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

July 17, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

Combined Application of 3D Printing Technology and Robotic Surgery in Radical Gastrectomy of Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printing group
the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model
Procedure: 3D printing model
Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy
Experimental: non 3D printing group
the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model
Procedure: non 3D printing model
da Vinci robot assisted radical gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
1 hours to 6 hours through the surgery completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 1 hours to 6 hours through the surgery completion
from the surgical record sheet
1 hours to 6 hours through the surgery completion
success rate
Time Frame: from two days to two weeks after surgery
the time in bed to the postoperative patient
from two days to two weeks after surgery
time in bed
Time Frame: from two days to two weeks after surgery
the time in bed to the postoperative patient
from two days to two weeks after surgery
time to take food
Time Frame: from two days to two weeks after surgery
the time to eat to the postoperative patient
from two days to two weeks after surgery
postoperative complication rate
Time Frame: from two weeks to one year after surgery
including anastomotic stoma fistula,anastomotic stenosis,abdominal
from two weeks to one year after surgery
tumor recurrence rate
Time Frame: from one month to 2 years after surgery
periodic review the CT or MRI or endoscope
from one month to 2 years after surgery
hospitalization expenses
Time Frame: 1 month
total hospitalization expenses
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 30, 2020

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-3D-2017-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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