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

NCT ID: NCT03599895

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-03-30

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D printing group

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

Group Type: EXPERIMENTAL

3D printing model

Intervention Type: PROCEDURE

Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy

non 3D printing group

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

Group Type: EXPERIMENTAL

non 3D printing model

Intervention Type: PROCEDURE

da Vinci robot assisted radical gastrectomy

Interventions

3D printing model

Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy

Intervention Type: PROCEDURE

non 3D printing model

da Vinci robot assisted radical gastrectomy

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

XJTU1AF-3D-2017-006

Identifier Type: -

Identifier Source: org_study_id