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Recruiting NCT06389448

Comparison of pCLE and EB in Gastric Lesion Diagnosis

No phase Interventional Low Grade Intraepithelial Neoplasia High Grade Intraepithelial Neoplasia Early Gastric Cancer Gastric Intraepithelial Neoplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pCLE-gastr.
Who it may be relevant to
Registry conditions: Low Grade Intraepithelial Neoplasia, High Grade Intraepithelial Neoplasia, Early Gastric Cancer, Gastric Intraepithelial Neoplasia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion [Time frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months]
Secondary outcome measures (1)
  • The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion [Time frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months]

Eligibility criteria

Inclusion criteria

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

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 or sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06389448 · pCLE vs EB 2024tj

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗