Clinical trial NCT03913416: Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection
Official title: Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Malformation
Keywords: pulmonary malformation
3D printed models
thoracotomy
thoracoscopy children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 178
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: proportion of intent to treat under thoracoscopy vs thoracotomy procedures
timeFrame: Day 1
Secondary outcomes:
measure: conversion rate from thoracoscopy over thoracoscopy attempted.
timeFrame: Day 1
measure: Proportion of effective pulmonary exclusion of the operated lung.
timeFrame: Day 1
measure: Proportion of variation between preoperative and effective strategy
timeFrame: Day 1
measure: induction time
timeFrame: Day 1
measure: Evaluation of pain using EVENDOL scale
timeFrame: Hour 12
measure: Evaluation of pain using EVENDOL scale
timeFrame: Hour 24
measure: Evaluation of pain using EVENDOL scale
timeFrame: Hour 36
measure: Evaluation of pain using EVENDOL scale
timeFrame: Hour 48
measure: Evaluation of pain using EVENDOL scale
timeFrame: Hour 72
measure: percentage of analgesic treatments
timeFrame: Day 10
measure: Blood loss
timeFrame: Day 1
measure: number of residual lesions assessed on TDM scanner images
timeFrame: 1 year
measure: number of complications (duration of postoperative air leak greater than 5 days)
timeFrame: Day 10
measure: number of complications (reoperation)
timeFrame: Day 10
measure: number of complications (pneumothorax).
timeFrame: Day 10
measure: Drainage duration
timeFrame: Day 10
measure: Length of hospital stay
timeFrame: Day 10
measure: resection complexity classification
timeFrame: Day 10
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mere Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Frederic Hameury, MD
role: PRINCIPAL_INVESTIGATOR
References: