Comparison of pCLE and EB in Gastric Lesion Diagnosis

May 6, 2024 updated by: Bin Cheng, Huazhong University of Science and Technology

Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Traditional endoscopic biopsies can only obtain limited tissues from the whole lesion and is invasive, while probe-based confocal laser endomicroscopy (pCLE) can obtain images at a cellular level of the entire lesion area in real time and non-invasively. There were only single-center and small-sample previous researches for comparing the diagnostic accuracy of CLE and traditional biopsy in the entire gastric lesions, and they did not distinguish gastric low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). Thus, this study aims to further verify whether pCLE or pCLE combined with biopsy can improve the diagnostic accuracy of the overall lesion and reduce the histological upstaging rate of gastric LGIN after endoscopic submucosal dissection (ESD) by using large sample data and a new pCLE classification method, so as to achieve better guidance of clinical treatment. While verifying the diagnostic efficacy of pCLE, the data of the participants will be collected and collated, and an endoscopic image database will be constructed for the follow-up research.

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pCLE-gastr
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Time Frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Time Frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
Using the pathological diagnostic result as the ending, the histological upstaging rate from endoscopic biopsy or pCLE will be used to evaluate the diagnostic efficacy.
immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pCLE vs EB 2024tj

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on pCLE-gastr

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe