Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorChanghai Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
TXI (Group A)
Procedure/SurgeryPatients in Group A will undergo colonoscopy with TXI.
TXI followed by WLI (Group B)
Procedure/SurgeryPatients 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.
WLI (Group C)
Procedure/SurgeryPatients in Group C will undergo colonoscopy with WLI.
WLI followed by TXI (Group D)
Procedure/SurgeryPatients 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.
Treatment groups
2,964 Participants
are divided into 4 treatment groupsGroup A: TXI (Group A)Experimental treatment 1 intervention
Group B: TXI followed by WLI (Group B)Experimental treatment 1 intervention
Group C: WLI (Group C)Active comparator 1 intervention
Group D: WLI followed by TXI (Group D)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
adenoma detection rate
the number of patients with one or more adenomas detected and removed divided by the total number of patient
Time frame
1 years2
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
Time frame
1 yearsSecondary outcomes
1
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
Time frame
1 years2
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
Time frame
1 yearsLocations
Sponsors and contacts
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Changhai Hospital
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Collaborator
Huadong Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
The General Hospital of Eastern Theater Command
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
First People's Hospital of Hangzhou
Collaborator
Wenzhou Central Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Shanxi Coal Center Hospital
Collaborator
Dalian Municipal Central Hospital
Collaborator
Seventh Medical Center of PLA Army General Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Zunyi Medical College
Collaborator
Shandong Second People's Hospital
Collaborator
The Third People's Hospital of Chengdu
Collaborator
Lanzhou University Second Hospital
Collaborator
The Third People's Hospital of Jingdezhen
Collaborator
Fudan University Attached Tumor Hospital
Collaborator
Qingyuan People's Hospital
Collaborator
Source ClinicalTrials.gov
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