Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03744624
• Other study ID #: 122.6120.81.2017
• Secondary ID: 0054/DIA/2018/47
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: December 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatocellular Carcinoma
• Liver Cancer
• Liver Metastases
• Liver Neoplasms

Intervention

Procedure:
• Laparoscopic liver resection
Laparoscopic liver resection for oncological purposes

Device:
• 3D printing model
Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery Jagiellonian Univeristy Medical College	Kraków	Malopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Witowski J, Budzynski A, Grochowska A, Ballard DH, Major P, Rubinkiewicz M, Zlahoda-Huzior A, Popiela TJ, Wierdak M, Pedziwiatr M. Decision-making based on 3D printed models in laparoscopic liver resections with intraoperative ultrasound: a prospective ob — View Citation

Witowski J, Wake N, Grochowska A, Sun Z, Budzynski A, Major P, Popiela TJ, Pedziwiatr M. Investigating accuracy of 3D printed liver models with computed tomography. Quant Imaging Med Surg. 2019 Jan;9(1):43-52. doi: 10.21037/qims.2018.09.16. — View Citation

Witowski JS, Pedziwiatr M, Major P, Budzynski A. Cost-effective, personalized, 3D-printed liver model for preoperative planning before laparoscopic liver hemihepatectomy for colorectal cancer metastases. Int J Comput Assist Radiol Surg. 2017 Dec;12(12):2047-2054. doi: 10.1007/s11548-017-1527-3. Epub 2017 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of changes in surgery plan		intraoperative
Primary	Blood loss		intraoperative
Primary	Operative time		intraoperative
Secondary	Complications	Number of both total and severe (Clavien-Dindo>=3) complications	intraoperative and until discharge, an average of 7 days
Secondary	Length of stay		until patient discharge, an average of 7 days
Secondary	Conversion rate		intraoperative
Secondary	Readmissions		6 months
Secondary	Mortality		90 days