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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416387
Recruitment Status : Unknown
Verified January 2018 by Ricardo Robles Campos, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Robles Campos, Hospital Universitario Virgen de la Arrixaca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Diseases Surgery Device: 3D PRINTING Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : June 23, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION Device: 3D PRINTING
A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.


Outcome Measures
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Primary Outcome Measures :
  1. Surgical planing [ Time Frame: 2 weeks ]
    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 :
  1. Teaching for students and residents [ Time Frame: 1 day ]
    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

  2. Understanding of surgery by the patient [ Time Frame: 1day ]
    Number of patient who understand better liver disease and surgery strategy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416387


Contacts
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Contact: Victor Lopez Lopez, FEA +34637519516 victorrelopez@gmail.com

Locations
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Spain
Clinic and University Virgen de la Arrixaca Hospital Recruiting
Murcia, Spain
Contact: Victor Lopez Lopez         
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
More Information
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Responsible Party: Ricardo Robles Campos, Profesor, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT03416387    
Other Study ID Numbers: LIV3DPRINT
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ricardo Robles Campos, Hospital Universitario Virgen de la Arrixaca:
complex liver surgery
3D printing
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases