An interventional study of 3D printed model and Control group in Pulmonary Malformation, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 1 Day to 24 Months. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 178 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
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Exclusion Criteria:
Surgery with surgeon trained using a 3D printed model of the pulmonary malformation.
Device: 3D printed model
Conventional surgery without training using a 3D printed model of the pulmonary malformation.
Other: Control group
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.
The control group is composed of patients operated with standard surgery
proportion of intent to treat under thoracoscopy vs thoracotomy procedures
Comparisonbetween the 2 groups.
Time frame: Day 1
conversion rate from thoracoscopy over thoracoscopy attempted.
Comparison between the 2 groups.
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
Variation of strategy in terms of type of resection (lobar, sub-lobar or segmental resection)
Time frame: Day 1
induction time
Comparison of induction time in minutes between the 2 strategies
Time frame: 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 1. = weak or transient sign 2. = moderate or only present half the time 3. = strong or almost permanent sign
Time frame: 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 1. = weak or transient sign 2. = moderate or only present half the time 3. = strong or almost permanent sign
Time frame: 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 1. = weak or transient sign 2. = moderate or only present half the time 3. = strong or almost permanent sign
Time frame: 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 1. = weak or transient sign 2. = moderate or only present half the time 3. = strong or almost permanent sign
Time frame: 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 1. = weak or transient sign 2. = moderate or only present half the time 3. = strong or almost permanent sign
Time frame: Hour 72
percentage of analgesic treatments
Comparison of Analgesic consumption between the 2 groups
Time frame: Day 10
Blood loss
Comparison of Blood loss in ml between the 2 groups
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
Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)
Time frame: Day 10
Length of hospital stay
Comparison between the 2 groups of Length of hospital stay in days
Time frame: Day 10
resection complexity classification
Development of a resection complexity classification similar to the PreText classification of hepatoblastoma
Time frame: Day 10
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Hospices Civils de Lyon