RecruitingNot ApplicableNCT06791538

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

Sponsor

Southwest Hospital, China

Enrollment

740 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for removing locally advanced stomach cancer: robotic surgery (using a robot-assisted system that gives surgeons greater precision and range of motion) versus standard laparoscopic surgery (a minimally invasive technique using small incisions and a camera). The goal is to determine whether robotic surgery offers better outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with gastric (stomach) adenocarcinoma confirmed by biopsy - Your cancer is locally advanced but has not spread to other organs (clinical stage cT2-4a, any N, M0) - There is no evidence of cancer spreading to the pancreas, spleen, or distant organs before surgery - Your performance status is good (ECOG 0-1, ASA Class I-III) **You may NOT be eligible if...** - Your cancer has spread to other organs (distant metastasis) - Your cancer directly invades the pancreas, spleen, or adjacent organs - You are over 75 or under 18 years old - Your performance status is poor 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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Interventions

PROCEDURERobotic 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.

PROCEDURELaparoscopic 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.