Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT).
LIV3DPRINT
Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJanuary 31, 2018
January 1, 2018
Same day
December 19, 2017
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 weeks
Secondary Outcomes (2)
Teaching for students and residents
1 day
Understanding of surgery by the patient
1day
Study Arms (1)
OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION
OTHERInterventions
A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic and University Virgen de la Arrixaca Hospital
Murcia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profesor
Study Record Dates
First Submitted
December 19, 2017
First Posted
January 31, 2018
Study Start
June 23, 2017
Primary Completion
June 23, 2017
Study Completion
June 1, 2018
Last Updated
January 31, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
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.