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

NCT ID: NCT03913416

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2024-09-30

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.

Conditions

Pulmonary Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D

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

Group Type: EXPERIMENTAL

3D printed model

Intervention Type: DEVICE

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 group

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

Group Type: OTHER

Control group

Intervention Type: OTHER

The control group is composed of patients operated with standard surgery

Interventions

3D printed model

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.

Intervention Type: DEVICE

Control group

The control group is composed of patients operated with standard surgery

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Hameury, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hopital Femme Mere Enfant

Bron, , France

Countries

France

Central Contacts

Frederic Hameury, MD

Role: CONTACT

julien.berthiller@chu-lyon.fr

4 27 85 57 89 ext. +33

Julien BERTHILLER

Role: CONTACT

julien.berthiller@chu-lyon.fr

4 72 11 80 67 ext. +33

Facility Contacts

Frederic Hameury, MD

Role: primary

4 27 85 57 89 ext. +33

Other Identifiers

69HCL19_0030

Identifier Type: -

Identifier Source: org_study_id