Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.

NCT Number	NCT07088744
Lead Sponsor	Changhai Hospital
Conditions	Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
Enrollment	169 participants
Start Date	2025-07-30
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-09-15 (estimated)
Updated on ClinicalTrials.gov	2025-07-28