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

NCT07507071 | Not Yet Recruiting

• 1 other identifier: pCLE vs. Pathological Biopsy
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Gastric Cancer

Keywords

Pathological biopsy; Early gastric cancer; High-grade intraepithelial neoplasia; Probe-based confocal Laser endomicroscopy; Endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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).

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

Secondary Outcomes (4)

• Specificity

  The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.

• Accuracy

  The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.

• Positive Predictive Value (PPV)

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

• Nnegative predictive value (NPV)

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

Interventions

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.

Also known as: 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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population primarily consisted of patients who had undergone both preoperative pathological biopsy and pCLE examination and then received endoscopic submucosal dissection (ESD) treatment. As both pathological biopsy and pCLE struggle to achieve a perfect diagnosis, this study employed the pathological diagnosis obtained via ESD surgery as the gold standard to compare the sensitivity, specificity, and accuracy of pathological biopsy and pCLE in diagnosing early gastric cancer.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Naval Medical University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosal biopsy specimens and resected specimens were all stored in the hospital pathology department in accordance with standard medical procedures.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhaoshen Li, Ph.D

CONTACT

+8618936364880; li.zhaoshen@hotmail.com

Peng Pan, M.D

CONTACT

+8618721828503; li.zhaoshen@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastroenterology

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: April 2, 2026
• Study Start: March 30, 2026
• Primary Completion: April 10, 2026
• Study Completion: April 15, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)