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

NCT06881043 | Recruiting DMC

• 1 other identifier: STARS-GC09
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Gastric Cancer; Gastric Adenocarcinoma

Keywords

Robot-assisted surgery; Vessel sealer extend; Gastrectomy; Laparoscopic-assisted surgery; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• Overall postoperative morbidity rates

  Overall complication rates within 30 days after surgery in patients.

  Within 30 days after surgery

Secondary Outcomes (13)

• comprehensive complication index, CCI

  Within 30 days after surgery

• Intraoperative morbidity rates

  Within 30 days after surgery

• Overall postoperative serious morbidity rates

  Within 30 days after surgery

• Number of retrieved lymph nodes

  Within 30 days after surgery

• Postoperative recovery

  Within 30 days after surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Primary gastric adenocarcinoma at the stage of cT2-4a, N-/+, M0.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Jiangsu Cancer Institute & Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130012, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Digestive System Diseases

Central Study Contacts

Quan Wang, Professor

CONTACT

+86 15843073207; wquan@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 18, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)