Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
NCT ID: NCT06748352
Last Updated: 2024-12-27
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
50 participants
INTERVENTIONAL
2024-12-30
2025-03-01
Brief Summary
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Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.
Participants will:
Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.
Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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FASTER-assisted ESD group
Patients in this group undergo ESD with the assistance of the FASTER system.
FASTER-assisted ESD
The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.
Conventional ESD group
Patients in this group undergo ESD following the clinically established pattern.
Conventional ESD
The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.
Interventions
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FASTER-assisted ESD
The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.
Conventional ESD
The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.
Eligibility Criteria
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Inclusion Criteria
* Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.
Exclusion Criteria
* Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
* Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
* Patients have lesions with local recurrence after endoscopic resection.
* Patients unable to obtain informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Shandong University
OTHER
Responsible Party
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Xiuli Zuo
Professor, MD, PhD
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Xiuli Zuo Professor, MD, PhD
Role: primary
Other Identifiers
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SDU-QILU-G015
Identifier Type: -
Identifier Source: org_study_id