Comparison of pCLE and EB in Gastric Lesion Diagnosis

Last updated: May 6, 2024
Sponsor: Huazhong University of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

pCLE-gastr

Clinical Study ID

NCT06389448
pCLE vs EB 2024tj
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 18 years old and under 75 years old;
  • Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer afterconventional endoscopy biopsy, whose lesion has clear boundaries under endoscopicobservation and is to be admitted for ESD surgery;
  • Patients who meet the indications for endoscopic resection of early gastric cancer, orLGIN patients who intend to undergo ESD surgery;
  • Patients who are able to provide pathological specimens/sections of previousendoscopic biopsy (in principle, it should be a case of this center).

Exclusion

Exclusion Criteria:

  • Patients with advanced gastric cancer or previous gastrectomy;
  • Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction,acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;
  • Patients who have a positive result in the fluorescein sodium allergy test;
  • Pregnant and lactating women;
  • Patients who have psychiatric disorders and are unable to cooperate with endoscopy orsign informed consent.

Study Design

Total Participants: 366
Treatment Group(s): 1
Primary Treatment: pCLE-gastr
Phase:
Study Start date:
April 11, 2024
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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