Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
366 participants
INTERVENTIONAL
2024-04-11
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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pCLE-gastr
pCLE will be used to acquire the images from the gastric tissue of the participants after preoperative fluorescein sodium allergy test (negative) and pre-ESD assessment，and before ESD resection.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Bin Cheng
professor
Locations
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Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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pCLE vs EB 2024tj
Identifier Type: -
Identifier Source: org_study_id
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