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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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ClinicalTrials.gov Identifier: NCT05235932
Recruitment Status : Not yet recruiting
First Posted : February 11, 2022
Last Update Posted : February 11, 2022
Sponsor:
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
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University Union Hospital

Tracking Information
First Submitted Date  ICMJE February 10, 2022
First Posted Date  ICMJE February 11, 2022
Last Update Posted Date February 11, 2022
Estimated Study Start Date  ICMJE February 20, 2022
Estimated Primary Completion Date February 20, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2022)		 3-year disease free survival rate [ Time Frame: 36 months ]
3-year disease free survival rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2022)
  • Morbidity rates [ Time Frame: 30 days ]
    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
  • 3-year overall survival rate [ Time Frame: 36 months ]
    3-year overall survival rate
  • 3-year recurrence pattern [ Time Frame: 36 months ]
    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 [ Time Frame: 1 day ]
    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
  • overall postoperative serious morbidity rates [ Time Frame: 30 days ]
    Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher
  • Total Number of Retrieved Lymph Nodes [ Time Frame: 1 day ]
    Total Number of Retrieved Lymph Nodes
  • postoperative recovery course [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
  • postoperative nutritional status [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Robotic Gastrectomy
Intervention  ICMJE
  • Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy
    Most surgical procedures are performed using the robot system.
  • Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy
    Without the robot system, Most surgical procedures are performed using laparoscopic equipment.
Study Arms  ICMJE
  • Experimental: Robotic radical total gastrectomy with D2 lymphadenectomy
    After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy
    Intervention: Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy
  • Active Comparator: Laparoscopic radical total gastrectomy with D2 lymphadenectomy
    After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
    Intervention: Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2022)		 570
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2027
Estimated Primary Completion Date February 20, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chang-ming Huang, MD +86-13805069676 hcmlr2002@163.com
Contact: Hua-long Zheng, MD +86-18359190587 291167038@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05235932
Other Study ID Numbers  ICMJE 2022-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chang-Ming Huang, Prof., Fujian Medical University Union Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fujian Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Study Chair: Chang-ming Huang, MD Fujian Medical University Union Hospital
PRS Account Fujian Medical University
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP