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
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring 3D printing technology
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.
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
NCT ID
NCT03599895
First Posted
July 17, 2018
Last Updated
July 17, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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
Learn more about this trial
Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot
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