Liver CancerNCT03744624
Application of 3D Printing in Laparoscopic Surgery of Liver Tumors
A study testing Laparoscopic liver resection and 3D printing model in people with Liver Cancer and Hepatocellular Carcinoma, run by Jagiellonian University at 1 site in Poland.
Trial summary
To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma, Liver Metastases
- What is being tested?
- Laparoscopic liver resection and 3D printing model
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 sitePoland
- Study dates
- 28 Apr 2017to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Open approach
- Technical limitations to model development
- No informed consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of General Surgery Jagiellonian Univeristy Medical College
Krakow, Lesser Poland Voivodeship, 31-501
About this study
To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.
Read the 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:
- Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering
- Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan
- 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.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Liver Metastases
- Being tested
- Laparoscopic liver resection, 3D printing model
- Keywords
- 3D printing, Liver cancer, Laparoscopic surgery
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver resectionProcedure or surgery
Laparoscopic liver resection for oncological purposes
3D printing modelDevice
Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.
| Study group | Role | What they receive |
|---|---|---|
| With 3D Model | Experimental | 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) Receives: Procedure: Laparoscopic liver resection; Device: 3D printing model |
| Without 3D Model | Active comparator | 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 Receives: Procedure: Laparoscopic liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of changes in surgery plan
Measured: intraoperative
Blood loss
Measured: intraoperative
Operative time
Measured: intraoperative
Secondary outcomes (5)
Complications
Number of both total and severe (Clavien-Dindo>=3) complications
Measured: intraoperative and until discharge, an average of 7 days
Length of stay
Measured: until patient discharge, an average of 7 days
Conversion rate
Measured: intraoperative
Readmissions
Measured: 6 months
Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start28 Apr 2017
- Primary completion1 Jun 2022
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Witowski, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744624
- Sponsor's protocol ID
- 122.6120.81.2017
- Other IDs
- 0054/DIA/2018/47
- Status last verified
- Aug 2022
- First submitted
- 13 Nov 2018
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28144830Witowski 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.
PubMed 30788245Witowski 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.
PubMed 31773294
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing in Laparoscopic Surgery of Liver Tumors
- ClinicalTrials.gov ID
- NCT03744624
- Acronym / sponsor ID
- 122.6120.81.2017
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Liver Metastases
- Keywords
- 3D printing, Liver cancer, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering
- Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With 3D Model | Experimental | Procedure: Laparoscopic liver resection, Device: 3D printing modelPatients 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 | Active comparator | Procedure: Laparoscopic liver resectionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Open approach
- Technical limitations to model development
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic liver resectionLaparoscopic liver resection for oncological purposes | Procedure or surgery | With 3D Model, Without 3D Model |
| 3D printing modelUse of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance. | Device | With 3D Model |
Primary outcome
Number of changes in surgery plan
Time frame: intraoperative
Blood loss
Time frame: intraoperative
Operative time
Time frame: intraoperative
5 secondary outcomes
Complications
Time frame: intraoperative and until discharge, an average of 7 days
Length of stay
Time frame: until patient discharge, an average of 7 days
Conversion rate
Time frame: intraoperative
Readmissions
Time frame: 6 months
Mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 28144830Witowski 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.
- Results publication: PubMed 30788245Witowski 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.
- Results publication: PubMed 31773294Witowski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic liver resection and 3D printing model in people with Liver Cancer and Hepatocellular Carcinoma, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of changes in surgery plan (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.