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Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery

Primary Purpose

Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D visualization and 3D printing
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases focused on measuring Three-Dimensional Image, Three Dimensional Printing

Eligibility Criteria

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

Inclusion Criteria:

  • the hepatobiliary and pancreatic diseases

Exclusion Criteria:

  • none of the hepatobiliary and pancreatic diseases

Sites / Locations

  • Zhujiang Hospital of The Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3D visualization and 3D printing

Arm Description

From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Outcomes

Primary Outcome Measures

operative time
operative time

Secondary Outcome Measures

intraoperative blood loss
intraoperative blood loss
postoperative complications after surgery
postoperative complications after surgery

Full Information

First Posted
January 29, 2016
Last Updated
March 8, 2017
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03074708
Brief Title
Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery
Official Title
Zhujiang Hospital of the Southern Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Detailed Description
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Pancreatic Diseases, Biliary Tract Diseases
Keywords
Three-Dimensional Image, Three Dimensional Printing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D visualization and 3D printing
Arm Type
Other
Arm Description
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Intervention Type
Other
Intervention Name(s)
3D visualization and 3D printing
Intervention Description
From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
Primary Outcome Measure Information:
Title
operative time
Description
operative time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
intraoperative blood loss
Time Frame
1 year
Title
postoperative complications after surgery
Description
postoperative complications after surgery
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the hepatobiliary and pancreatic diseases Exclusion Criteria: none of the hepatobiliary and pancreatic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chihua Fang, MD
Phone
(+86)2062782568
Email
zjyyfch@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Xiang, MD
Phone
(+86)2062782568
Email
zjyyxn@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, MD
Organizational Affiliation
Zhujiang Hospital of The Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhujiang Hospital of The Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, MD
Phone
(+86)2062782568
Email
zjyyfch@sina.com
First Name & Middle Initial & Last Name & Degree
Nan Xiang, MD
Phone
(+86)2062782568
Email
zjyyxn@126.com
First Name & Middle Initial & Last Name & Degree
Jian Yang, MD
First Name & Middle Initial & Last Name & Degree
Ning Zeng, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery

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