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NCT06881043: STARS-GC09

The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer

Recruiting now Last updated 18 March 2025
What this trial tests

trial in Locally Advanced Gastric Cancer in 300 participants. Currently enrolling.

Timeline
20 November 2024
Primary endpoint
1 December 2026
1 December 2029

Quick facts

Lead sponsorThe First Hospital of Jilin University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment300
Start date20 November 2024
Primary completion1 December 2026
Estimated completion1 December 2029
Sites1 location across China

Conditions studied

Sponsor

The First Hospital of Jilin University

Who can join

Adults 18 to 75, any sex, with Locally Advanced Gastric Cancer or Gastric Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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