TXI for the Recognition of Adenomas in Colonoscopy

University of Roma La Sapienza747 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

747

Conditions

Colorectal Polyp

Interventions

TXI Light ImagingDIAGNOSTIC_TEST

Standard Colonoscopy using TXI imaging

WLI ImagingDIAGNOSTIC_TEST

Standard Colonoscopy using White Light Imaging

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale Dei Castelli

Ariccia, Rome, Italy

Outcomes

Primary Outcomes

Adenoma Detection Rate (ADR)

the proportion of participants with at least one adenoma (per-patient analysis)

Time frame: 1 year

Secondary Outcomes

Advanced ADR

as the proportion of participants with at least one advanced adenoma at a per-patient analysis

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 1 year

Data from ClinicalTrials.gov

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