection rates and risk for postcolonoscopy colorectal cancer: data from the New Hampshire Colonoscopy Registry. Gastrointest Endosc. 2022 Aug;96(2):310-317. doi: 10.1016/j.gie.2022.03.001. Epub 2022 Mar 8. PMID 35276209
• Anderson JC, Rex DK, Mackenzie TA, Hisey W, Robinson CM, Butterly LF. Higher Serrated Polyp Detection Rates Are Associated With Lower Risk of Postcolonoscopy Colorectal Cancer: Data From the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2023 Nov 1;118(11):1927-1930. doi: 10.14309/ajg.0000000000002403. Epub 2023 Jul 7. PMID 37417792

Identifiers

NCT: NCT07127471 · WEAID with LCI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗