Comparison of pCLE and EB in Gastric Lesion Diagnosis

NCT06389448 | Recruiting

• 1 other identifier: pCLE vs EB 2024tj
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.

Conditions

Low Grade Intraepithelial Neoplasia; High Grade Intraepithelial Neoplasia; Early Gastric Cancer; Gastric Intraepithelial Neoplasia

Keywords

confocal laser endomicroscopy; endoscopic biopsy; Intraepithelial Neoplasia; gastric cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion

  Using the pathological diagnostic result as the criteria, the accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be used to evaluate the diagnostic efficacy in diagnosing LGIN, HGIN and early gastric cancer.

  immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months

Secondary Outcomes (1)

• The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion

  immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months

Study Arms (1)

pCLE-gastr

OTHER

pCLE will be used to acquire the images from the gastric tissue of the participants after preoperative fluorescein sodium allergy test (negative) and pre-ESD assessment，and before ESD resection.

Device: pCLE-gastr

Interventions

pCLE-gastr DEVICE

After identifying the location of the lesion through white light endoscopy, the pCLE operation is performed to acquire images from the specific gastric lesions, and finally the ESD routine is performed.

pCLE-gastr

Eligibility Criteria

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

You may qualify if:

• Over 18 years old and under 75 years old;
• Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;
• Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;
• Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).

You may not qualify if:

• Patients with advanced gastric cancer or previous gastrectomy;
• Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;
• Patients who have a positive result in the fluorescein sodium allergy test;
• Pregnant and lactating women;
• Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Yilin Gu

CONTACT

86-19884836004; yilingu2019@163.com

Bin Cheng, Pro.

CONTACT

86-13986097542; b.cheng@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Participants undergo pCLE after pre-ESD assessment and before ESD resection.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: April 11, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)