Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Not Applicable

• Conditions: Hepatocellular Carcinoma; Liver Metastases; Liver Cancer
• Interventions: Procedure: Laparoscopic liver resection; Device: 3D printing model

• Registration Number: NCT03744624
• Lead Sponsor: Jagiellonian University

Brief Summary

To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

Detailed Description

Project goal is to evaluate utility of personalized 3D printed models in preoperative planning and performing laparoscopic liver resections. Models will be developed with unique, low-cost approach. Project will consist of three overlapping modules/stages evaluating:

1. Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering

2. Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan

3. Whether 3D printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes

Methodology of developing 3D models is described elsewhere. Printed models will be delivered to surgical team at least 5 days prior to the resection. Surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.

Study Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Age over 18
• Patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions)
• Quality of imaging (CT or MRI or PET (positron emission tomography)/CT) satisfactory to develop 3D models
• Laparoscopic approach
• Informed consent

Exclusion Criteria

• Open approach
• Technical limitations to model development
• No informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
With 3D Model	Laparoscopic liver resection	Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing both 3D printed model and computed tomography (or/and magnetic resonance imaging)
Without 3D Model	Laparoscopic liver resection	Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing only standard medical imaging computed tomography (or/and magnetic resonance imaging) without development of 3D printed model
With 3D Model	3D printing model	Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing both 3D printed model and computed tomography (or/and magnetic resonance imaging)

Primary Outcome Measures

Name	Time	Method
Blood loss	intraoperative
Operative time	intraoperative
Number of changes in surgery plan	intraoperative

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days
Length of stay	until patient discharge, an average of 7 days
Complications	intraoperative and until discharge, an average of 7 days	Number of both total and severe (Clavien-Dindo\>=3) complications
Conversion rate	intraoperative
Readmissions	6 months

Trial Locations

Locations (1)

2nd Department of General Surgery Jagiellonian Univeristy Medical College; 🇵🇱 Kraków, Małopolskie, Poland