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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Sessile Serrated Adenoma; Adenoma

Treatments: Procedure: WLI (Group C); Procedure: TXI followed by WLI (Group B); Procedure: TXI (Group A); Procedure: WLI followed by TXI (Group D)

Study type: Interventional

Funder types: Other

Identifiers

NCT06515977

TADR-2024

Details and patient eligibility

About

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.

Enrollment: 2,964 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,964 participants in 4 patient groups

TXI (Group A)

Experimental group

Description:

Arm undergoing colonoscopy with TXI

Treatment:

Procedure: TXI (Group A)

TXI followed by WLI (Group B)

Experimental group

Description:

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

Treatment:

Procedure: TXI followed by WLI (Group B)

WLI (Group C)

Active Comparator group

Description:

Arm undergoing normal colonoscopy with WLI

Treatment:

Procedure: WLI (Group C)

WLI followed by TXI (Group D)

Active Comparator group

Description:

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

Treatment:

Procedure: WLI followed by TXI (Group D)