TXI for the Recognition of Adenomas in Colonoscopy (TRACK)

University of Roma La Sapienza

Status: Completed

Conditions: Colorectal Polyp

Treatments: Diagnostic Test: TXI Light Imaging; Diagnostic Test: WLI Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04892966

TRACK_GA

Details and patient eligibility

About

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.

Enrollment: 747 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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747 participants in 2 patient groups

TXI (TXI group)

Experimental group

Description:

Arm undergoing normal colonoscopy with TXI light

Treatment:

Diagnostic Test: TXI Light Imaging

WLI (White Light Imaging Group)

Active Comparator group

Description:

Arm undergoing normal colonoscopy with standard white light

Treatment:

Diagnostic Test: WLI Imaging