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Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

Primary Purpose

Stomach Neoplasms

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
D2 lymphadenectomy including No. 14v
lymphadenectomy excluding No. 14v
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

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

Inclusion Criteria:• Age from 18 to 75 years

  • Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4a, N0-3, 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)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node envelop important vessels
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • 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 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    D2 Lymphadenectomy including No. 14v

    D2 lymphadenectomy excluding No. 14v

    Arm Description

    Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group

    Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group

    Outcomes

    Primary Outcome Measures

    3-year disease overall survival rate

    Secondary Outcome Measures

    No.14v Lymph node metastasis rate
    Morbidity and mortality
    The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
    3-year 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
    Time to first ambulation
    The data of postoperative recovery course.
    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 liquid diet
    Time to soft diet
    Duration of hospital stay
    The amount of abdominal drainage
    Blood transfusion
    The number of positive lymph nodes
    Intraoperative lymph node dissection time
    intraoperative No.14v lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node
    Intraoperative blood loss
    Intraoperative injury
    The amount of use of titanium clip
    The rate of conversion to laparotomy
    The variation of cholesterol
    The variation of cholesterol on postoperative 3, 6, 9 and 12 months
    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
    and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    The values of C-reactive protein
    and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    The values of prealbumin
    and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    The values of relevant immune cytokines
    and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Visual Analog Score for pain
    the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.
    EORTC QLQ-C30 and QLQ - STO22
    European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.

    Full Information

    First Posted
    May 29, 2016
    Last Updated
    February 4, 2020
    Sponsor
    Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02789891
    Brief Title
    Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection
    Official Title
    Randomized Controlled Trials on Laparoscopic No. 14v Lymph Node Dissection for Advanced Lower Third Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.
    Detailed Description
    A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are 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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    326 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    D2 Lymphadenectomy including No. 14v
    Arm Type
    Experimental
    Arm Description
    Laparoscopic distal gastrectomy with D2 lymphadenectomy including No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group
    Arm Title
    D2 lymphadenectomy excluding No. 14v
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v lymph node dissection will be performed for the treatment of patients assigned to this group
    Intervention Type
    Procedure
    Intervention Name(s)
    D2 lymphadenectomy including No. 14v
    Intervention Description
    After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection 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)
    lymphadenectomy excluding No. 14v
    Intervention Description
    After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection 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
    3-year disease overall survival rate
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    No.14v Lymph node metastasis rate
    Time Frame
    10 days
    Title
    Morbidity and mortality
    Description
    The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
    Time Frame
    30 days; 36 months
    Title
    3-year 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
    Time to first ambulation
    Description
    The data of postoperative recovery course.
    Time Frame
    10 days
    Title
    The number of lymph node dissection
    Time Frame
    10day
    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 day
    Title
    Time to first flatus
    Time Frame
    10 days
    Title
    Time to first liquid diet
    Time Frame
    10 days
    Title
    Time to soft diet
    Time Frame
    10 days
    Title
    Duration of hospital stay
    Time Frame
    10 days
    Title
    The amount of abdominal drainage
    Time Frame
    10 days
    Title
    Blood transfusion
    Time Frame
    10 days
    Title
    The number of positive lymph nodes
    Time Frame
    1 day
    Title
    Intraoperative lymph node dissection time
    Description
    intraoperative No.14v lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node
    Time Frame
    1 day
    Title
    Intraoperative blood loss
    Time Frame
    1 day
    Title
    Intraoperative injury
    Time Frame
    1 day
    Title
    The amount of use of titanium clip
    Time Frame
    1 day
    Title
    The rate of conversion to laparotomy
    Time Frame
    1 day
    Title
    The variation of cholesterol
    Description
    The variation of cholesterol on postoperative 3, 6, 9 and 12 months
    Time Frame
    12 months
    Title
    The variation of albumin
    Description
    The variation of albumin on postoperative 3, 6, 9 and 12 months
    Time Frame
    12 months
    Title
    The results of endoscopy
    Description
    the results of endoscopy on postoperative 3 and 12 months
    Time Frame
    12 months
    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
    and 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
    and 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
    and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Time Frame
    7 days
    Title
    The values of relevant immune cytokines
    Description
    and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
    Time Frame
    7 days
    Title
    Visual Analog Score for pain
    Description
    the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.
    Time Frame
    7 days
    Title
    EORTC QLQ-C30 and QLQ - STO22
    Description
    European Organization fo Research and Treatment(EORTC) QLQ-C30 and QLQ - STO22 before operation and on postoperative month 6,12,36 are recorded.
    Time Frame
    Time Frame: 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:• Age from 18 to 75 years Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, 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) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node envelop important vessels History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy 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

    Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

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