Robotic surgery for advanced gastric cancer
A Multicenter, Prospective, Observational Cohort Study to Assess the Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer (STARS-GC09)
The First Hospital of Jilin University · NCT06881043
This study is testing if robotic surgery can safely help people with advanced stomach cancer by reducing blood loss and hospital stays compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06881043 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of robotic-assisted surgery using the Vessel Sealer Extend for patients with locally advanced gastric cancer. The Da Vinci robotic system enhances surgical precision through 3D magnification and improved instrument flexibility, addressing limitations of traditional laparoscopic techniques. The study aims to assess outcomes such as blood loss, hospital stay duration, and lymph node dissection effectiveness in patients undergoing robotic gastrectomy. It focuses on patients with specific stages of gastric adenocarcinoma who meet defined eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed primary gastric adenocarcinoma and specific staging criteria.
Not a fit: Patients with multiple primary cancers or a history of significant upper abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown promising results with robotic-assisted surgeries in various cancers, suggesting potential benefits in this approach for gastric cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from over 18 to under 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT2-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition * Preoperative abdominal enhanced CT and lung CT (or PET-CT) showed no distant metastasis * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) class I to III * Written informed consent Exclusion Criteria: * Gastric multiple primary carcinoma or multiple primary cancer * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection ) for gastric cancer) * Preoperative gastric CT evaluation and chest and abdominal imaging evaluation were not performed before surgery, and the clinical stage of the tumor was not comprehensively evaluated * Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging * History of other malignant disease within the past 5 years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within the past 6 months * History of cerebrovascular accident within the past 6 months * History of continuous systematic administration of corticosteroids within 1 month * FEV1\<50% of the predicted values * Women during pregnancy or breast-feeding * Severe mental disorder * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * Preoperative evaluation requires combined organ resection * Requirement of simultaneous surgery for other disease
Where this trial is running
Changchun, Jilin
- First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
Study contacts
- Study coordinator: Quan Wang, Professor
- Email: wquan@jlu.edu.cn
- Phone: +86 15843073207
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.
Conditions: Locally Advanced Gastric Cancer, Gastric Adenocarcinoma, Robot-assisted surgery, Vessel sealer extend, Gastrectomy, Laparoscopic-assisted surgery, Neoplasms, Gastrointestinal Neoplasms