Clinical trial NCT03744624: Application of 3D Printing in Laparoscopic Surgery of Liver Tumors
Official title: Application of 3D Printing in Laparoscopic Surgery of Liver Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Hepatocellular Carcinoma
Liver Metastases
Keywords: 3D printing
Liver cancer
Laparoscopic surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of changes in surgery plan
timeFrame: intraoperative
measure: Blood loss
timeFrame: intraoperative
measure: Operative time
timeFrame: intraoperative
Secondary outcomes:
measure: Complications
timeFrame: intraoperative and until discharge, an average of 7 days
measure: Length of stay
timeFrame: until patient discharge, an average of 7 days
measure: Conversion rate
timeFrame: intraoperative
measure: Readmissions
timeFrame: 6 months
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 2nd Department of General Surgery Jagiellonian Univeristy Medical College
state: Małopolskie
Study officials:
References:
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.
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.
citation: 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 observational study. Eur Radiol. 2020 Mar;30(3):1306-1312. doi: 10.1007/s00330-019-06511-2. Epub 2019 Nov 26.