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NCT Number: NCT07507071

Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions

The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal.

The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions.

As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions.

The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

In this study, the pathological results of ESD or surgical resection of large specimens were used as the gold standard. The sensitivity of preoperative confocal endomicroscopy examination and pathological biopsy for gastric mucosal cancerous lesions was compared. The study adopted a retrospective approach and invited three experts to conduct offline blind diagnoses of the confocal endoscopy images respectively. First, two experts independently diagnosed all the cases. For those cases with inconsistent diagnosis results, a third expert was then consulted for a final determination. Although it was a retrospective study, the cases included in the research were all prospectively and continuously included in a demonstration project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.

Exclusion criteria

  • lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.

Treatment and study plan

Probe-based Confocal Laser Endomicroscopy

Diagnostic Test

Description: 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.

Other names: Optical biopsy

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

  1. 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 True Positive Rate (TPR), refers to the proportion of patients with early gastric cancer that can be correctly identified by a certain diagnostic technique. High sensitivity means that this detection method can minimize the risk of missed diagnoses to the greatest extent and is applicable for disease screening (such as infectious diseases and early cancer screening).

Secondary outcomes

  1. 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 accurately identify individuals without early gastric cancer (true negative, TN), namely, the proportion of individuals who are actually healthy and test negative.

  2. 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 early gastric cancer and non - cancerous lesions. It is the ratio of the sum of true positives and true negatives to the total test population.

  3. Positive Predictive Value (PPV)

    Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.

    PPV is an important indicator in diagnostic tests, used to assess the probability that a subject actually has early gastric cancer when the test result is positive. Here is a detailed explanation.

  4. Nnegative predictive value (NPV)

    Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.

    The definition of NPV is the probability that a lesion diagnosed as a non-cancerous lesion is actually non-cancerous.

Study contacts

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

Peng Pan, M.D

CONTACT

[email protected]

+8618721828503

Zhaoshen Li, Ph.D

CONTACT

[email protected]

+8618936364880

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 for Gastric Mucosal Lesions

Acronym: pCLE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

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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