Clinical trial NCT05235932: the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Robotic Gastrectomy
Keywords: robotic radical total gastrectomy
Gastric Cancer
laparoscopic radical total gastrectomy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: The First Affiliated Hospital of Nanchang University
name: Lanzhou Military Region General Hospital
name: Gansu Provincial Hospital
name: Southwest Hospital, China
name: First Affiliated Hospital of Guangxi Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Second Xiangya Hospital of Central South University
name: Hebei Medical University Fourth Hospital
name: The Affiliated Hospital of Qingdao University
name: The Second Affiliated Hospital of Dalian Medical University
First posted: 2022-02-11
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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) .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Morbidity rates
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: intraoperative morbidity rates
timeFrame: 1 day
measure: overall postoperative serious morbidity rates
timeFrame: 30 days
measure: Total Number of Retrieved Lymph Nodes
timeFrame: 1 day
measure: postoperative recovery course
timeFrame: 30 days
measure: postoperative nutritional status
timeFrame: 3, 6, 9 and 12 months
measure: inflammatory immune response
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-ming Huang, MD
role: STUDY_CHAIR
References: