NCT06389448 Comparison of pCLE and EB in Gastric Lesion Diagnosis
| NCT ID | NCT06389448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Low Grade Intraepithelial Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 366 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-04 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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 coo