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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Total Gastrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 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: Laparoscopic Total Gastrectomy Procedure: Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Active Comparator: Open Total Gastrectomy Procedure: Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.


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


Secondary Outcome Measures :
  1. 3 year-OS [ Time Frame: 3 year ]
    3 year-overall survival

  2. morbidity and mortality rates [ Time Frame: 30 days following surgeries ]
    morbidity and mortality within 30 days following surgeries


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT05537129


Contacts
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Contact: Dazhi Xu, PHD, MD 021-64175590 xudzh@shca.org.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Dazhi Xu, PHD，MD    021-64175590    xudzh@shca.org.cn   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Dazhi Xu, PHD,MD Fudan University
More Information
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Responsible Party: Dazhi Xu, PHD,MD, Fudan University
ClinicalTrials.gov Identifier: NCT05537129    
Other Study ID Numbers: LOTGGC
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Dazhi Xu, Fudan University:
Gastric cancer, Laparoscopic Total Gastrectomy, Open Total 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