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

Surgery Clinical Trial

— LIV3DPRINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416387
• Other study ID #: LIV3DPRINT
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2017
• Last updated: January 30, 2018
• Start date: June 23, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: January 2018
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: Victor Lopez Lopez, FEA
• Phone: +34637519516
• Email: victorrelopez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2018
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Liver Diseases
• Surgery

Intervention

Device:
• 3D PRINTING
A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.

Locations

Country	Name	City	State
Spain	Clinic and University Virgen de la Arrixaca Hospital	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 day
Secondary	Understanding of surgery by the patient	Number of patient who understand better liver disease and surgery strategy	1day