Comparing two methods for diagnosing gastric lesions
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 study is testing a new imaging method to see if it can better diagnose gastric lesions compared to the usual biopsy method for people who are scheduled for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06389448 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter study aims to compare probe-based confocal laser endomicroscopy (pCLE) with traditional endoscopic biopsies for diagnosing gastric lesions, particularly in distinguishing low grade from high grade intraepithelial neoplasia. The study seeks to improve diagnostic accuracy and reduce the histological upstaging rate of gastric lesions by utilizing a large sample size and a new classification method for pCLE. Additionally, it will create an endoscopic image database for future research. Participants will be those scheduled for endoscopic submucosal dissection (ESD) surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a pathological diagnosis of low grade or high grade intraepithelial neoplasia or early gastric cancer who are scheduled for ESD.
Not a fit: Patients with advanced gastric cancer, severe comorbidities, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and less invasive diagnostic methods for gastric lesions, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using confocal laser endomicroscopy for gastric lesions, but this study aims to expand on those findings with a larger sample size and a novel classification method.
Eligibility criteria
Show full inclusion / exclusion 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 cooperate with endoscopy or sign informed consent.
Where this trial is running
Wuhan, Hubei
- Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Yilin Gu
- Email: yilingu2019@163.com
- Phone: 86-19884836004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.