Trial Title:
Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
NCT ID:
NCT06515977
Condition:
Adenoma
Sessile Serrated Adenoma
Conditions: Official terms:
Adenoma
Precancerous Conditions
Conditions: Keywords:
texture and color enhancement imaging
colonoscopy
adenoma detection rate
sessile serrated lesion detection rate
adenoma miss rate
sessile serrated lesion miss rate
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
TXI (Group A)
Description:
Patients in Group A will undergo colonoscopy with TXI.
Arm group label:
TXI (Group A)
Intervention type:
Procedure
Intervention name:
TXI followed by WLI (Group B)
Description:
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.
Arm group label:
TXI followed by WLI (Group B)
Intervention type:
Procedure
Intervention name:
WLI (Group C)
Description:
Patients in Group C will undergo colonoscopy with WLI.
Arm group label:
WLI (Group C)
Intervention type:
Procedure
Intervention name:
WLI followed by TXI (Group D)
Description:
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.
Arm group label:
WLI followed by TXI (Group D)
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.
Criteria for 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
Gender:
All
Minimum age:
45 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
The Second Hospital of Hebei Medical University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Huadong Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai 6th People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Eastern Theater Command
Agency class:
Other
Collaborator:
Agency:
Jiangsu Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Collaborator:
Agency:
Wenzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Shanxi Coal Center Hospital
Agency class:
Other
Collaborator:
Agency:
Dalian Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
Seventh Medical Center of PLA Army General Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Zunyi Medical College
Agency class:
Other
Collaborator:
Agency:
Shandong Second People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Third People's Hospital of Chengdu
Agency class:
Other
Collaborator:
Agency:
Lanzhou University Second Hospital
Agency class:
Other
Collaborator:
Agency:
The Third People's Hospital of Jingdezhen
Agency class:
Other
Collaborator:
Agency:
Fudan University Attached Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Qingyuan People's Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06515977
