Pulmonary Malformation3DLPNCT03913416
Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection
A study testing 3D printed model in people with Pulmonary Malformation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The National Rare Diseases plans, the ongoing MALFPULM PHRC and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. The resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to… Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Pulmonary Malformation
- What is being tested?
- 3D printed model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2020to Sep 2024
- 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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged from 1 day to 24 months.
- Patients with pulmonary malformation eligible for surgery
- Parents agreement for surgical treatment
- Parents able to sign an informed consent form
- Patient benefiting from a social insurance system or a similar system
Who cannot join
- Emergency surgeries (less than 15 days between scanner and surgery)
- Obvious extrapulmonary sequestration on tomographic scanning images
- Patients with other major malformation additionally to pulmonary malformation
- Parents unable to understand the purpose of the trial
- Patient already participating to another clinical trial that might jeopardize the current trial
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Femme Mere Enfant
Bron
Frederic Hameury, MD, 4 27 85 57 89 ext. +33
About this study
The National Rare Diseases plans, the ongoing MALFPULM PHRC and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. The resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to avoid exceptional tumors. Procedures are ideally performed around the age of 5-6 months to take advantage of the lung growth that continues during the first two years of life. The surgical strategies depend of the malformation size, the tumor risk and surgeon choice: conservative surgery with removal of part of the lobe may be preferred over complete resection of the concerned lobe.
If possible, thoracoscopic resection is carried out. The open thoracotomy is more painful and leads to complications such as thoracic deformities, larger scars, blood loss. However, in infants the thoracoscopic work space is small, lung exclusion is challenging and the anatomy (normal or malformative) is difficult to understand in space. The rate of thoracoscopy without conversion to thoracotomy ranges from 98% in one American center with a more radical approach , to 48% in a national cohort. Pulmonary exclusion failure, complexity and size of malformations and intra-operative complications are factors of conversion to thoracotomy . These factors can lead surgeons to perform thoracotomy without attempting thoracoscopy.
3D printing is a thriving research field for its educational or therapeutic potential optimization of management, prosthesis, and organ replacement. 3D printing is particularly adapted to pediatrics, which suffers from the rarity of its pathologies and a large spectrum of size and morphology prohibiting the mass production of models. 3D printing models of complex pulmonary pathologies will allowed for a better anesthetic and surgical approach. The modeling of bronchial, vascular and even parenchymatous anatomy permits a better understanding of the anatomical particularities of each patient. This, in turn, avoids the intra-operative conversions to thoracotomy with a direct benefit for the patient.
- Conditions
- Pulmonary Malformation
- Being tested
- 3D printed model, Control group
- Keywords
- pulmonary malformation, 3D printed models, thoracotomy, thoracoscopy children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed modelDevice
Before surgery, the surgeon will have a 3D printed model of the pulmonary malformation as well as the lung, the rib cage and the tracheal trunk based on the initial scanner images. He will then be able to train and plan the surgical strategy, as well as to discuss the pulmonary exclusion with the anesthetist.
Control groupOther
The control group is composed of patients operated with standard surgery
| Study group | Role | What they receive |
|---|---|---|
| 3D | Experimental | Surgery with surgeon trained using a 3D printed model of the pulmonary malformation. Receives: Device: 3D printed model |
| Control group | Other | Conventional surgery without training using a 3D printed model of the pulmonary malformation. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of intent to treat under thoracoscopy vs thoracotomy procedures
Comparisonbetween the 2 groups.
Measured: Day 1
Secondary outcomes (18)
conversion rate from thoracoscopy over thoracoscopy attempted.
Comparison between the 2 groups.
Measured: Day 1
Proportion of effective pulmonary exclusion of the operated lung.
Measured: Day 1
Proportion of variation between preoperative and effective strategy
Variation of strategy in terms of type of resection (lobar, sub-lobar or segmental resection)
Measured: Day 1
induction time
Comparison of induction time in minutes between the 2 strategies
Measured: Day 1
Evaluation of pain using EVENDOL scale
Comparison of pain between the 2 groups. Total EVENDOL scores vary from 0 (min) to 15 (max). Each item is scored from 0 to 3 0 = No sign, normal
- = weak or transient sign
- = moderate or only present half the time
- = strong or almost permanent sign
Measured: Hour 12
Evaluation of pain using EVENDOL scale
Comparison of pain between the 2 groups. Total EVENDOL scores vary from 0 (min) to 15 (max). Each item is scored from 0 to 3 0 = No sign, normal
- = weak or transient sign
- = moderate or only present half the time
- = strong or almost permanent sign
Measured: Hour 24
Evaluation of pain using EVENDOL scale
Comparison of pain between the 2 groups. Total EVENDOL scores vary from 0 (min) to 15 (max). Each item is scored from 0 to 3 0 = No sign, normal
- = weak or transient sign
- = moderate or only present half the time
- = strong or almost permanent sign
Measured: Hour 36
Evaluation of pain using EVENDOL scale
Comparison of pain between the 2 groups. Total EVENDOL scores vary from 0 (min) to 15 (max). Each item is scored from 0 to 3 0 = No sign, normal
- = weak or transient sign
- = moderate or only present half the time
- = strong or almost permanent sign
Measured: Hour 48
Evaluation of pain using EVENDOL scale
Comparison of pain between the 2 groups. Total EVENDOL scores vary from 0 (min) to 15 (max). Each item is scored from 0 to 3 0 = No sign, normal
- = weak or transient sign
- = moderate or only present half the time
- = strong or almost permanent sign
Measured: Hour 72
percentage of analgesic treatments
Comparison of Analgesic consumption between the 2 groups
Measured: Day 10
Blood loss
Comparison of Blood loss in ml between the 2 groups
Measured: Day 1
number of residual lesions assessed on TDM scanner images
Measured: 1 year
number of complications (duration of postoperative air leak greater than 5 days)
Measured: Day 10
number of complications (reoperation)
Measured: Day 10
number of complications (pneumothorax).
Measured: Day 10
Drainage duration
Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)
Measured: Day 10
Length of hospital stay
Comparison between the 2 groups of Length of hospital stay in days
Measured: Day 10
resection complexity classification
Development of a resection complexity classification similar to the PreText classification of hepatoblastoma
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study startSep 2020 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary MalformationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Hameury, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913416
- Sponsor's protocol ID
- 69HCL19_0030
- Acronym
- 3DLP
- Status last verified
- Mar 2020
- First submitted
- 10 Apr 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection
- ClinicalTrials.gov ID
- NCT03913416
- Acronym / sponsor ID
- 3DLP / 69HCL19_0030
- Conditions
- Pulmonary Malformation
- Keywords
- pulmonary malformation, 3D printed models, thoracotomy, thoracoscopy children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 12 Apr 2019 (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.
The National Rare Diseases plans, the ongoing MALFPULM PHRC and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. The resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to avoid exceptional tumors. Procedures are ideally performed around the age of 5-6 months to take advantage of the lung growth that continues during the first two years of life. The surgical strategies depend of the malformation size, the tumor risk and surgeon choice: conservative surgery with removal of part of the lobe may be preferred over complete resection of the concerned lobe.
If possible, thoracoscopic resection is carried out. The open thoracotomy is more painful and leads to complications such as thoracic deformities, larger scars, blood loss. However, in infants the thoracoscopic work space is small, lung exclusion is challenging and the anatomy (normal or malformative) is difficult to understand in space. The rate of thoracoscopy without conversion to thoracotomy ranges from 98% in one American center with a more radical approach , to 48% in a national cohort. Pulmonary exclusion failure, complexity and size of malformations and intra-operative complications are factors of conversion to thoracotomy . These factors can lead surgeons to perform thoracotomy without attempting thoracoscopy.
3D printing is a thriving research field for its educational or therapeutic potential optimization of management, prosthesis, and organ replacement. 3D printing is particularly adapted to pediatrics, which suffers from the rarity of its pathologies and a large spectrum of size and morphology prohibiting the mass production of models. 3D printing models of complex pulmonary pathologies will allowed for a better anesthetic and surgical approach. The modeling of bronchial, vascular and even parenchymatous anatomy permits a better understanding of the anatomical particularities of each patient. This, in turn, avoids the intra-operative conversions to thoracotomy with a direct benefit for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D | Experimental | Device: 3D printed modelSurgery with surgeon trained using a 3D printed model of the pulmonary malformation. |
| Control group | Other | Other: Control groupConventional surgery without training using a 3D printed model of the pulmonary malformation. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients aged from 1 day to 24 months.
- Patients with pulmonary malformation eligible for surgery
- Parents agreement for surgical treatment
- Parents able to sign an informed consent form
- Patient benefiting from a social insurance system or a similar system
Key exclusion criteria (5 listed)
- Emergency surgeries (less than 15 days between scanner and surgery)
- Obvious extrapulmonary sequestration on tomographic scanning images
- Patients with other major malformation additionally to pulmonary malformation
- Parents unable to understand the purpose of the trial
- Patient already participating to another clinical trial that might jeopardize the current trial
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 printed modelBefore surgery, the surgeon will have a 3D printed model of the pulmonary malformation as well as the lung, the rib cage and the tracheal trunk based on the initial scanner images. He will then be able to train and plan the surgical strategy, as well as to discuss the pulmonary exclusion with the anesthetist. | Device | 3D |
| Control groupThe control group is composed of patients operated with standard surgery | Other | Control group |
Primary outcome
proportion of intent to treat under thoracoscopy vs thoracotomy procedures
Time frame: Day 1
Comparisonbetween the 2 groups.
18 secondary outcomes
conversion rate from thoracoscopy over thoracoscopy attempted.
Time frame: Day 1
Proportion of effective pulmonary exclusion of the operated lung.
Time frame: Day 1
Proportion of variation between preoperative and effective strategy
Time frame: Day 1
induction time
Time frame: Day 1
Evaluation of pain using EVENDOL scale
Time frame: Hour 12
Evaluation of pain using EVENDOL scale
Time frame: Hour 24
Evaluation of pain using EVENDOL scale
Time frame: Hour 36
Evaluation of pain using EVENDOL scale
Time frame: Hour 48
Evaluation of pain using EVENDOL scale
Time frame: Hour 72
percentage of analgesic treatments
Time frame: Day 10
Blood loss
Time frame: Day 1
number of residual lesions assessed on TDM scanner images
Time frame: 1 year
number of complications (duration of postoperative air leak greater than 5 days)
Time frame: Day 10
number of complications (reoperation)
Time frame: Day 10
number of complications (pneumothorax).
Time frame: Day 10
Drainage duration
Time frame: Day 10
Length of hospital stay
Time frame: Day 10
resection complexity classification
Time frame: Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Frederic Hameury, MD principal investigator
Hospices Civils de Lyon
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 printed model in people with Pulmonary Malformation, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 18 Mar 2020. 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 France. 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 Frederic Hameury, MD (4 27 85 57 89 ext. +33, julien.berthiller@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of intent to treat under thoracoscopy vs thoracotomy procedures (time frame: Day 1). 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 18 Mar 2020.