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Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

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ClinicalTrials.gov Identifier: NCT05537129
Recruitment Status : Recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Dazhi Xu, Fudan University

Tracking Information
First Submitted Date  ICMJE September 8, 2022
First Posted Date  ICMJE September 13, 2022
Last Update Posted Date September 13, 2022
Estimated Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2022)		 3 year-DFS [ Time Frame: 3 year ]
3 year-disease free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2022)
  • 3 year-OS [ Time Frame: 3 year ]
    3 year-overall survival
  • morbidity and mortality rates [ Time Frame: 30 days following surgeries ]
    morbidity and mortality within 30 days following surgeries
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 Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
Official Title  ICMJE A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Brief Summary The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
Detailed Description Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.
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
Intervention  ICMJE Procedure: Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Study Arms  ICMJE
  • Experimental: Laparoscopic Total Gastrectomy
    Intervention: Procedure: Total Gastrectomy
  • Active Comparator: Open Total Gastrectomy
    Intervention: Procedure: Total 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2022)		 600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2027
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
  2. age between 20 and 80 years old
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
  5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
  6. written informed consent
  7. without preoperative chemotherapy and radiotherapy

Exclusion Criteria:

  1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
  2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
  3. perigastric lymphnode≥3cm
  4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
  5. multiple primary tumors
  6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
  7. patients need emergency operation with complication of gastric cancer
  8. adhesion due to the previous intraabdominal surgery
  9. need for combined organ resection due to aggression of gastric cancer of other disease,
  10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
  11. currently participating or participated in other clinical trials in the last 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dazhi Xu, PHD, MD 021-64175590 xudzh@shca.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05537129
Other Study ID Numbers  ICMJE LOTGGC
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: No
Current Responsible Party Dazhi Xu, Fudan University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fudan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dazhi Xu, PHD,MD Fudan University
PRS Account Fudan University
Verification Date September 2022

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