Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

NCT06791538 | Recruiting

• 1 other identifier: SYRL-01
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Robotic Gastrectomy; Laparoscopic Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival rate

  3 years

Secondary Outcomes (4)

• Overall postoperative complication rate

  3 years

• Intraoperative complication rate

  3 years

• Overall postoperative complication rate of Clavien-Dindo Grade II or higher

  3 years

• 3-year OS rate

  3 years

Study Arms (2)

Robotic Gastrectomy

EXPERIMENTAL

Procedure: Robotic Gastrectomy

Laparoscopic Gastrectomy

ACTIVE COMPARATOR

Procedure: Laparoscopic Gastrectomy

Interventions

Robotic Gastrectomy PROCEDURE

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.

Robotic Gastrectomy

Laparoscopic Gastrectomy PROCEDURE

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.

Laparoscopic Gastrectomy

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years and \< 75 years.
• Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.
• Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.
• No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.
• Preoperative ECOG performance status score of 0 or 1.
• Preoperative ASA (American Society of Anesthesiologists) physical status score of I-III.
• Consent to participate in the study and signing of the informed consent form.

You may not qualify if:

• Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.
• History of upper abdominal surgery (excluding laparoscopic cholecystectomy).
• Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).
• Patient underwent emergency surgery due to gastric tumor bleeding or perforation.
• History of other malignancies, or presence of other malignant tumors detected during preoperative examination.
• Patient has a history of malignant tumor, or other malignant tumors were found during preoperative examination
• ASA (American Society of Anesthesiologists) score \>3.
• Severe psychiatric disorders.
• History of unstable angina or myocardial infarction within the past 6 months.
• History of cerebral infarction or cerebral hemorrhage within the past 6 months.
• Severe pulmonary disease with FEV1 \< 50%.
• Systemic corticosteroid therapy within 1 month prior to the study.
• Need for concurrent surgery for other diseases.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (2)

The Southwest hospital of AMU

Chongqing, Chongqing Municipality, 400038, China

NOT YET RECRUITING

The Southwest hospital of AMU

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yan Shi

CONTACT

13752909448; shiyandoctor@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)