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

NCT03913416 | Unknown

• 1 other identifier: 69HCL19_0030
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Keywords

pulmonary malformation; 3D printed models; thoracotomy; thoracoscopy children

Outcome Measures

Primary Outcomes (1)

• proportion of intent to treat under thoracoscopy vs thoracotomy procedures

  Comparisonbetween the 2 groups.

  Day 1

Secondary Outcomes (18)

• conversion rate from thoracoscopy over thoracoscopy attempted.

  Day 1

• Proportion of effective pulmonary exclusion of the operated lung.

  Day 1

• Proportion of variation between preoperative and effective strategy

  Day 1

• induction time

  Day 1

• Evaluation of pain using EVENDOL scale

  Hour 12

Study Arms (2)

3D

EXPERIMENTAL

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

Device: 3D printed model

Control group

OTHER

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

Other: Control group

Interventions

3D printed model 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.

3D

Control group OTHER

The control group is composed of patients operated with standard surgery

Control group

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Femme Mere Enfant

Bron, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Frederic Hameury, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Hameury, MD

CONTACT

4 27 85 57 89; julien.berthiller@chu-lyon.fr

Julien BERTHILLER

CONTACT

4 72 11 80 67; julien.berthiller@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

FR (1)