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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554173
Other study ID # 20-HPNCL-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 24, 2020
Est. completion date December 30, 2021

Study information

Verified date August 2021
Source Fondation Lenval
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is essential. Minimal invasive surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied. Thoracotomy has specific long terms post operative complications. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube ans length of stay. Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study. The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.


Description:

Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is usually essential in there treatment. Minimal invasive surgery with video assisted thoracic surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied. Thoracotomy has specific long terms post operative complications including scoliosis, shoulder elevation, winged scapula and asymmetric nipples. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube and length of stay. Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study. The authors concluded that thoracoscopy could be used for all paravertebral locations without IDRF except the IDRF of T9-T12 location and the presence of an intraspinal component but should be avoided for perivascular locations due to tight adherences of the tumour to the vessels and hence the risk of important bleeding. The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: All children operated for neurogenic thoracic tumors with minimal invasive surgery Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
surgical resection neurogenic tumors
Patient who was treated for a thoracic neurogenic tumor by minimally invasive surgery

Locations

Country Name City State
France Hôpitaux Pédiatrique de Nice CHU Lenval Nice

Sponsors (1)

Lead Sponsor Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reason of failure of thoracoscopy counting of number of bleeding and surgical difficulties for a period of 30 days after surgery at inclusion
Secondary Post operative complications duration of hospitalization at inclusion
Secondary Post operative complications number 2 Duration of chest tube at inclusion