A prospective multicenter randomized controlled trial to evaluate the efficacy of Texture and Color Enhancement Imaging (TXI) observation in the detection of colorectal lesions

JRCT ID: jRCT1032230089

Registered date:25/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal lesions
• Date of first enrollment: 29/05/2023
• Target sample size: 960
• Study type: Interventional

Intervention(s)

Randomized allocation of the observation method used for the initial observation
In the standard treatment group (WLI group), on Visit 1 (day 0), Olympus Medical Systems Co., Ltd.'s new colonoscopy system (endoscopic light source/processor device with air and water supply function and video flexible colonoscope) EVIS Observation is performed with WLI of X1. WLI settings use a unified mode for all medical institutions.
The test treatment group (TXI group) used Olympus Medical Systems Co., Ltd.'s new colonoscopy system (light source and processor for endoscopes with air and water supply functions and video flexible colonoscope) EVIS X1 on Visit 1 (day 0). Observation is performed in TXI mode. The TXI mode setting uses a uniform mode for all the medical institutions.

Outcome(s)

• Primary Outcome: Mean adenoma per procedure

Secondary Outcome

1)Adenoma detection rate(ADR)
2)Advanced ADR
3)Polyp detection rate(PDR)
4)Flat polyp detection rate(FDR)
5)Depressed lesion detection rate (DDR)
6)Average number of polyps found per examination
7)Sessile serrated lesion detection rate(SDR)
8)Average number of SSLs found per inspection
9)MAP/ADR by doctor skill level
10)MAP/ADR by gross lesion type
11)Adverse event frequency

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients who meet all of the inclusion criteria 1 to 3 below
1)Patients aged between 40 and 80 at the time of informed consent
2)Patients scheduled for colonoscopy for any of the following:
1.Screening
2.Surveillance after endoscopic treatment (removal of all adenomas)
3.Examination for positive fecal occcult blood test
4.Examination of abdominal symptoms (melena, bloody stool, other symptoms)
3)Patients who have given written informed consent to participate in the study

Exclude criteria

Patients who do not correspond to any of the following1to7
1)Patients with a history of colorectal surgery (excluding appendectomy)
2)Patients with colonic polyposis
3)Patients with inflammatory bowel disease
4)Patients with known colorectal polyps
5)Women who are pregnant or breastfeeding
6)Patients participating in an interventional study on endoscopy other than this study
7)Patients who are judged to be inappropriate for this study by the attending physician or the examining physician, including underlying diseases

Related Information

• Primary Sponsor: Saito Yutaka
• Source(s) of Monetary Support: Olympus Corporation