This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) .

Condition or disease Intervention/treatment Phase
Gastric Cancer Robotic Gastrectomy Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy 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 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 20, 2022
Estimated Primary Completion Date : February 20, 2024
Estimated Study Completion Date : February 20, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Robotic radical total gastrectomy with D2 lymphadenectomy
After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy
 Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy
Most surgical procedures are performed using the robot system.
Active Comparator: Laparoscopic radical total gastrectomy with D2 lymphadenectomy
After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy
 Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy
Without the robot system, Most surgical procedures are performed using laparoscopic equipment.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary 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.

  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05235932


Contacts
Layout table for location contacts
Contact: Chang-ming Huang, MD +86-13805069676 hcmlr2002@163.com
Contact: Hua-long Zheng, MD +86-18359190587 291167038@qq.com

Locations
Layout table for location information
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Fujian Medical University
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
Layout table for investigator information
Study Chair: Chang-ming Huang, MD Fujian Medical University Union Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier: NCT05235932    
Other Study ID Numbers: 2022-02
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

Layout table for additional information
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 Union Hospital:
robotic radical total gastrectomy
Gastric Cancer
laparoscopic radical total gastrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases