Comparison of pCLE and EB in Gastric Lesion Diagnosis

Trial Title: Comparison of pCLE and EB in Gastric Lesion Diagnosis

NCT ID: NCT06389448

Condition: Low Grade Intraepithelial Neoplasia
High Grade Intraepithelial Neoplasia
Early Gastric Cancer
Gastric Intraepithelial Neoplasia

Conditions: Official terms:
Stomach Neoplasms
Neoplasms
Carcinoma in Situ

Conditions: Keywords:
confocal laser endomicroscopy
endoscopic biopsy
Intraepithelial Neoplasia
gastric cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Participants undergo pCLE after pre-ESD assessment and before ESD resection.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: pCLE-gastr
Description: 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.
Arm group label: pCLE-gastr

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Status: Recruiting

Contact:
Last name: Bin Cheng, Professor

Phone: 86-027-8366-3333
Email: b.cheng@tjh.tjmu.edu.cn

Contact backup:
Last name: Yilin Gu

Phone: 86-19884836004
Email: yilingu2019@163.com

Start date: April 11, 2024

Completion date: October 2026

Lead sponsor:
Agency: Huazhong University of Science and Technology
Agency class: Other

Source: Huazhong University of Science and Technology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06389448