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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Malformation
• Intervention / Treatment: Device: 3D printed model; Other: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederic Hameury, MD; Phone Number: +33 4 27 85 57 89; Email: julien.berthiller@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Hopital Femme Mere Enfant
    • Contact: Frederic Hameury, MD; Phone Number: +33 4 27 85 57 89

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D; Surgery with surgeon trained using a 3D printed model of the pulmonary malformation.	Device: 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.
OTHER: Control group; Conventional surgery without training using a 3D printed model of the pulmonary malformation.	Other: Control group; The control group is composed of patients operated with standard surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of intent to treat under thoracoscopy vs thoracotomy procedures	Comparisonbetween the 2 groups.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion rate from thoracoscopy over thoracoscopy attempted.	Comparison between the 2 groups.	Day 1
Proportion of effective pulmonary exclusion of the operated lung.		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)	Day 1
induction time	Comparison of induction time in minutes between the 2 strategies	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; = weak or transient sign; = moderate or only present half the time; = strong or almost permanent sign	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; = weak or transient sign; = moderate or only present half the time; = strong or almost permanent sign	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; = weak or transient sign; = moderate or only present half the time; = strong or almost permanent sign	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; = weak or transient sign; = moderate or only present half the time; = strong or almost permanent sign	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; = weak or transient sign; = moderate or only present half the time; = strong or almost permanent sign	Hour 72
percentage of analgesic treatments	Comparison of Analgesic consumption between the 2 groups	Day 10
Blood loss	Comparison of Blood loss in ml between the 2 groups	Day 1
number of residual lesions assessed on TDM scanner images		1 year
number of complications (duration of postoperative air leak greater than 5 days)		Day 10
number of complications (reoperation)		Day 10
number of complications (pneumothorax).		Day 10
Drainage duration	Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)	Day 10
Length of hospital stay	Comparison between the 2 groups of Length of hospital stay in days	Day 10
resection complexity classification	Development of a resection complexity classification similar to the PreText classification of hepatoblastoma	Day 10

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Frederic Hameury, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: thoracotomy; pulmonary malformation; 3D printed models; thoracoscopy children
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 69HCL19_0030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No