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

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

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) .

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Robotic Gastrectomy
• Intervention / Treatment: Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy; Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy

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 Type: Interventional
• Enrollment (Anticipated): 570
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang-ming Huang, MD; Phone Number: +86-13805069676; Email: hcmlr2002@163.com
• Study Contact Backup: Name: Hua-long Zheng, MD; Phone Number: +86-18359190587; Email: 291167038@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic radical total gastrectomy with D2 lymphadenectomy; After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy	Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy; Most surgical procedures are performed using the robot system.
Active Comparator: Laparoscopic radical total gastrectomy with D2 lymphadenectomy; After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy	Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy; Without the robot system, Most surgical procedures are performed using laparoscopic equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate	3-year disease free survival rate	36 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Collaborators: The First Affiliated Hospital of Nanchang University; Chinese PLA General Hospital; Southwest Hospital, China; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Gansu Provincial Hospital; Second Xiangya Hospital of Central South University; The Second Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Guangxi Medical University; Tianjin Medical University Cancer Institute & Hospital; Lanzhou Military Region General Hospital; The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
• Investigators: Study Chair: Chang-Ming Huang, MD, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): February 20, 2024
• Study Completion (Anticipated): February 20, 2027

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Gastric Cancer; robotic radical total gastrectomy; laparoscopic radical total gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2022-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No