Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Not yet recruiting

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

• Registration Number: NCT07088744
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-07-30
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.	Sensitivity, also known as the true positive rate (TPR), refers to the proportion of individuals in the actual patient group that a diagnostic test can correctly identify as positive (i.e., accurately detect cases). High sensitivity means that this detection method can minimize the risk of missed diagnosis to the greatest extent and is suitable for screening diseases (such as infectious diseases and early cancer screening).

Secondary Outcome Measures

Name	Time	Method
Accuracy	The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.	Accuracy refers to a comprehensive indicator that measures the ability of a medical test or diagnostic method to correctly distinguish between the target disease (such as being ill or not ill). It is the ratio of the sum of true positives and true negatives to the total test population.
Specificity	The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.	Specificity refers to the ability of a diagnostic test to correctly identify individuals who do not have the disease (true negative, TN), that is, the proportion of people who are actually not ill and have a negative test result.

Trial Locations

Locations (4)

Guangxi Zhuang Autonomous Region People's Hospital; 🇨🇳 Nanning, Guangxi, China

Northern Theater Command Hospital; 🇨🇳 Shenyang, Liaoning, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of Naval Medical University; 🇨🇳 Shanghai, China