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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05235932
• Other study ID #: 2022-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: February 20, 2027

Study information

• Verified date: February 2022
• Source: Fujian Medical University
• Contact: Chang-ming Huang, MD
• Phone: +86-13805069676
• Email: hcmlr2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 570
• Est. completion date: February 20, 2027
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Robotic Gastrectomy
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (13)

Lead Sponsor

Collaborator

Fujian Medical University

Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Gansu Provincial Hospital, Lanzhou Military Region General Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Nanchang University, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, The Second Affiliated Hospital of Dalian Medical University, The Southwest Hospital of AMU, Tianjin Medical University Cancer Institute & Hospital, Xiangya Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	Morbidity rates	This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.	30 days
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	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
Secondary	intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	overall postoperative serious morbidity rates	Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher	30 days
Secondary	Total Number of Retrieved Lymph Nodes	Total Number of Retrieved Lymph Nodes	1 day
Secondary	postoperative recovery course	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	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
Secondary	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