Liver DiseasesLIV3DPRINTNCT03416387
Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery (LIV3DPRINT).
A study testing 3D PRINTING in people with Liver Diseases and Surgery, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once 3D printers have become more affordable, the true strength of this technique has been recognized because of its ability to obtain anatomical models based on the unique characteristics of each patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Surgery
- What is being tested?
- 3D PRINTING
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jun 2017to 1 Jun 2018
- 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
- Complex liver tumors (bilobar disease, infiltration of suprahepatic veins or requiring two-time resection or intrahepatic vascular reconstruction).
- Preoperatively was performed, a CT scan and / or MRI of all patients were performed to document the tumor distribution, estimate remaining liver volume, and identify tumor-vessel relationships in order to know the intraoperative vascular anatomy.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinic and University Virgen de la Arrixaca Hospital
Murcia
Victor Lopez Lopez
About this study
Official title: Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once 3D printers have become more affordable, the true strength of this technique has been recognized because of its ability to obtain anatomical models based on the unique characteristics of each patient. Liver resections are challenging operations because of the complex nature of the liver and venous anatomy within the liver, so 3D imaging is a promising new tool for surgical planning.
- Conditions
- Liver Diseases, Surgery
- Being tested
- 3D PRINTING
- Keywords
- complex liver surgery, 3D printing
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D PRINTINGDevice
A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.
| Study group | Role | What they receive |
|---|---|---|
| OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION | Other | Not described Receives: Device: 3D PRINTING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical planing
Number of Participants susceptible of complex liver surgery as assessed by 3D printing and 3D digital image reconstruction, change from the baseline to the surgical strategy
Measured: 2 weeks
Secondary outcomes (2)
Teaching for students and residents
Number of students where 3D models of digital printing and images reconstructed in 3D by using a questionnaire improve understanding about the location of lesions, liver anatomy and planning of surgery
Measured: 1 day
Understanding of surgery by the patient
Number of patient who understand better liver disease and surgery strategy
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start23 Jun 2017
- Primary completion23 Jun 2017
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Robles Campos, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416387
- Sponsor's protocol ID
- LIV3DPRINT
- Acronym
- LIV3DPRINT
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Good practice principles include: (i) the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (ii) seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (iii) establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Trial of Applicability of 3D Printing and 3D Digital Image Reconstruction in the Planning of Complex Liver Surgery.
- ClinicalTrials.gov ID
- NCT03416387
- Acronym / sponsor ID
- LIV3DPRINT / LIV3DPRINT
- Conditions
- Liver Diseases, Surgery
- Keywords
- complex liver surgery, 3D printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 31 Jan 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.
Three-dimensional (3D) printing has gained popularity in medicine over the last decade. Once 3D printers have become more affordable, the true strength of this technique has been recognized because of its ability to obtain anatomical models based on the unique characteristics of each patient. Liver resections are challenging operations because of the complex nature of the liver and venous anatomy within the liver, so 3D imaging is a promising new tool for surgical planning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION | Other | Device: 3D PRINTING |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complex liver tumors (bilobar disease, infiltration of suprahepatic veins or requiring two-time resection or intrahepatic vascular reconstruction).
- Preoperatively was performed, a CT scan and / or MRI of all patients were performed to document the tumor distribution, estimate remaining liver volume, and identify tumor-vessel relationships in order to know the intraoperative vascular anatomy.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 3D PRINTINGA 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors. | Device | OTHER: 3D PRINTING AND 3D DIGITAL IMAGE RECONSTRUCTION |
Primary outcome
Surgical planing
Time frame: 2 weeks
Number of Participants susceptible of complex liver surgery as assessed by 3D printing and 3D digital image reconstruction, change from the baseline to the surgical strategy
2 secondary outcomes
Teaching for students and residents
Time frame: 1 day
Understanding of surgery by the patient
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: Yes. Good practice principles include: (i) the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access; (ii) seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and (iii) establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D PRINTING in people with Liver Diseases and Surgery, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 2 inclusion and 1 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 31 Jan 2018. 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 Spain. 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?
Contact Victor Lopez Lopez, FEA (+34637519516, victorrelopez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical planing (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2018.