Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Jagiellonian University

Status: Active, not recruiting

Conditions: Liver Metastases; Hepatocellular Carcinoma; Liver Cancer

Treatments: Procedure: Laparoscopic liver resection; Device: 3D printing model

Study type: Interventional

Funder types: Other

Identifiers

NCT03744624

122.6120.81.2017

0054/DIA/2018/47 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

With 3D Model

Experimental group

Description:

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)

Treatment:

Procedure: Laparoscopic liver resection

Device: 3D printing model

Without 3D Model

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic liver resection