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ClinicalTrials.gov ID

NCT07088744

Lead Sponsor

Changhai HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

169Estimated

Last Update Posted

Jul 28, 2025Actual

Start Date

Jul 30, 2025Estimated

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Sep 15, 2025Estimated

Official Title

Comparison of the Sensitivity of Probe-based Confocal Laser Endomicroscopy and Pathological Biopsy Before Endoscopic Submucosal Dissection

Brief Summary

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.

• Gastric Cancer (Diagnosis)
• Gastric High-grade Intraepithelial Neoplasia
• Gastric Low-grade Intraepithelial Neoplasia
• Gastritis

• Probe-based Confocal Laser Endomicroscopy
• Pathological biopsy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Case-Only

Time Perspective

Retrospective

Lead Sponsor

Changhai HospitalOTHER

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