Actively Recruiting
Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
Led by Shandong University · Updated on 2024-12-27
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are: 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.
CONDITIONS
Official Title
Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-80.
- Patients diagnosed with high-grade intraepithelial neoplasia or intramucosal carcinoma of the stomach confirmed by pathology.
You will not qualify if you...
- Patients with lesions showing confirmed or possible deep submucosal invasion or lymph node metastasis.
- Patients with severe underlying diseases that prevent endotracheal intubation, general anesthesia, or surgery.
- Patients with a history of stomach cancer treated by radiotherapy or surgery causing structural changes.
- Patients with local recurrence of lesions after previous endoscopic resection.
- Patients unable to provide informed consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
X
Xiuli Zuo Professor, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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