RecruitingNCT06881043

The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally 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)


Sponsor

The First Hospital of Jilin University

Enrollment

300 participants

Start Date

Nov 20, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of robotic-assisted surgery using a specific energy device (Vessel Sealer Extend) for people with locally advanced gastric (stomach) cancer. Robotic surgery may offer greater precision than open surgery, and this trial looks at outcomes including cancer control and recovery. **You may be eligible if:** - You are between 18 and 75 years old - You have been confirmed by biopsy to have gastric adenocarcinoma (a specific type of stomach cancer) - Your cancer is locally advanced (stages cT2–T4a, with or without lymph node involvement) but has not spread to distant organs - Your scans show no distant metastases - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if:** - Your stomach cancer has spread to other organs (metastatic) - You have had prior stomach surgery or chemotherapy for this cancer - You have serious heart, lung, kidney, or liver problems - You are under 18 or over 75 years old - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

First Hospital of Jilin University

Changchun, Jilin, China

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NCT06881043


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