the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Официальное название

A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Обзор

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .

Подробное описание

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.

Вмешательства

• Процедура Robotic radical total gastrectomy with D2 lymphadenectomy
  Most surgical procedures are performed using the robot system.
• Процедура Laparoscopic radical total gastrectomy with D2 lymphadenectomy
  Without the robot system, Most surgical procedures are performed using laparoscopic equipment.

Первичные конечные точки

• 3-year disease free survival rate [Срок оценки: 36 months]

Вторичные конечные точки (9)

• Morbidity rates [Срок оценки: 30 days]
• 3-year overall survival rate [Срок оценки: 36 months]
• 3-year recurrence pattern [Срок оценки: 36 months]
• intraoperative morbidity rates [Срок оценки: 1 day]
• overall postoperative serious morbidity rates [Срок оценки: 30 days]
• Total Number of Retrieved Lymph Nodes [Срок оценки: 1 day]
• postoperative recovery course [Срок оценки: 30 days]
• postoperative nutritional status [Срок оценки: 3, 6, 9 and 12 months]
• inflammatory immune response [Срок оценки: Preoperative 3 days and postoperative 1, 3, and 5 days]

Критерии участия

Критерии включения

• 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.

3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.

5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent

Критерии исключения

• Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• History of previous gastrectomy(except for ESD/EMR for gastric cancer )
• Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
• History of other malignant disease within the past five years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• FEV1 (forced expiratory volume in one second)<50% of predicted values

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 · 1 центр

• Fujian Medical University Union Hospital — Фучжоу

Идентификаторы

NCT: NCT05235932 · 2022-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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