RecruitingNot ApplicableNCT06389448

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


Sponsor

Huazhong University of Science and Technology

Enrollment

366 participants

Start Date

Apr 11, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two advanced endoscopic techniques — probe-based confocal laser endomicroscopy (pCLE, a microscopic real-time imaging tool) and endoscopic biopsy with a special dye (EB) — to see which more accurately determines the extent of early stomach cancer or precancerous lesions before minimally invasive removal surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with early stomach cancer or high- or low-grade stomach dysplasia (a precancerous condition) - You are scheduled for endoscopic submucosal dissection (ESD) surgery - Previous biopsy samples from your lesion are available for comparison **You may NOT be eligible if...** - You have advanced (not early-stage) stomach cancer or have had previous stomach removal surgery - You have severe heart or lung problems, liver cirrhosis, kidney dysfunction, or clotting disorders - You have an allergy to fluorescein dye - You are pregnant or breastfeeding - You have a psychiatric condition that prevents cooperation with endoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEpCLE-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.


Locations(1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06389448


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