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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adenoma; Sessile Serrated Adenoma
• Intervention / Treatment: Procedure: TXI (Group A); Procedure: TXI followed by WLI (Group B); Procedure: WLI (Group C); Procedure: WLI followed by TXI (Group D)

• Study Type: Interventional
• Enrollment (Estimated): 2964
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoshen Li, MD; Phone Number: 86-021-31161365; Email: li.zhaoshen@hotmail.com
• Study Contact Backup: Name: Yu Bai, MD; Phone Number: 86-021-31161335; Email: baiyu1998@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TXI (Group A); Arm undergoing colonoscopy with TXI	Procedure: TXI (Group A); Patients in Group A will undergo colonoscopy with TXI.
Experimental: TXI followed by WLI (Group B); Arm undergoing initial inspection under TXI first, followed by second inspection with WLI	Procedure: TXI followed by WLI (Group B); 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.
Active Comparator: WLI (Group C); Arm undergoing normal colonoscopy with WLI	Procedure: WLI (Group C); Patients in Group C will undergo colonoscopy with WLI.
Active Comparator: WLI followed by TXI (Group D); Arm undergoing initial inspection under WLI first, followed by second inspection with TXI	Procedure: WLI followed by TXI (Group D); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma miss rate	the number of adenomas detected during the second examination divided by the total number of adenomas detected during the first and second colonoscopy	1 years
sessile serrated lesion miss rate	the number of sessile serrated lesions detected during the second examination divided by the total number of sessile serrated lesions detected during the first and second colonoscopy	1 years

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: First People's Hospital of Hangzhou; The First Affiliated Hospital of Nanchang University; The Second Hospital of Hebei Medical University; Henan Provincial People's Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Wenzhou Central Hospital; The First Affiliated Hospital of Dalian Medical University; Shanghai 6th People's Hospital; Jiangsu Provincial People's Hospital; Zunyi Medical College; Huadong Hospital; The General Hospital of Eastern Theater Command; Dalian Municipal Central Hospital; Seventh Medical Center of PLA Army General Hospital; Qingyuan People's Hospital; The Third People's Hospital of Chengdu; Shanxi Coal Center Hospital; The Second Hospital of Lanzhou University; Second Affiliated Hospital of Guangzhou University of Chinese Medicine; Shandong Second People's Hospital; The Third People's Hospital of Jingdezhen; Fudan University Attached Tumor Hospital
• Investigators: Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; adenoma detection rate; adenoma miss rate; texture and color enhancement imaging; sessile serrated lesion detection rate; sessile serrated lesion miss rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Precancerous Conditions
• Other Study ID Numbers: TADR-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No