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Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot (3DINGCRS)

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D printing model
non 3D printing model
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring 3D printing technology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients without contraindications gastroscope,surgery and anesthesia;
  • There is no history of abdominal surgery, no severe abdominal cavity adhesion;
  • Not found the tumor metastasis;
  • Normal coagulation function;
  • There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
  • Patients and their families volunteered choice the surgical procedure and signed informed consent.

Exclusion Criteria:

  • Patients with preoperative assessment of distant metastasis;
  • Patients with preoperative radiation and chemotherapy or hormone therapy;
  • Patients with acute obstruction, bleeding or perforation of the emergency surgery;
  • Patients with a history of abdominal trauma or abdominal surgery;
  • Patients with contraindications gastroscope,surgery and anesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    3D printing group

    non 3D printing group

    Arm Description

    the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model

    the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model

    Outcomes

    Primary Outcome Measures

    operation time
    record in minutes,from the beginning of anesthesia to the end

    Secondary Outcome Measures

    blood loss
    from the surgical record sheet
    success rate
    the time in bed to the postoperative patient
    time in bed
    the time in bed to the postoperative patient
    time to take food
    the time to eat to the postoperative patient
    postoperative complication rate
    including anastomotic stoma fistula,anastomotic stenosis,abdominal
    tumor recurrence rate
    periodic review the CT or MRI or endoscope
    hospitalization expenses
    total hospitalization expenses

    Full Information

    First Posted
    July 17, 2018
    Last Updated
    July 17, 2018
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03599895
    Brief Title
    Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot
    Acronym
    3DINGCRS
    Official Title
    Combined Application of 3D Printing Technology and Robotic Surgery in Radical Gastrectomy of Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    March 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.
    Detailed Description
    The investigators will work with general surgery, imaging department and 3D printing center to try to print gastric cancer model and guide the operation. After obtaining the approval of the Hospital Ethics Committee, 20 patients with gastric cancer were collected for imaging examination and evaluation, and the normal physical model of 70% normal volume was printed with Guang Min resin material.The investigators will analyse the anatomical relationship between the tumor and surrounding tissues,and determine the range of tumor excision and the feasibility and safety of radical gastrectomy with Leonardo da Vinci robot for gastric cancer.Through the assistance of the 3D model,The investigators will select the suitable operation path to determine the extent of tumor excision and lymph node dissection.Furthermore, 3D print model is used to provide real-time navigation for key steps of surgery. The purpose of this research is to observe the application value of 3D printing technique in gastric cancer laparoscopic surgery with Leonardo da Vinci robot radical gastrectomy, and to provide reference for the development of 3D printing model of other complicated digestive tract surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms
    Keywords
    3D printing technology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3D printing group
    Arm Type
    Experimental
    Arm Description
    the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model
    Arm Title
    non 3D printing group
    Arm Type
    Experimental
    Arm Description
    the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model
    Intervention Type
    Procedure
    Intervention Name(s)
    3D printing model
    Intervention Description
    Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    non 3D printing model
    Intervention Description
    da Vinci robot assisted radical gastrectomy
    Primary Outcome Measure Information:
    Title
    operation time
    Description
    record in minutes,from the beginning of anesthesia to the end
    Time Frame
    1 hours to 6 hours through the surgery completion
    Secondary Outcome Measure Information:
    Title
    blood loss
    Description
    from the surgical record sheet
    Time Frame
    1 hours to 6 hours through the surgery completion
    Title
    success rate
    Description
    the time in bed to the postoperative patient
    Time Frame
    from two days to two weeks after surgery
    Title
    time in bed
    Description
    the time in bed to the postoperative patient
    Time Frame
    from two days to two weeks after surgery
    Title
    time to take food
    Description
    the time to eat to the postoperative patient
    Time Frame
    from two days to two weeks after surgery
    Title
    postoperative complication rate
    Description
    including anastomotic stoma fistula,anastomotic stenosis,abdominal
    Time Frame
    from two weeks to one year after surgery
    Title
    tumor recurrence rate
    Description
    periodic review the CT or MRI or endoscope
    Time Frame
    from one month to 2 years after surgery
    Title
    hospitalization expenses
    Description
    total hospitalization expenses
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients without contraindications gastroscope,surgery and anesthesia; There is no history of abdominal surgery, no severe abdominal cavity adhesion; Not found the tumor metastasis; Normal coagulation function; There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week; Patients and their families volunteered choice the surgical procedure and signed informed consent. Exclusion Criteria: Patients with preoperative assessment of distant metastasis; Patients with preoperative radiation and chemotherapy or hormone therapy; Patients with acute obstruction, bleeding or perforation of the emergency surgery; Patients with a history of abdominal trauma or abdominal surgery; Patients with contraindications gastroscope,surgery and anesthesia.

    12. IPD Sharing Statement

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    Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot

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