DIUOP: An Appraisal of Minimal Invasive Surgery for Thoracic Neurogenic Tumour

Sponsor
Fondation Lenval (Other)
Overall Status
Completed
CT.gov ID
NCT04554173
Collaborator
(none)
30
1
20.2
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical resection neurogenic tumors

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
An Appraisal of Minimal Invasive Surgery for Thoracic Child Neurogenic Tumour. A Multicentric Study
Actual Study Start Date :
Apr 24, 2020
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
surgical resection neurogenic tumors

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

Outcome Measures

Primary Outcome Measures

  1. Reason of failure of thoracoscopy [at inclusion]

    counting of number of bleeding and surgical difficulties for a period of 30 days after surgery

Secondary Outcome Measures

  1. Post operative complications [at inclusion]

    duration of hospitalization

  2. Post operative complications number 2 [at inclusion]

    Duration of chest tube

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

All children operated for neurogenic thoracic tumors with minimal invasive surgery

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpitaux Pédiatrique de Nice CHU Lenval Nice France

Sponsors and Collaborators

  • Fondation Lenval

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Lenval
ClinicalTrials.gov Identifier:
NCT04554173
Other Study ID Numbers:
  • 20-HPNCL-01
First Posted:
Sep 18, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Lenval
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022