Comparison of pCLE and EB in Gastric Lesion Diagnosis

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389448
• Other study ID #: pCLE vs EB 2024tj
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2024
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: Huazhong University of Science and Technology
• Contact: Yilin Gu
• Phone: 86-19884836004
• Email: yilingu2019[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: October 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Early Gastric Cancer
• Gastric Intraepithelial Neoplasia
• High Grade Intraepithelial Neoplasia
• Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion	Using the pathological diagnostic result as the criteria, the accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be used to evaluate the diagnostic efficacy in diagnosing LGIN, HGIN and early gastric cancer.	immediatly after the diagnostic result of biopsy, ESD and pCLE is available,or admission up to 2 months
Secondary	The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion	Using the pathological diagnostic result as the ending, the histological upstaging rate from endoscopic biopsy or pCLE will be used to evaluate the diagnostic efficacy.	immediatly after the diagnostic result of biopsy, ESD and pCLE is available,or admission up to 2 months