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The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
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, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • History of other malignant disease within past five years
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Laparoscopic-assisted Gastrectomy

    Arm Description

    Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group

    Outcomes

    Primary Outcome Measures

    Morbidity
    The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system

    Secondary Outcome Measures

    Pathological response
    Pathological response grading was performed according to the Becker TRG system
    Radiological response
    Radiological response and progression were assessed according to RECIST version 1.1
    3-year disease free survival rate
    3-year disease free survival rate
    3-year overall survival rate
    3-year overall 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
    Mortality
    The early mortality are defined as the event observed within 30 days after surgery.
    Time to first ambulation
    The data of postoperative recovery course
    Rates of combined organ resection
    Combined organ resection performing by severe injury or abdominal adhesions
    The number of lymph node dissection
    The number of lymph node dissection
    The variation of weight
    The variation of weight on postoperative 3, 6, 9 and 12 months
    The daily highest body temperature
    The daily highest body temperature before discharge
    Time to first flatus
    Time to first flatus
    Time to first liquid diet
    Time to first liquid diet
    Time to soft diet
    Time to soft diet
    Scale the amount of abdominal drainage
    Scale the amount of abdominal drainage
    Blood transfusion
    Blood transfusion
    The number of positive lymph nodes
    The number of positive lymph nodes
    Intraoperative lymph node dissection time
    intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis.
    Intraoperative blood loss
    Intraoperative blood loss
    Time of operation
    Time of operation
    Intraoperative injury
    Intraoperative injury
    The amount of use of titanium clip
    The amount of use of titanium clip
    The rate of conversion to laparotomy
    The rate of conversion to laparotomy
    The variation of albumin
    The variation of albumin on postoperative 3, 6, 9 and 12 months
    The results of endoscopy
    the results of endoscopy on postoperative 3 and 12 months
    The values 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
    The values of hemoglobin
    the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    The values of C-reactive protein
    the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    The values of prealbumin
    the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Duration of hospital stay
    Duration of hospital stay
    Late postoperative complication
    The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th.
    Adverse events
    Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

    Full Information

    First Posted
    September 11, 2016
    Last Updated
    January 22, 2021
    Sponsor
    Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02902575
    Brief Title
    The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
    Official Title
    The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    October 31, 2019 (Actual)
    Study Completion Date
    November 30, 2019 (Actual)

    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 the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.
    Detailed Description
    A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms
    Keywords
    Stomach Neoplasms, Laparoscopy, Advanced Gastric Cancer, Neoadjuvant Chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Laparoscopic-assisted Gastrectomy
    Arm Type
    Experimental
    Arm Description
    Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic-assisted gastrectomy with D2 lymphadenectomy
    Intervention Description
    After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
    Primary Outcome Measure Information:
    Title
    Morbidity
    Description
    The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Pathological response
    Description
    Pathological response grading was performed according to the Becker TRG system
    Time Frame
    30 days
    Title
    Radiological response
    Description
    Radiological response and progression were assessed according to RECIST version 1.1
    Time Frame
    30 days
    Title
    3-year disease free survival rate
    Description
    3-year disease free survival rate
    Time Frame
    36 months
    Title
    3-year overall survival rate
    Description
    3-year overall 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
    Mortality
    Description
    The early mortality are defined as the event observed within 30 days after surgery.
    Time Frame
    30 days
    Title
    Time to first ambulation
    Description
    The data of postoperative recovery course
    Time Frame
    10 days
    Title
    Rates of combined organ resection
    Description
    Combined organ resection performing by severe injury or abdominal adhesions
    Time Frame
    1 day
    Title
    The number of lymph node dissection
    Description
    The number of lymph node dissection
    Time Frame
    1 day
    Title
    The variation of weight
    Description
    The variation of weight on postoperative 3, 6, 9 and 12 months
    Time Frame
    12 months
    Title
    The daily highest body temperature
    Description
    The daily highest body temperature before discharge
    Time Frame
    7 days
    Title
    Time to first flatus
    Description
    Time to first flatus
    Time Frame
    10 days
    Title
    Time to first liquid diet
    Description
    Time to first liquid diet
    Time Frame
    10 days
    Title
    Time to soft diet
    Description
    Time to soft diet
    Time Frame
    10 days
    Title
    Scale the amount of abdominal drainage
    Description
    Scale the amount of abdominal drainage
    Time Frame
    10 days
    Title
    Blood transfusion
    Description
    Blood transfusion
    Time Frame
    10 days
    Title
    The number of positive lymph nodes
    Description
    The number of positive lymph nodes
    Time Frame
    1 days
    Title
    Intraoperative lymph node dissection time
    Description
    intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node and jejunal lymph nodes adjacent to the anastomosis.
    Time Frame
    1 days
    Title
    Intraoperative blood loss
    Description
    Intraoperative blood loss
    Time Frame
    1 days
    Title
    Time of operation
    Description
    Time of operation
    Time Frame
    1 day
    Title
    Intraoperative injury
    Description
    Intraoperative injury
    Time Frame
    1 days
    Title
    The amount of use of titanium clip
    Description
    The amount of use of titanium clip
    Time Frame
    1 days
    Title
    The rate of conversion to laparotomy
    Description
    The rate of conversion to laparotomy
    Time Frame
    1 days
    Title
    The variation of albumin
    Description
    The variation of albumin on postoperative 3, 6, 9 and 12 months
    Time Frame
    12 month
    Title
    The results of endoscopy
    Description
    the results of endoscopy on postoperative 3 and 12 months
    Time Frame
    12 month
    Title
    The values 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
    Time Frame
    7 days
    Title
    The values of hemoglobin
    Description
    the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Time Frame
    7 days
    Title
    The values of C-reactive protein
    Description
    the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Time Frame
    7 days
    Title
    The values of prealbumin
    Description
    the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Time Frame
    7 days
    Title
    Duration of hospital stay
    Description
    Duration of hospital stay
    Time Frame
    10 days
    Title
    Late postoperative complication
    Description
    The late postoperative complication was defined as the event observed within the period from postoperative day 31th to the end of month 36th.
    Time Frame
    36 months
    Title
    Adverse events
    Description
    Adverse events (AEs) of neoadjuvant chemotherapy were assessed at each visit per the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
    Time Frame
    30 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 from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection History of other malignant disease within past five years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values

    12. IPD Sharing Statement

    Learn more about this trial

    The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy

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