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)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Gastric cancer is the fifth most common malignancy and the fourth leading cause of cancer-related deaths. Surgical resection is the primary treatment, with laparoscopic-assisted gastrectomy (LG) being a minimally invasive option. However, LG is limited by restricted instrument mobility and hand tremors, which affect precision. The Da Vinci robotic system enhances surgical precision with 3D magnification, improved hand-eye coordination, tremor filtration, and flexible instruments. It is especially beneficial in complex procedures like D2 lymph node dissection and lower mediastinal lymph node clearance. Unlike laparoscopic surgery, robotic surgery offers superior flexibility and reduced pancreatic injury during dissection. Robotic-assisted gastrectomy (RG) offers advantages over LG, such as reduced blood loss, shorter hospital stays, and improved lymph node dissection. However, its short-term benefits remain debated, and most studies focus on early gastric cancer. The safety and efficacy of RG for advanced gastric cancer are not well-established. Vascular coagulation is crucial in minimally invasive surgery. Ultrasonic devices, though widely used, can cause thermal damage due to high temperatures. In contrast, the Vessel Sealer Extend (VSE) offers greater flexibility and precision. It allows 540° instrument rotation, coagulates vessels up to 7 mm in diameter with lower energy, and minimizes thermal injury. Retrospective studies show RG with VSE may have faster recovery and fewer complications than LG. However, further prospective, multicenter studies are needed to confirm these benefits for advanced gastric cancer. The investigators propose a multicenter, observational study to evaluate RG with VSE in advanced gastric cancer, assessing safety, recovery, and oncological outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Quan Wang, Professor
wquan@jlu.edu.cn
+86 15843073207
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 300
Treatments
Robot-assisted radical gastrectomy using VSE for locally advanced gastric cancer.
The surgeon performed robot-assisted radical gastrectomy using VSE for locally advanced gastric cancer.
laparoscopic-assisted radical gastrectomy for advanced gastric cancer
The surgeon performed laparoscopic-assisted radical gastrectomy for advanced gastric cancer.
Sponsors
Collaborators: The Affiliated Hospital of Xuzhou Medical University, Beijing Tsinghua Changgeng Hospital, The First Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov