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

Primary Purpose

Gastric Cancer, Robotic Gastrectomy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic radical total gastrectomy with D2 lymphadenectomy
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring robotic radical total gastrectomy, Gastric Cancer, laparoscopic radical total gastrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic radical total gastrectomy with D2 lymphadenectomy

Laparoscopic radical total gastrectomy with D2 lymphadenectomy

Arm Description

After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy

After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy

Outcomes

Primary Outcome Measures

3-year disease free survival rate
3-year disease free survival rate

Secondary Outcome Measures

Morbidity rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
3-year overall survival rate
3-year overall survival rate
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.
intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
overall postoperative serious morbidity rates
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
postoperative recovery course
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
postoperative nutritional status
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
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

Full Information

First Posted
February 10, 2022
Last Updated
February 10, 2022
Sponsor
Fujian Medical University
Collaborators
Chinese PLA General Hospital, Tianjin Medical University Cancer Institute & Hospital, The First Affiliated Hospital of Nanchang University, Lanzhou Military Region General Hospital, Gansu Provincial Hospital, Southwest Hospital, China, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Xiangya Hospital of Central South University, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05235932
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2022 (Anticipated)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
Collaborators
Chinese PLA General Hospital, Tianjin Medical University Cancer Institute & Hospital, The First Affiliated Hospital of Nanchang University, Lanzhou Military Region General Hospital, Gansu Provincial Hospital, Southwest Hospital, China, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Xiangya Hospital of Central South University, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, The Affiliated Hospital of Qingdao University, The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Robotic Gastrectomy
Keywords
robotic radical total gastrectomy, Gastric Cancer, laparoscopic radical total gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic radical total gastrectomy with D2 lymphadenectomy
Arm Type
Experimental
Arm Description
After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy
Arm Title
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Arm Type
Active Comparator
Arm Description
After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Robotic radical total gastrectomy with D2 lymphadenectomy
Intervention Description
Most surgical procedures are performed using the robot system.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Intervention Description
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Morbidity rates
Description
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time Frame
36 months
Title
intraoperative morbidity rates
Description
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time Frame
1 day
Title
overall postoperative serious morbidity rates
Description
Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
Time Frame
30 days
Title
Total Number of Retrieved Lymph Nodes
Description
Total Number of Retrieved Lymph Nodes
Time Frame
1 day
Title
postoperative recovery course
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
postoperative nutritional status
Description
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.
Time Frame
3, 6, 9 and 12 months
Title
inflammatory immune response
Description
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
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-ming Huang, MD
Phone
+86-13805069676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua-long Zheng, MD
Phone
+86-18359190587
Email
291167038@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-ming Huang, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China

12. IPD Sharing Statement

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

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