Clinical trial NCT06515977: Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
Official title: Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adenoma
Sessile Serrated Adenoma
Keywords: texture and color enhancement imaging
colonoscopy
adenoma detection rate
sessile serrated lesion detection rate
adenoma miss rate
sessile serrated lesion miss rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Dalian Medical University
name: The Second Hospital of Hebei Medical University
name: Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: Huadong Hospital
name: Shanghai 6th People's Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: The General Hospital of Eastern Theater Command
name: Jiangsu Provincial People's Hospital
name: First People's Hospital of Hangzhou
name: Wenzhou Central Hospital
name: The First Affiliated Hospital of Nanchang University
name: Shanxi Coal Center Hospital
name: Dalian Municipal Central Hospital
name: Seventh Medical Center of PLA Army General Hospital
name: Henan Provincial People's Hospital
name: Zunyi Medical College
name: Shandong Second People's Hospital
name: The Third People's Hospital of Chengdu
name: Lanzhou University Second Hospital
name: The Third People's Hospital of Jingdezhen
name: Fudan University Attached Tumor Hospital
name: Qingyuan People's Hospital
First posted: 2024-07-23
Enrollment: 2964
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: adenoma detection rate
timeFrame: 1 years
measure: sessile serrated lesion detection rate
timeFrame: 1 years
Secondary outcomes:
measure: adenoma miss rate
timeFrame: 1 years
measure: sessile serrated lesion miss rate
timeFrame: 1 years
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Young 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.