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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Robotic Gastrectomy Procedure: Total Robotic Distal Gastrectomy Procedure: Robotic-Assisted Distal Gastrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Total Robotic Distal Gastrectomy
After exploration and randomization, patients received total robotic distal gastrectomy
 Procedure: Total Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
Active Comparator: Robotic-Assisted Distal Gastrectomy
After exploration and randomization, patients received robotic-assisted distal gastrectomy.
 Procedure: Robotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.


Outcome Measures
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Primary Outcome Measures :
  1. Morbidity rates [ Time Frame: 30 days ]
    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.


Secondary Outcome Measures :
  1. 3-year disease free survival rate [ Time Frame: 36 months ]
    3-year disease free survival rate

  2. 3-year overall survival rate [ Time Frame: 36 months ]
    3-year overall survival rate

  3. 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.

  4. intraoperative morbidity rates [ Time Frame: 1 day ]
    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

  5. 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

  6. Total Number of Retrieved Lymph Nodes [ Time Frame: 1 day ]
    Total Number of Retrieved Lymph Nodes

  7. postoperative recovery course [ Time Frame: 30 days ]
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

  8. 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.

  9. 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

  10. Time of digestive tract reconstruction [ Time Frame: 1 day ]
    From the beginning to the end of digestive tract reconstruction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795063


Contacts
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Contact: Chang-ming Huang, MD +86-13805069676 hcmlr2002@163.com
Contact: Qi-yue Chen, PhD +86-15980235636 690934662@qq.com

Locations
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China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Contact: Changming Huang, M.D., Ph.D.    +86-133-6591-0253    hcmlr2002@163.com   
Principal Investigator: Changming Huang, M.D., Ph.D.         
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Chang-ming Huang, MD Fujian Medical University Union Hospital
More Information
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Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT04795063    
Other Study ID Numbers: FUGES-022
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University:
Gastric Cancer
robotic assisted distal gastrectomy
total robotic distal gastrectomy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases