Using a robotic system to improve safety and efficiency in treating early gastric cancer
Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
This study is testing if a new robotic system can make the treatment for early gastric cancer safer and quicker compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06748352 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system to enhance the safety and efficacy of endoscopic submucosal dissection (ESD) for early gastric cancer. Participants will be randomly assigned to receive either traditional ESD or FASTER-assisted ESD. The study aims to determine if the robotic system can reduce muscular injuries and procedure time compared to conventional methods. Patients will also keep a diary of their symptoms post-procedure to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with pathologically verified high-grade intraepithelial neoplasia or intramucosal carcinoma of the stomach.
Not a fit: Patients with deep submucosal invasion, lymph node metastasis, or severe underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient treatment options for patients with early gastric cancer.
How similar studies have performed: While robotic-assisted procedures are gaining traction, this specific application of the FASTER system in ESD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-80. * Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach. Exclusion Criteria: * Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis. * 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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xiuli Zuo Professor, MD, PhD
- Email: zuoxiuli@sdu.edu.cn
- Phone: 86+18560080066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.