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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Malformation
• Interventions: Device: 3D printed model; Other: Control group

• Registration Number: NCT03913416
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18
• Study Start: 2020-09
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 178

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D	3D printed model	Surgery with surgeon trained using a 3D printed model of the pulmonary malformation.
Control group	Control group	Conventional surgery without training using a 3D printed model of the pulmonary malformation.

Primary Outcome Measures

Name	Time	Method
proportion of intent to treat under thoracoscopy vs thoracotomy procedures	Day 1	Comparisonbetween the 2 groups.

Secondary Outcome Measures

Name	Time	Method
percentage of analgesic treatments	Day 10	Comparison of Analgesic consumption between the 2 groups
Length of hospital stay	Day 10	Comparison between the 2 groups of Length of hospital stay in days
resection complexity classification	Day 10	Development of a resection complexity classification similar to the PreText classification of hepatoblastoma
conversion rate from thoracoscopy over thoracoscopy attempted.	Day 1	Comparison between the 2 groups.
Proportion of effective pulmonary exclusion of the operated lung.	Day 1
Proportion of variation between preoperative and effective strategy	Day 1	Variation of strategy in terms of type of resection (lobar, sub-lobar or segmental resection)
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	Day 10	Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)
induction time	Day 1	Comparison of induction time in minutes between the 2 strategies
Blood loss	Day 1	Comparison of Blood loss in ml between the 2 groups
number of residual lesions assessed on TDM scanner images	1 year
Evaluation of pain using EVENDOL scale	Hour 72	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; 1. = weak or transient sign; 2. = moderate or only present half the time; 3. = strong or almost permanent sign

Trial Locations

Locations (1)

Hopital Femme Mere Enfant; 🇫🇷 Bron, France