Actively Recruiting
Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
Led by Shandong University · Updated on 2024-12-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system to see if it can improve the safety and effectiveness of endoscopic submucosal dissection (ESD) for early gastric cancer. The study aims to find out whether using the FASTER system reduces muscular injuries and shortens procedure and dissection times compared to the traditional ESD method. This pilot randomized controlled study is led by Shandong University. Participants will be randomly assigned to one of two groups: one group will receive ESD with the help of the FASTER system, while the other will undergo the conventional ESD procedure. Both procedures focus on treating early-stage stomach cancers by carefully removing affected tissue. The FASTER system is designed to provide better tissue traction for safer and more efficient dissection. During the study, participants will keep a diary to record symptoms after their procedure. Researchers will monitor safety by measuring the number of muscular injuries within 24 hours after ESD. They will also assess several other outcomes such as bleeding during the procedure, the time required for hemostasis, procedure duration, and success rates of tissue removal. The study involves careful follow-up within the first day after treatment to evaluate these factors.
CONDITIONS
Brief 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 to 80 years
- Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) of the stomach
- Patients with pathologically verified intramucosal carcinoma of the stomach
You will not qualify if you...
- Lesions with confirmed or potential deep submucosal invasion or lymph node metastasis
- Severe underlying diseases that prevent endotracheal intubation, general anesthesia, or surgery
- History of gastric malignancy with previous radiotherapy or surgery causing changes in stomach structure
- Lesions with local recurrence after endoscopic resection
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure and recovery within 24 hours
Participants undergo endoscopic submucosal dissection (ESD) for early gastric cancer either with the assistance of the FASTER robot system or following the conventional procedure.
1 procedure visit and observation within 24 hours
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
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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