Actively Recruiting
A Multicenter, Prospective, Observational Study to Assess Safety and Efficacy of Robotic Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer
Led by The First Hospital of Jilin University · Updated on 2025-03-18
300
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The First Hospital of Jilin University
Lead Sponsor
J
Jiangsu Cancer Institute & Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of robotic-assisted surgery using the Vessel Sealer Extend (VSE) device in patients with advanced gastric cancer. Gastric cancer is a common and deadly disease typically treated with surgical removal of the tumor. While laparoscopic-assisted gastrectomy (LG) is a minimally invasive option, it has limitations in instrument mobility and precision. The Da Vinci robotic system offers enhanced surgical control, 3D magnification, and tremor reduction, which may improve complex lymph node dissections and reduce pancreatic injury compared to laparoscopic surgery. This study aims to address the unclear benefits of robotic surgery in advanced stages of gastric cancer using the VSE device. The study compares two surgical methods: robotic-assisted radical gastrectomy using the VSE energy device, which features a flexible, wristed instrument allowing precise vessel sealing with less thermal damage, and laparoscopic-assisted radical gastrectomy. The VSE device can rotate 540 degrees and coagulate larger vessels with lower energy, potentially reducing complications. The study is prospective, multicenter, and observational, focusing on assessing safety, recovery, and surgical outcomes of the robotic method with VSE in advanced gastric cancer patients. Participants will undergo various evaluations including imaging scans before surgery and detailed monitoring during and after the surgical procedure. Outcomes include overall postoperative complications within 30 days, inflammatory and immune responses, lymph node retrieval, recovery markers such as prealbumin and albumin levels over 36 months, and long-term survival outcomes up to three years. The study also tracks surgical costs and serious morbidity rates to evaluate the feasibility and benefits of robotic surgery with the VSE device compared to laparoscopic surgery.
CONDITIONS
Brief Title
The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Primary gastric adenocarcinoma confirmed by endoscopic biopsy
- Clinical stage cT2-4a, any N status, M0 as per AJCC 8th Edition
- No distant metastasis on preoperative abdominal and lung CT or PET-CT
- ECOG performance status of 0 or 1
- ASA physical status classification I to III
- Provided written informed consent
You will not qualify if you...
- Multiple primary gastric or other cancers
- Previous upper abdominal surgery except laparoscopic cholecystectomy
- Previous gastric surgery except endoscopic submucosal or mucosal resection
- Lack of preoperative CT and imaging evaluation or incomplete tumor staging
- Enlarged regional lymph nodes over 3 cm diameter on imaging
- Other malignancies within the past 5 years
- Prior neoadjuvant chemotherapy or radiotherapy
- Unstable angina or heart attack within 6 months
- Stroke within 6 months
- Continuous corticosteroid use within 1 month
- Lung function (FEV1) below 50% predicted
- Pregnancy or breastfeeding
- Severe mental disorders
- Emergency surgery due to gastric cancer complications
- Need for combined organ resection
- Simultaneous surgery for other diseases
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 30 days after surgery
Participants undergo robot-assisted or laparoscopic-assisted radical gastrectomy for locally advanced gastric cancer and receive immediate post-operative care.
Approximately 1 hospital stay including surgery and immediate post-operative monitoring
Duration - Up to 3 years postoperatively
Participants are followed up to assess recovery, complications, and survival outcomes after surgery.
Follow-up visits over 3 years for monitoring recovery and survival
Trial Site Locations
Total: 1 location
1
First Hospital of Jilin University
Changchun, Jilin, China, 130012
Actively Recruiting
Research Team
Q
Quan Wang, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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