Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2964 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenoma Sessile Serrated Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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TXI (Group A)

Arm undergoing colonoscopy with TXI

Group Type EXPERIMENTAL

TXI (Group A)

Intervention Type PROCEDURE

Patients in Group A will undergo colonoscopy with TXI.

TXI followed by WLI (Group B)

Arm undergoing initial inspection under TXI first, followed by second inspection with WLI

Group Type EXPERIMENTAL

TXI followed by WLI (Group B)

Intervention Type PROCEDURE

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.

WLI (Group C)

Arm undergoing normal colonoscopy with WLI

Group Type ACTIVE_COMPARATOR

WLI (Group C)

Intervention Type PROCEDURE

Patients in Group C will undergo colonoscopy with WLI.

WLI followed by TXI (Group D)

Arm undergoing initial inspection under WLI first, followed by second inspection with TXI

Group Type ACTIVE_COMPARATOR

WLI followed by TXI (Group D)

Intervention Type PROCEDURE

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.

Interventions

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TXI (Group A)

Patients in Group A will undergo colonoscopy with TXI.

Intervention Type 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.

Intervention Type PROCEDURE

WLI (Group C)

Patients in Group C will undergo colonoscopy with WLI.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No