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

Not Applicable

Not yet recruiting

• Conditions: Robotic Gastrectomy; Gastric Cancer
• Interventions: Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy; Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy

• Registration Number: NCT05235932
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11
• Study Start: 2022-02-20
• Primary Completion: 2024-02-20
• Study Completion: 2027-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 570

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic radical total gastrectomy with D2 lymphadenectomy	Laparoscopic radical total gastrectomy with D2 lymphadenectomy	After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
Robotic radical total gastrectomy with D2 lymphadenectomy	Robotic radical total gastrectomy with D2 lymphadenectomy	After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months	3-year disease free survival rate

Secondary Outcome Measures

Name	Time	Method
3-year overall survival rate	36 months	3-year overall survival rate
postoperative nutritional status	3, 6, 9 and 12 months	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
inflammatory immune response	Preoperative 3 days and postoperative 1, 3, and 5 days	The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response
Morbidity rates	30 days	This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
intraoperative morbidity rates	1 day	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
3-year recurrence pattern	36 months	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Total Number of Retrieved Lymph Nodes	1 day	Total Number of Retrieved Lymph Nodes
postoperative recovery course	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
overall postoperative serious morbidity rates	30 days	Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China