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

Stomach Neoplasms Clinical Trial

— 3DINGCRS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599895
• Other study ID #: XJTU1AF-3D-2017-006
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	record in minutes,from the beginning of anesthesia to the end	1 hours to 6 hours through the surgery completion
Secondary	blood loss	from the surgical record sheet	1 hours to 6 hours through the surgery completion
Secondary	success rate	the time in bed to the postoperative patient	from two days to two weeks after surgery
Secondary	time in bed	the time in bed to the postoperative patient	from two days to two weeks after surgery
Secondary	time to take food	the time to eat to the postoperative patient	from two days to two weeks after surgery
Secondary	postoperative complication rate	including anastomotic stoma fistula,anastomotic stenosis,abdominal	from two weeks to one year after surgery
Secondary	tumor recurrence rate	periodic review the CT or MRI or endoscope	from one month to 2 years after surgery
Secondary	hospitalization expenses	total hospitalization expenses	1 month