Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• 3-year disease-free survival rate [Срок оценки: 3 years]

Вторичные конечные точки (4)

• Overall postoperative complication rate [Срок оценки: 3 years]
• Intraoperative complication rate [Срок оценки: 3 years]
• Overall postoperative complication rate of Clavien-Dindo Grade II or higher [Срок оценки: 3 years]
• 3-year OS rate [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Southwest hospital of AMU — Чунцин
• The Southwest hospital of AMU — Чунцин

Идентификаторы

NCT: NCT06791538 · SYRL-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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