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Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D Laparoscopic Surgery
2D Laparoscopic Surgery
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stomach Neoplasms focused on measuring Stomach Neoplasms Laparoscopy

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1)Age from over 19 to under 74 years
  • (2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • (3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
  • (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
  • (5)American Society of Anesthesiology (ASA) score class I, II, or III
  • (6)Written informed consent

Exclusion Criteria:

  • (1)Women during pregnancy or breast-feeding
  • (2)Severe mental disorder
  • (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
  • (5)History of unstable angina or myocardial infarction within past six months
  • (6)History of cerebrovascular accident within past six months
  • (7)History of continuous systematic administration of corticosteroids within one month
  • (8)History of previous neoadjuvant chemotherapy or radiotherapy
  • (9)T4b tumors
  • (10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • (11)FEV1(Forced expiratory volume in one second)<50% of predicted values

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    3D Laparoscopic Surgery

    2D Laparoscopic Surgery

    Arm Description

    3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

    2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.

    Outcomes

    Primary Outcome Measures

    Operating time
    Operating time

    Secondary Outcome Measures

    Intraoperative situation
    The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy
    Postoperative recovery course
    Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
    Complication
    Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome
    The postoperative pathology
    The postoperative pathological type and pTNM stage.
    Inflammatory and immune response
    The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and 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.
    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.
    Hospitalization expenses
    The cost from admission to discharge
    3-year disease free survival rate
    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
    3-year overall survival rate
    Overall survival was defined as the time from surgery to death from any cause
    5-year disease free survival rate
    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
    5-year overall survival rate
    Overall survival was defined as the time from surgery to death from any cause
    Recurrence patterns
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

    Full Information

    First Posted
    December 24, 2014
    Last Updated
    April 5, 2023
    Sponsor
    Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02327481
    Brief Title
    Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
    Official Title
    Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    April 26, 2016 (Actual)
    Study Completion Date
    April 26, 2021 (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 feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.
    Detailed Description
    A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    438 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3D Laparoscopic Surgery
    Arm Type
    Experimental
    Arm Description
    3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
    Arm Title
    2D Laparoscopic Surgery
    Arm Type
    Active Comparator
    Arm Description
    2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
    Intervention Type
    Procedure
    Intervention Name(s)
    3D Laparoscopic Surgery
    Intervention Description
    After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic 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)
    2D Laparoscopic Surgery
    Intervention Description
    After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic 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
    Operating time
    Description
    Operating time
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Intraoperative situation
    Description
    The number of lymph node dissection, the number of positive lymph nodes, intraoperative lymph node dissection time(regional analysis: infrapyloric area lymph node, suprapancreatic area lymph node, splenic hilar area lymph node, cardial area lymph node), intracavitary anastomosis time(patients who undergo totally laparoscopic surgery are analyzed), intraoperative blood loss, intraoperative injury, the amount of use of titanium clip, the rate of conversion to laparotomy
    Time Frame
    1 day
    Title
    Postoperative recovery course
    Description
    Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
    Time Frame
    10 days
    Title
    Complication
    Description
    Early complications occurred within 30 days after operation: pulmonary infection, incision complication, intestinal obstruction, abdominal infection, anastomotic bleeding, anastomotic fistula, gastric emptying; Long-term complications (30 days later after operation): anastomotic stenosis, intestinal obstruction, dumping syndrome
    Time Frame
    30 days;36 months
    Title
    The postoperative pathology
    Description
    The postoperative pathological type and pTNM stage.
    Time Frame
    7 days
    Title
    Inflammatory and immune response
    Description
    The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and 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
    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
    Hospitalization expenses
    Description
    The cost from admission to discharge
    Time Frame
    1 months
    Title
    3-year disease free survival rate
    Description
    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
    Time Frame
    36 months
    Title
    3-year overall survival rate
    Description
    Overall survival was defined as the time from surgery to death from any cause
    Time Frame
    36 months
    Title
    5-year disease free survival rate
    Description
    Disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
    Time Frame
    60 months
    Title
    5-year overall survival rate
    Description
    Overall survival was defined as the time from surgery to death from any cause
    Time Frame
    60 months
    Title
    Recurrence patterns
    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
    60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1)Age from over 19 to under 74 years (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs (5)American Society of Anesthesiology (ASA) score class I, II, or III (6)Written informed consent Exclusion Criteria: (1)Women during pregnancy or breast-feeding (2)Severe mental disorder (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy) (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels (5)History of unstable angina or myocardial infarction within the past six months (6)History of cerebrovascular accident within the past six months (7)History of continuous systematic administration of corticosteroids within one month (8)History of previous neoadjuvant chemotherapy or radiotherapy (9)T4b tumors (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer (11)FEV1(Forced expiratory volume in one second)<50% of predicted values
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changming Huang, M.D.,Ph.D.
    Organizational Affiliation
    Fujian Medical University Union Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31521128
    Citation
    Lu J, Xu Y, Wu Y, Huang XY, Xie JW, Wang JB, Lin JX, Li P, Zheng CH, Huang AM, Huang CM. Tumor-infiltrating CD8+ T cells combined with tumor-associated CD68+ macrophages predict postoperative prognosis and adjuvant chemotherapy benefit in resected gastric cancer. BMC Cancer. 2019 Sep 14;19(1):920. doi: 10.1186/s12885-019-6089-z.
    Results Reference
    derived
    PubMed Identifier
    30809728
    Citation
    Liu ZY, Chen QY, Zhong Q, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Zheng CH, Huang CM, Li P. Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study. Surg Endosc. 2019 Oct;33(10):3425-3435. doi: 10.1007/s00464-018-06640-7. Epub 2019 Feb 26.
    Results Reference
    derived
    PubMed Identifier
    30739259
    Citation
    Xu BB, Lu J, Zheng ZF, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng CH, Huang CM, Li P. The predictive value of the preoperative C-reactive protein-albumin ratio for early recurrence and chemotherapy benefit in patients with gastric cancer after radical gastrectomy: using randomized phase III trial data. Gastric Cancer. 2019 Sep;22(5):1016-1028. doi: 10.1007/s10120-019-00936-w. Epub 2019 Feb 9.
    Results Reference
    derived
    PubMed Identifier
    29195739
    Citation
    Zheng CH, Lu J, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial. Surgery. 2018 Feb;163(2):300-304. doi: 10.1016/j.surg.2017.09.053. Epub 2017 Nov 28.
    Results Reference
    derived
    PubMed Identifier
    27826781
    Citation
    Lu J, Zheng CH, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report. Surg Endosc. 2017 Jul;31(7):2939-2945. doi: 10.1007/s00464-016-5310-2. Epub 2016 Nov 8.
    Results Reference
    derived

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