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Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

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ClinicalTrials.gov Identifier: NCT04795063
Recruitment Status : Not yet recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Tracking Information
First Submitted Date  ICMJE March 4, 2021
First Posted Date  ICMJE March 12, 2021
Last Update Posted Date March 12, 2021
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)		 Morbidity rates [ Time Frame: 30 days ]
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • 3-year disease free survival rate [ Time Frame: 36 months ]
    3-year disease free survival rate
  • 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
  • Time of digestive tract reconstruction [ Time Frame: 1 day ]
    From the beginning to the end of digestive tract reconstruction
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 Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Official Title  ICMJE Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Brief Summary To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, 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 total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal 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: Total Robotic Distal Gastrectomy
    All the surgical procedures are performed using the robot system.
  • Procedure: Robotic-Assisted Distal Gastrectomy
    After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
Study Arms  ICMJE
  • Experimental: Total Robotic Distal Gastrectomy
    After exploration and randomization, patients received total robotic distal gastrectomy
    Intervention: Procedure: Total Robotic Distal Gastrectomy
  • Active Comparator: Robotic-Assisted Distal Gastrectomy
    After exploration and randomization, patients received robotic-assisted distal gastrectomy.
    Intervention: Procedure: Robotic-Assisted Distal Gastrectomy
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: March 10, 2021)		 160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age from over 18 to under 75 years
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
  5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  6. American Society of Anesthesiology (ASA) class I to III
  7. Written informed consent

Exclusion Criteria:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
  5. Gastric multiple primary carcinoma
  6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  7. History of other malignant disease within the past 5 years
  8. History of previous neoadjuvant chemotherapy or radiotherapy
  9. History of unstable angina or myocardial infarction within the past 6 months
  10. History of cerebrovascular accident within the past 6 months
  11. History of continuous systematic administration of corticosteroids within 1 month
  12. Requirement of simultaneous surgery for other disease
  13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  14. Forced expiratory volume in 1 second (FEV1)<50% of the 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: Qi-yue Chen, PhD +86-15980235636 690934662@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04795063
Other Study ID Numbers  ICMJE FUGES-022
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
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fujian Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chang-ming Huang, MD Fujian Medical University Union Hospital
PRS Account Fujian Medical University
Verification Date March 2021

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