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.

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Key information

Conditions

Gastric Cancer (Diagnosis) Digestive System Diseases Digestive System Neoplasms Disease Gastric High-grade Intraepithelial Neoplasia Gastric Low-grade Intraepithelial Neoplasia Gastritis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangxi Zhuang Autonomous Region People's Hospital, Nanning, Guangxi, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probe-based Confocal Laser Endomicroscopy

Diagnostic Test

Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. All patients scheduled for endoscopic submucosal dissection (ESD) of gastric lesions must undergo probe-based confocal laser endomicroscopy (pCLE) prior to the ESD procedure.

Pathological biopsy

Diagnostic Test

A pathological biopsy is a medical procedure that involves the removal of a small sample of tissue or cells from the body for microscopic examination. It is a crucial diagnostic tool used to identify diseases, particularly cancer, infections, inflammatory conditions, and other abnormalities.

Primary outcomes

Sensitivity

Time frame: 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 outcomes

Accuracy

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaoshen Li, Ph.D

CONTACT

[email protected]

+8618721828503

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 28, 2025
Registry last updated: Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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