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

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ClinicalTrials.gov Identifier: NCT03913416
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Malformation Device: 3D printed model Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

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.

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




Primary Outcome Measures :
  1. proportion of intent to treat under thoracoscopy vs thoracotomy procedures [ Time Frame: Day 1 ]
    Comparisonbetween the 2 groups.


Secondary Outcome Measures :
  1. conversion rate from thoracoscopy over thoracoscopy attempted. [ Time Frame: Day 1 ]
    Comparison between the 2 groups.

  2. Proportion of effective pulmonary exclusion of the operated lung. [ Time Frame: Day 1 ]
  3. Proportion of variation between preoperative and effective strategy [ Time Frame: Day 1 ]
    Variation of strategy in terms of type of resection (lobar, sub-lobar or segmental resection)

  4. induction time [ Time Frame: Day 1 ]
    Comparison of induction time in minutes between the 2 strategies

  5. Evaluation of pain using EVENDOL scale [ Time Frame: Hour 12 ]

    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

  6. Evaluation of pain using EVENDOL scale [ Time Frame: Hour 24 ]

    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

  7. Evaluation of pain using EVENDOL scale [ Time Frame: Hour 36 ]

    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

  8. Evaluation of pain using EVENDOL scale [ Time Frame: Hour 48 ]

    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

  9. Evaluation of pain using EVENDOL scale [ Time Frame: 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

  10. percentage of analgesic treatments [ Time Frame: Day 10 ]
    Comparison of Analgesic consumption between the 2 groups

  11. Blood loss [ Time Frame: Day 1 ]
    Comparison of Blood loss in ml between the 2 groups

  12. number of residual lesions assessed on TDM scanner images [ Time Frame: 1 year ]
  13. number of complications (duration of postoperative air leak greater than 5 days) [ Time Frame: Day 10 ]
  14. number of complications (reoperation) [ Time Frame: Day 10 ]
  15. number of complications (pneumothorax). [ Time Frame: Day 10 ]
  16. Drainage duration [ Time Frame: Day 10 ]
    Comparison between the 2 groups of drainage duration in days (drain removal when loss lower than 50ml)

  17. Length of hospital stay [ Time Frame: Day 10 ]
    Comparison between the 2 groups of Length of hospital stay in days

  18. resection complexity classification [ Time Frame: Day 10 ]
    Development of a resection complexity classification similar to the PreText classification of hepatoblastoma



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913416


Contacts
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Contact: Frederic Hameury, MD 4 27 85 57 89 ext +33 julien.berthiller@chu-lyon.fr
Contact: Julien BERTHILLER 4 72 11 80 67 ext +33 julien.berthiller@chu-lyon.fr

Locations
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France
Hopital Femme Mere Enfant Not yet recruiting
Bron, France
Contact: Frederic Hameury, MD    4 27 85 57 89 ext +33      
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Frederic Hameury, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03913416     History of Changes
Other Study ID Numbers: 69HCL19_0030
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
pulmonary malformation
3D printed models
thoracotomy
thoracoscopy children
Additional relevant MeSH terms:
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Congenital Abnormalities