Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Naval Military Medical University

Status: Not yet enrolling

Conditions: Gastritis; Gastric Low-grade Intraepithelial Neoplasia; Gastric Cancer (Diagnosis); Gastric High-grade Intraepithelial Neoplasia

Treatments: Diagnostic Test: Pathological biopsy; Diagnostic Test: Probe-based Confocal Laser Endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT07088744

Optical biopsy-CLE

Details and patient eligibility

About

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.

Enrollment: 169 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.

Exclusion criteria

• Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.