Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection

Study Overview
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Brief Summary
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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.

Official Title
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Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection

Conditions
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Pulmonary Malformation

Intervention / Treatment
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* Device: 3D printed model
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D<br>Surgery with surgeon trained using a 3D printed model of the pulmonary malformation. | Device: 3D printed model<br>* 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.<br>|
| Other: Control group<br>Conventional surgery without training using a 3D printed model of the pulmonary malformation. | Other: Control group<br>* The control group is composed of patients operated with standard surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of intent to treat under thoracoscopy vs thoracotomy procedures | Comparisonbetween the 2 groups. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion rate from thoracoscopy over thoracoscopy attempted. | Comparison between the 2 groups. | Day 1 | 
| Proportion of effective pulmonary exclusion of the operated lung. |  | 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) | Day 1 | 
| induction time | Comparison of induction time in minutes between the 2 strategies | 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 | 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 | 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 | 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 | 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 | Hour 72 | 
| percentage of analgesic treatments | Comparison of Analgesic consumption between the 2 groups | Day 10 | 
| Blood loss | Comparison of Blood loss in ml between the 2 groups | Day 1 | 
| number of residual lesions assessed on TDM scanner images |  | 1 year | 
| number of complications (duration of postoperative air leak greater than 5 days) |  | Day 10 | 
| number of complications (reoperation) |  | Day 10 | 
| number of complications (pneumothorax). |  | Day 10 | 
| Drainage duration | Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml) | Day 10 | 
| Length of hospital stay | Comparison between the 2 groups of Length of hospital stay in days | Day 10 | 
| resection complexity classification | Development of a resection complexity classification similar to the PreText classification of hepatoblastoma | Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary malformation, 3D printed models, thoracotomy, thoracoscopy children