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Clinical Trials/NCT03416387
NCT03416387
Unknown
Not Applicable

Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.

Hospital Universitario Virgen de la Arrixaca1 site in 1 country20 target enrollmentJune 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Diseases
Sponsor
Hospital Universitario Virgen de la Arrixaca
Enrollment
20
Locations
1
Primary Endpoint
Surgical planing
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2017
End Date
June 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital Universitario Virgen de la Arrixaca
Responsible Party
Principal Investigator
Principal Investigator

Ricardo Robles Campos

Profesor

Hospital Universitario Virgen de la Arrixaca

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

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Understanding of surgery by the patient(1day)
  • Teaching for students and residents(1 day)

Study Sites (1)

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