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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Pulmonary Malformation

Treatments: Device: 3D printed model; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03913416

69HCL19_0030

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 1 day to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

3D

Experimental group

Description:

Surgery with surgeon trained using a 3D printed model of the pulmonary malformation.

Treatment:

Device: 3D printed model

Control group

Other group

Description:

Conventional surgery without training using a 3D printed model of the pulmonary malformation.

Treatment:

Other: Control group