TXI for the Recognition of Adenomas in Colonoscopy
TRACK
Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
1 other identifier
interventional
747
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedNovember 3, 2022
November 1, 2022
1.1 years
May 3, 2021
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma Detection Rate (ADR)
the proportion of participants with at least one adenoma (per-patient analysis)
1 year
Secondary Outcomes (4)
Advanced ADR
1 year
polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject
1 year
proximal and flat adenomas detection rate
1 year
Withdrawal time
1 year
Study Arms (2)
TXI (TXI group)
EXPERIMENTALArm undergoing normal colonoscopy with TXI light
WLI (White Light Imaging Group)
ACTIVE COMPARATORArm undergoing normal colonoscopy with standard white light
Interventions
Standard Colonoscopy using White Light Imaging
Eligibility Criteria
You may qualify if:
- \- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Dei Castelli
Ariccia, Rome, 00040, Italy
Related Publications (1)
Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14.
PMID: 37451283DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Consultant Gastroenterologist, PhD Student
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 19, 2021
Study Start
April 1, 2021
Primary Completion
April 30, 2022
Study Completion
September 30, 2022
Last Updated
November 3, 2022
Record last verified: 2022-11