Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial
1 other identifier
interventional
2,964
0 countries
N/A
Brief Summary
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJuly 23, 2024
June 1, 2024
1 year
July 17, 2024
July 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
adenoma detection rate
the number of patients with one or more adenomas detected and removed divided by the total number of patient
1 years
sessile serrated lesion detection rate
the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients
1 years
Secondary Outcomes (2)
adenoma miss rate
1 years
sessile serrated lesion miss rate
1 years
Study Arms (4)
TXI (Group A)
EXPERIMENTALArm undergoing colonoscopy with TXI
TXI followed by WLI (Group B)
EXPERIMENTALArm undergoing initial inspection under TXI first, followed by second inspection with WLI
WLI (Group C)
ACTIVE COMPARATORArm undergoing normal colonoscopy with WLI
WLI followed by TXI (Group D)
ACTIVE COMPARATORArm undergoing initial inspection under WLI first, followed by second inspection with TXI
Interventions
Patients in group B will first undergo colonoscopy with TXI and every polyp found should be removed. Then switch to WLI for a second withdrawal to detect lesions that were not observed the first time.
Patients in group D will first undergo colonoscopy with WLI and every polyp found should be removed. Then switch to TXI for a second withdrawal to detect lesions that were not observed the first time.
Eligibility Criteria
You may qualify if:
- patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent
You may not qualify if:
- Surveillance, diagnostic or therapeutic colonoscopy
- Patients with an already known or suspected colorectal tumour
- Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination
- Pregnant or lactating women
- Patients with gastrointestinal tract obstruction
- Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with failed cecal intubation
- Patients with poor bowel preparation quality that necessitated a second bowel preparation
- Patients with a history of colonic resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicinecollaborator
- Huadong Hospitalcollaborator
- Shanghai 6th People's Hospitalcollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- The General Hospital of Eastern Theater Commandcollaborator
- Jiangsu Provincial People's Hospitalcollaborator
- First People's Hospital of Hangzhoucollaborator
- Wenzhou Central Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Shanxi Coal Center Hospitalcollaborator
- Dalian Municipal Central Hospitalcollaborator
- Seventh Medical Center of PLA Army General Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Zunyi Medical Collegecollaborator
- Shandong Second People's Hospitalcollaborator
- The Third People's Hospital of Chengducollaborator
- Lanzhou University Second Hospitalcollaborator
- The Third People's Hospital of Jingdezhencollaborator
- Fudan University Attached Tumor Hospitalcollaborator
- Qingyuan People's Hospitalcollaborator
Related Publications (3)
Wei J, Zhao S, Bai Y. Impact of Texture and Color Enhancement Imaging on Adenoma and Sessile Serrated Lesion Detection: Much More to Explore. Gastroenterology. 2024 Jul;167(2):413-414. doi: 10.1053/j.gastro.2024.01.014. Epub 2024 Jan 13. No abstract available.
PMID: 38224857BACKGROUNDAntonelli 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: 37451283BACKGROUNDYoung E, Rajagopalan A, Tee D, Sathananthan D, Hoile S, Singh R. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14.
PMID: 37839498BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, MD
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 23, 2024
Study Start
August 1, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
July 23, 2024
Record last verified: 2024-06