TXI for the Recognition of Adenomas in Colonoscopy

Study Overview
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Brief Summary
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This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.

Official Title
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Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial

Conditions
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Colorectal Polyp

Intervention / Treatment
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* Diagnostic Test: TXI Light Imaging
* Diagnostic Test: WLI Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - All >40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance Exclusion criteria: patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD). Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment). patients with previous colonic resection. patients on antithrombotic therapy, precluding polyp resection. patients who were not able or refused to give informed written consent.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXI (TXI group)<br>Arm undergoing normal colonoscopy with TXI light | Diagnostic Test: TXI Light Imaging<br>* Standard Colonoscopy using TXI imaging<br>|
| Active Comparator: WLI (White Light Imaging Group)<br>Arm undergoing normal colonoscopy with standard white light | Diagnostic Test: WLI Imaging<br>* Standard Colonoscopy using White Light Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (ADR) | the proportion of participants with at least one adenoma (per-patient analysis) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advanced ADR | as the proportion of participants with at least one advanced adenoma at a per-patient analysis | 1 year | 
| polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject | the total number of detected lesions in each group divided by the total number of participants (per polyp analysis) | 1 year | 
| proximal and flat adenomas detection rate | the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis) | 1 year | 
| Withdrawal time | Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient. | 1 year |