NCT06791538

Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 740 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This \[Study Type: Clinical Trial\] aims to \[Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer\] in \[Participant Population: patients with locally advanced gastric cancer, aged \>18 years and \<75 years\]. The primary questions it seeks to answer are: Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare \[Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy\] to determine whether \[robotic surgery offers advantages in long-term efficacy and perioperative safety\]. Participants will: Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group. Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively). Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.

Conditions

• Gastric Cancer, Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
PROCEDURE	Robotic Gastrectomy	The intervention measures for robotic gastrectomy include: Preoperative Preparation: Comprehensive preoperative examinations, including imaging studies, laboratory tests, and tumor marker assessments, to confirm the diagnosis and staging. Surgical Procedure: Utilizing the da Vinci Surgical System, which provides a high-definition 3D view and flexible robotic arms for enhanced surgical precision. Lymphadenectomy: Systematic D2 lymph node dissection according to oncological standards to ensure thorough removal of regional lymph nodes. Gastrectomy and Reconstruction: Performing subtotal or total gastrectomy based on tumor location and extent, with intracorporeal reconstruction assisted by the robotic system. Postoperative Management: Close monitoring of vital signs, pain management, and early mobilization to facilitate recovery, along with prevention and management of postoperative complications.
PROCEDURE	Laparoscopic Gastrectomy	Preoperative Preparation: Confirm diagnosis and staging through imaging and laboratory tests. Surgical Procedure: Use standard laparoscopic instruments and 2D HD camera. Lymphadenectomy: Perform systematic D2 lymph node dissection. Gastrectomy and Reconstruction: Conduct subtotal or total gastrectomy and intracorporeal reconstruction. Postoperative Management: Monitor vital signs, manage pain, and promote early mobilization.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-01-24
• Last updated: 2025-06-08

Locations

2 sites across 1 country: China