Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

NCT07088744 | Not Yet Recruiting

• 1 other identifier: Optical biopsy-CLE
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Confocal Laser Endomicroscopy; pathological biopsy

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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).

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

Secondary Outcomes (2)

• Accuracy

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

• Specificity

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The absolute indications for curative endoscopic resection (ESD) include moderately and well-differentiated, nonulcerated, mucosal lesions that are ≤2 cm in size. Other relative (expanded) indications for gastric endoscopic submucosal dissection include moderately and well-differentiated superficial cancers that are \>2 cm, lesions ≤3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers ≤2 cm in size.

You may qualify if:

• patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.

You may not qualify if:

• Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (4)

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 200433, China

Location

Northern Theater Command Hospital

Shenyang, Liaoning, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The First Affiliated Hospital of Naval Medical University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosal biopsy specimens and resected specimens

MeSH Terms

Conditions

Stomach Neoplasms; Disease; Gastritis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis

Central Study Contacts

Zhaoshen Li, Ph.D

CONTACT

+8618721828503; li.zhaoshen@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: July 30, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 15, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)