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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Diagnostic accuracy 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 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.
Trial sites (1)
Facility
City
Region
Status
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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