Neurogenic Thoracic TumorsDIUOPNCT04554173
An Appraisal of Minimal Invasive Surgery for Thoracic Neurogenic Tumour
An observational study of Neurogenic Thoracic Tumors, run by Fondation Lenval at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Neurogenic Thoracic Tumors
- What is being tested?
- surgical resection neurogenic tumors
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children operated for neurogenic thoracic tumors with minimal invasive surgery
Who may be able to join
- All children operated for neurogenic thoracic tumors with minimal invasive surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Appraisal of Minimal Invasive Surgery for Thoracic Child Neurogenic Tumour. A Multicentric Study
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.
Read more
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.
Read the 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.
- Conditions
- Neurogenic Thoracic Tumors
- Being tested
- surgical resection neurogenic tumors
- Keywords
- surgery, pediatric, surgical resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resection neurogenic tumorsProcedure or surgery
Patient who was treated for a thoracic neurogenic tumor by minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| surgical resection neurogenic tumors | Not described Receives: Procedure: surgical resection neurogenic tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason of failure of thoracoscopy
counting of number of bleeding and surgical difficulties for a period of 30 days after surgery
Measured: at inclusion
Secondary outcomes (2)
Post operative complications
duration of hospitalization
Measured: at inclusion
Post operative complications number 2
Duration of chest tube
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start24 Apr 2020
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Thoracic TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554173
- Sponsor's protocol ID
- 20-HPNCL-01
- Acronym
- DIUOP
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Appraisal of Minimal Invasive Surgery for Thoracic Child Neurogenic Tumour. A Multicentric Study
- ClinicalTrials.gov ID
- NCT04554173
- Acronym / sponsor ID
- DIUOP / 20-HPNCL-01
- Conditions
- Neurogenic Thoracic Tumors
- Keywords
- surgery, pediatric, surgical resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical resection neurogenic tumors | – | Procedure: surgical resection neurogenic tumors |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children operated for neurogenic thoracic tumors with minimal invasive surgery
Key inclusion criteria (1 listed)
- All children operated for neurogenic thoracic tumors with minimal invasive surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical resection neurogenic tumorsPatient who was treated for a thoracic neurogenic tumor by minimally invasive surgery | Procedure or surgery | surgical resection neurogenic tumors |
Primary outcome
Reason of failure of thoracoscopy
Time frame: at inclusion
counting of number of bleeding and surgical difficulties for a period of 30 days after surgery
2 secondary outcomes
Post operative complications
Time frame: at inclusion
Post operative complications number 2
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Thoracic Tumors, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reason of failure of thoracoscopy (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.