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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03913416
Acronym
3DLP
Enrollment
178
Registered
2019-04-12
Start date
2020-09-30
Completion date
2024-09-30
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Malformation

Keywords

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

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.

Interventions

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.

OTHERControl group

The control group is composed of patients operated with standard surgery

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
proportion of intent to treat under thoracoscopy vs thoracotomy proceduresDay 1Comparisonbetween the 2 groups.

Secondary

MeasureTime frameDescription
conversion rate from thoracoscopy over thoracoscopy attempted.Day 1Comparison between the 2 groups.
Proportion of effective pulmonary exclusion of the operated lung.Day 1
Proportion of variation between preoperative and effective strategyDay 1Variation of strategy in terms of type of resection (lobar, sub-lobar or segmental resection)
induction timeDay 1Comparison of induction time in minutes between the 2 strategies
Evaluation of pain using EVENDOL scaleHour 12Comparison 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
percentage of analgesic treatmentsDay 10Comparison of Analgesic consumption between the 2 groups
Blood lossDay 1Comparison of Blood loss in ml between the 2 groups
number of residual lesions assessed on TDM scanner images1 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 durationDay 10Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)
Length of hospital stayDay 10Comparison between the 2 groups of Length of hospital stay in days
resection complexity classificationDay 10Development of a resection complexity classification similar to the PreText classification of hepatoblastoma

Countries

France

Contacts

Primary ContactFrederic Hameury, MD
julien.berthiller@chu-lyon.fr4 27 85 57 89
Backup ContactJulien BERTHILLER
julien.berthiller@chu-lyon.fr4 72 11 80 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026