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Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

Primary Purpose

Stomach Neoplasms

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Totally Laparoscopic Total Gastrectomy
Laparoscopy Assisted Total Gastrectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted Total Gastrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 to 75 years old
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
  4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  6. ASA (American Society of Anesthesiology) class I to III
  7. Written informed consent

Exclusion Criteria:

  1. Pregnant and lactating women
  2. Suffering from severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
  6. History of other malignant disease within the past 5 years
  7. History of previous neoadjuvant chemotherapy or radiotherapy
  8. History of unstable angina or myocardial infarction within the past 6 months
  9. History of cerebrovascular accident within the past 6 months
  10. History of continuous systematic administration of corticosteroids within 1 month
  11. Requirement of simultaneous surgery for other disease
  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  13. FEV1<50% of the predicted values

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Totally Laparoscopic Total Gastrectomy

    Laparoscopy Assisted Total Gastrectomy

    Arm Description

    Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.

    Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

    Outcomes

    Primary Outcome Measures

    overall postoperative morbidity rates
    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

    Secondary Outcome Measures

    3-year overall survival rate
    3-year disease free survival rate
    3-year recurrence pattern
    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
    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
    Time to first ambulation
    Time to first ambulation in hours is used to assess the postoperative recovery course.
    Time to first flatus
    Time to first flatus in days is used to assess the postoperative recovery course.
    Time to first liquid diet
    Time to first liquid diet in days is used to assess the postoperative recovery course.
    Time to first soft diet
    Time to first soft diet in days is used to assess the postoperative recovery course.
    Duration of postoperative hospital stay
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
    Postoperative pain
    Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
    The variation of weight
    The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
    The variation of cholesterol
    The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
    The results of endoscopy
    The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
    The variation of body temperature
    The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
    The variation of white blood cell count
    The values 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.
    The variation of hemoglobin
    The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
    The variation of C-reactive protein
    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Full Information

    First Posted
    December 26, 2016
    Last Updated
    February 4, 2020
    Sponsor
    Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03006263
    Brief Title
    Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
    Official Title
    Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fujian Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms
    Keywords
    Stomach Neoplasms, Totally Laparoscopic Total Gastrectomy, Laparoscopy Assisted Total Gastrectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Totally Laparoscopic Total Gastrectomy
    Arm Type
    Experimental
    Arm Description
    Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.
    Arm Title
    Laparoscopy Assisted Total Gastrectomy
    Arm Type
    Experimental
    Arm Description
    Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Totally Laparoscopic Total Gastrectomy
    Intervention Description
    After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopy Assisted Total Gastrectomy
    Intervention Description
    After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
    Primary Outcome Measure Information:
    Title
    overall postoperative morbidity rates
    Description
    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    3-year overall survival rate
    Time Frame
    36 months
    Title
    3-year disease free survival rate
    Time Frame
    36 months
    Title
    3-year recurrence pattern
    Description
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
    Time Frame
    36 months
    Title
    Intraoperative morbidity rates
    Description
    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
    Time Frame
    1 day
    Title
    Time to first ambulation
    Description
    Time to first ambulation in hours is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    Time to first flatus
    Description
    Time to first flatus in days is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    Time to first liquid diet
    Description
    Time to first liquid diet in days is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    Time to first soft diet
    Description
    Time to first soft diet in days is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    Duration of postoperative hospital stay
    Description
    Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    Postoperative pain
    Description
    Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
    Time Frame
    30 days
    Title
    The variation of weight
    Description
    The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
    Time Frame
    3, 6, 9 and 12 months
    Title
    The variation of cholesterol
    Description
    The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
    Time Frame
    3, 6, 9 and 12 months
    Title
    The results of endoscopy
    Description
    The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
    Time Frame
    3 and 12 months
    Title
    The variation of body temperature
    Description
    The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
    Time Frame
    8 days
    Title
    The variation of white blood cell count
    Description
    The values 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 Frame
    Preoperative 3 days and postoperative 1, 3, and 5 days
    Title
    The variation of hemoglobin
    Description
    The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
    Time Frame
    Preoperative 3 days and postoperative 1, 3, and 5 days
    Title
    The variation of C-reactive protein
    Description
    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
    Time Frame
    Preoperative 3 days and postoperative 1, 3, and 5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 to 75 years old Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition） No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent Exclusion Criteria: Pregnant and lactating women Suffering from severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node History of other malignant disease within the past 5 years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within the past 6 months History of cerebrovascular accident within the past 6 months History of continuous systematic administration of corticosteroids within 1 month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changming Huang, Professor
    Organizational Affiliation
    Fujian Medical University Union Hospital,China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

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