Comparison of pCLE and EB in Gastric Lesion Diagnosis
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
Huazhong University of Science and Technology
366 participants
Apr 11, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
Interventions
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.
Locations(1)
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NCT06389448