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Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT). (LIV3DPRINT)

Primary Purpose

Liver Diseases, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3D PRINTING
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases focused on measuring complex liver surgery, 3D printing

Eligibility Criteria

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

Inclusion Criteria:

  • Complex liver tumors (bilobar disease, infiltration of suprahepatic veins or requiring two-time resection or intrahepatic vascular reconstruction).
  • Preoperatively was performed, a CT scan and / or MRI of all patients were performed to document the tumor distribution, estimate remaining liver volume, and identify tumor-vessel relationships in order to know the intraoperative vascular anatomy.

Exclusion Criteria:

-

Sites / Locations

  • Clinic and University Virgen de la Arrixaca HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION

Arm Description

Outcomes

Primary Outcome Measures

Surgical planing
Number of Participants susceptible of complex liver surgery as assessed by 3D printing and 3D digital image reconstruction, change from the baseline to the surgical strategy

Secondary Outcome Measures

Teaching for students and residents
Number of students where 3D models of digital printing and images reconstructed in 3D by using a questionnaire improve understanding about the location of lesions, liver anatomy and planning of surgery
Understanding of surgery by the patient
Number of patient who understand better liver disease and surgery strategy

Full Information

First Posted
December 19, 2017
Last Updated
January 30, 2018
Sponsor
Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT03416387
Brief Title
Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT).
Acronym
LIV3DPRINT
Official Title
Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca

4. Oversight

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

5. Study Description

Brief Summary
Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once 3D printers have become more affordable, the true strength of this technique has been recognized because of its ability to obtain anatomical models based on the unique characteristics of each patient. Liver resections are challenging operations because of the complex nature of the liver and venous anatomy within the liver, so 3D imaging is a promising new tool for surgical planning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Surgery
Keywords
complex liver surgery, 3D 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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
3D PRINTING
Intervention Description
A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.
Primary Outcome Measure Information:
Title
Surgical planing
Description
Number of Participants susceptible of complex liver surgery as assessed by 3D printing and 3D digital image reconstruction, change from the baseline to the surgical strategy
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Teaching for students and residents
Description
Number of students where 3D models of digital printing and images reconstructed in 3D by using a questionnaire improve understanding about the location of lesions, liver anatomy and planning of surgery
Time Frame
1 day
Title
Understanding of surgery by the patient
Description
Number of patient who understand better liver disease and surgery strategy
Time Frame
1day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complex liver tumors (bilobar disease, infiltration of suprahepatic veins or requiring two-time resection or intrahepatic vascular reconstruction). Preoperatively was performed, a CT scan and / or MRI of all patients were performed to document the tumor distribution, estimate remaining liver volume, and identify tumor-vessel relationships in order to know the intraoperative vascular anatomy. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Lopez Lopez, FEA
Phone
+34637519516
Email
victorrelopez@gmail.com
Facility Information:
Facility Name
Clinic and University Virgen de la Arrixaca Hospital
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Lopez Lopez

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Good practice principles include: (i) the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (ii) seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (iii) establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD.

Learn more about this trial

Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT).

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