Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06881043

The Safety and Efficacy of Robotic Assisted 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

262 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 and under 75 years
  • Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy
  • Clinical stage cT2-4a, any N stage, M0 according to AJCC 8th Edition
  • Preoperative abdominal enhanced CT and lung CT or PET-CT show no distant metastasis
  • ECOG performance status of 0 or 1
  • ASA class I to III
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Presence of multiple primary gastric cancers or multiple primary cancers
  • History of previous upper abdominal surgery except laparoscopic cholecystectomy
  • History of previous gastric surgery except endoscopic submucosal dissection or mucosal resection
  • Lack of preoperative gastric CT and chest/abdominal imaging or incomplete tumor staging
  • Enlarged regional lymph nodes over 3 cm in diameter on imaging
  • History of other malignant diseases within past 5 years
  • Previous neoadjuvant chemotherapy or radiotherapy
  • Unstable angina or myocardial infarction within past 6 months
  • Cerebrovascular accident within past 6 months
  • Continuous systemic corticosteroid use within 1 month
  • FEV1 less than 50% of predicted values
  • Pregnancy or breastfeeding
  • Severe mental disorder
  • Emergency surgery for complications caused by gastric cancer
  • Preoperative need for combined organ resection
  • Requirement for simultaneous surgery for other diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Hospital of Jilin University

Changchun, Jilin, China, 130012

Actively Recruiting

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Research Team

Q

Quan Wang, Professor

CONTACT

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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