Comparison of pCLE and EB in Gastric Lesion Diagnosis

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for diagnosing certain stomach conditions, specifically low-grade and high-grade intraepithelial neoplasia (which are changes in the stomach lining that can lead to cancer) and early gastric cancer. The researchers want to see how well probe-based confocal laser endomicroscopy (pCLE) works compared to traditional endoscopic biopsies, which involve taking small samples of tissue from the stomach for testing. The goal is to improve how these conditions are diagnosed and to create a database of images to help with future research.

To participate in this trial, individuals must be between 18 and 75 years old and have already been diagnosed with low-grade or high-grade intraepithelial neoplasia or early gastric cancer through a standard biopsy. Participants should have clearly defined stomach lesions that are planned for endoscopic surgery. However, people with advanced stomach cancer, serious health issues, or certain allergies are not eligible. If you join this study, you can expect to undergo both types of diagnostic procedures and contribute to important research that could improve future treatment options for stomach conditions.

Gender

ALL

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.