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

What this Trial Is About

Researchers are conducting a prospective multicenter study to compare probe-based confocal laser endomicroscopy (pCLE) with traditional endoscopic biopsies for diagnosing specific gastric lesions, especially distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). The study aims to assess whether pCLE or pCLE combined with biopsy can improve diagnostic accuracy and reduce histological upstaging after endoscopic submucosal dissection (ESD). Additionally, the study will build an endoscopic image database for future research. Participants will undergo a preoperative fluorescein sodium allergy test before pCLE imaging of their gastric tissue. After identifying the lesion location with white light endoscopy, pCLE images are captured in real time at a cellular level. This procedure is followed by routine ESD resection. The study uses a large sample size and a new pCLE classification method to better guide clinical treatment decisions. During the study, researchers will collect and organize participant data, including pCLE images and biopsy results. They will measure the diagnostic accuracy of pCLE and endoscopic biopsy immediately after results are available or within two months of admission. The study also monitors the histological upstaging rate. Participants will be followed through their ESD surgery and associated diagnostic procedures, with data compiled for ongoing and future analysis.

Comparison of pCLE and EB in Gastric Lesion Diagnosis