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

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.

Conditions

• Adenoma
• Sessile Serrated Adenoma

Interventions

PROCEDURE

TXI (Group A)

Patients in Group A will undergo colonoscopy with TXI.

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.

PROCEDURE

WLI (Group C)

Patients in Group C will undergo colonoscopy with WLI.

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou University of Chinese Medicine

  collaborator UNKNOWN

• Huadong Hospital

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• The General Hospital of Eastern Theater Command

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Wenzhou Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Shanxi Coal Center Hospital

  collaborator UNKNOWN

• Dalian Municipal Central Hospital

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• Shandong Second People's Hospital

  collaborator UNKNOWN

• The Third People's Hospital of Chengdu

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• The Third People's Hospital of Jingdezhen

  collaborator UNKNOWN

• Fudan University Attached Tumor Hospital

  collaborator UNKNOWN

• Qingyuan People's Hospital

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhaoshen Li, MD · Changhai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2025-08-01

Completion

2025-08-01