NCT06389448

Comparison of pCLE and EB in Gastric Lesion Diagnosis

Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.

Detailed description

Traditional endoscopic biopsies can only obtain limited tissues from the whole lesion and is invasive, while probe-based confocal laser endomicroscopy (pCLE) can obtain images at a cellular level of the entire lesion area in real time and non-invasively. There were only single-center and small-sample previous researches for comparing the diagnostic accuracy of CLE and traditional biopsy in the entire gastric lesions, and they did not distinguish gastric low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). Thus, this study aims to further verify whether pCLE or pCLE combined with biopsy can improve the diagnostic accuracy of the overall lesion and reduce the histological upstaging rate of gastric LGIN after endoscopic submucosal dissection (ESD) by using large sample data and a new pCLE classification method, so as to achieve better guidance of clinical treatment. While verifying the diagnostic efficacy of pCLE, the data of the participants will be collected and collated, and an endoscopic image database will be constructed for the follow-up research.

Conditions

• Low Grade Intraepithelial Neoplasia
• High Grade Intraepithelial Neoplasia
• Early Gastric Cancer
• Gastric Intraepithelial Neoplasia

Interventions

Type	Name	Description
DEVICE	pCLE-gastr	After identifying the location of the lesion through white light endoscopy, the pCLE operation is performed to acquire images from the specific gastric lesions, and finally the ESD routine is performed.

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-04-29
• Last updated: 2024-05-07

Locations

1 site across 1 country: China