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

Not Applicable

• Conditions: Liver Diseases; Surgery
• Interventions: Device: 3D PRINTING

• Registration Number: NCT03416387
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-23
• Primary Completion: 2017-06-23
• Study First Submitted: 2017-12-19
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-30
• Last Update Submitted: 2018-01-30
• Study First Posted: 2018-01-31
• Last Update Posted: 2018-01-31
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION	3D PRINTING	-

Primary Outcome Measures

Name	Time	Method
Surgical planing	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

Name	Time	Method
Understanding of surgery by the patient	1day	Number of patient who understand better liver disease and surgery strategy
Teaching for students and residents	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

Trial Locations

Locations (1)

Clinic and University Virgen de la Arrixaca Hospital; 🇪🇸 Murcia, Spain