- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06798532
Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors (AKA-NBL)
Neuroblastic tumors (NBTs) develop from neural crest cells that give rise to the sympathetic nervous system. They include neuroblastomas, ganglioneuroblastomas, and ganglioneuromas. They represent approximately 10% of solid tumors in children under 15 years of age. In 15 to 20% of cases, NBTs are located in the thoracic region. These paravertebral tumors have an extracanal component and some also have an intraspinal component (dumbbell tumors) that can cause spinal cord compression. Surgery for these tumors also exposes the patient to neurological complications. In the thorax, the basi-thoracic location (T9-T12) may be particularly at risk due to the presence of the artery of Adamkiewicz (AKA), which supplies blood to the spinal cord; damage to this artery can result in spinal cord ischemia. To avoid this scenario, some teams recommend performing spinal cord arteriography to identify AKA. However, many centers do not perform arteriography and do not report more postoperative complications.
Currently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT.
This study evaluates the practice in France of preoperative arteriography to identify the AKA among patients undergoing surgery for basi-thoracic neuroblastic tumors and analyzes the incidence of postoperative neurological complications in these patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neuroblastic tumors (NBTs) develop from neural crest cells that give rise to the sympathetic nervous system. They include neuroblastomas, ganglioneuroblastomas, and ganglioneuromas. They represent approximately 10% of solid tumors in children under 15 years of age. In 15 to 20% of cases, NBTs are located in the thoracic region. These paravertebral tumors have an extracanal component and some also have an intraspinal component (dumbbell tumors) that can cause spinal cord compression. Surgery for these tumors also exposes the patient to neurological complications. In the thorax, the basi-thoracic location (T9-T12) may be particularly at risk due to the presence of the artery of Adamkiewicz (AKA), which supplies blood to the spinal cord; damage to this artery can result in spinal cord ischemia. To avoid this scenario, some teams recommend performing spinal cord arteriography to identify AKA. However, many centers do not perform arteriography and do not report more postoperative complications.
Currently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT.
This study evaluates the practice in France of preoperative arteriography to identify the AKA among patients undergoing surgery for basi-thoracic neuroblastic tumors and analyzes the incidence of postoperative neurological complications in these patients.
It seems that in France, unlike other European sites, there is no systematic search for the artery of Adamkiewicz before surgery for neuroblastic tumors in most pediatric surgery departments. It does not seem that this is responsible for postoperative neurological complications but this assessment has never been performed.
The hypothesis of the study is that the neurological complications observed postoperatively are due to nerve root surgery or to spinal cord injury by direct trauma through the foramens, but not to spinal cord ischemia.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hélène Morel
- Phone Number: 0033171196346
- Email: helene.morel@aphp.fr
Study Contact Backup
- Name: Sabine MD, PhD Sarnacki
- Phone Number: 0033144494194
- Email: sabine.sarnacki@aphp.fr
Study Locations
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Amiens, France, 80000
- CHU d'AMIENS
-
Contact:
- Xavier MD Delforge
- Phone Number: 0033322087560
- Email: delforge.xavier@chu-amiens.fr
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Besançon, France, 25000
- CHU de Besancon
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Contact:
- Yann MD Chaussy
- Phone Number: 0033381219403
- Email: ychaussy@chu-besancon.fr
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Bordeaux, France, 33000
- CHU de Bordeaux
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Contact:
- Frederic MD Lavrand
- Phone Number: 0033557821948
- Email: frederic.lavrand@chu-bordeaux.fr
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Brest, France, 29200
- CHU de Brest
-
Contact:
- Philine MD, PhD de Vries
- Phone Number: 0033298223926
- Email: philine.devries@chu-brest.fr
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Bron, France, 69677
- CHU de Lyon
-
Contact:
- Frédéric MD Hameury
- Phone Number: 0033427869217
- Email: frederic.hameury@chu-lyon.fr
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Caen, France, 14000
- CHU de Caen
-
Contact:
- Jean-Baptiste MD Marret
- Phone Number: 0033231064489
- Email: marret-jb@chru-caen.fr
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Dijon, France, 21079
- Chu de Dijon
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Contact:
- Emmanuel MD, PhD Sapin
- Phone Number: 0033380293415
- Email: emmanuel.sapin@chu-dijon.fr
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Grenoble, France, 38000
- CHU de Grenoble
-
Contact:
- Christian MD, PhD Piolat
- Phone Number: 0033476765900
- Email: cpiolat@chu-grenoble.fr
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Le Kremlin-Bicêtre, France, 94270
- Hôpital Bicêtre
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Contact:
- Florent MD, PhD Guérin
- Phone Number: 0033145213191
- Email: florent.guerin@aphp.fr
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Lille, France, 59000
- CHU de LILLE
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Contact:
- Dyuti MD Sharma
- Phone Number: 0033320444343
- Email: dyuti.sharma@chru-lille.fr
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Limoges, France, 87000
- CHU de Limoges
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Contact:
- Quentin MD Ballouhey
- Phone Number: 0033555058684
- Email: quentin.ballouhey@chu-limoges.fr
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Marseille, France, 13005
- CHU de Marseille
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Contact:
- Anne MD Dariel
- Phone Number: 0033491386682
- Email: anne.dariel@ap-hm.fr
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Montpellier, France, 34090
- CHU de Montpellier
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Contact:
- Nicolas MD, PhD Kalfa
- Phone Number: 0033467338784
- Email: nicolaskalfa@gmail.com
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Nancy, France, 54100
- CHU de Nancy
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Contact:
- Ludovic MD Mansuy
- Phone Number: 0033383598542
- Email: lu.mansuy@chru-nancy.fr
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Nantes, France, 44000
- CHU Nantes
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Contact:
- Marc-David MD, PhD Leclair
- Phone Number: 0033240083585
- Email: marcdavid.leclair@chu-nantes.fr
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Nice, France, 06200
- CHU Nice
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Contact:
- Jean-François MD Lecompte
- Phone Number: 0033492030316
- Email: lecompte.j@lenval.com
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Paris, France, 75019
- Hôpital Robert Debré
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Contact:
- Pascale MD Chomette
- Phone Number: 0033186468216
- Email: pascale.philippe-chomette@aphp.fr
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Paris, France, 75015
- Hôpital Necker Enfants Malades
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Contact:
- Marianna MD Cornet
- Phone Number: 0033679699489
- Email: marianna.cornet@aphp.fr
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Paris, France, 75012
- Hôpital Trousseau
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Contact:
- Sabine MD, PhD Irtan
- Phone Number: 0033144736302
- Email: sabine.irtan@aphp.fr
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Poitiers, France, 86000
- Chu de Poitiers
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Contact:
- Aurelien MD, PhD Binet
- Phone Number: 0033549444444
- Email: aurelien.binet@univ-poitiers.fr
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Reims, France, 51100
- Chu de Reims
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Contact:
- Antoine MD Liné
- Phone Number: 0033326787578
- Email: aline@chu-reims.fr
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Rennes, France, 35203 CEDEX 2
- CHU de Rennes
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Contact:
- Alexis MD, PhD Arnaud
- Phone Number: 0033299265930
- Email: alexis.arnaud@chu-rennes.fr
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Rouen, France, 76000
- CHU de Rouen
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Contact:
- Agnès MD, PhD Liard-Zmuda
- Phone Number: 0033232888990
- Email: agnes.liard-zmuda@chu-rouen.fr
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Saint-Denis, France, 97405
- CHU de la réunion
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Contact:
- Jean-Luc MD Michel
- Phone Number: 00262262905490
- Email: jean-luc.michel@chu-reunion.fr
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Strasbourg, France, 671091
- CHU de Strasbourg
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Contact:
- Sarah MD Jannier
- Phone Number: 0033388128097
- Email: sarah.jannier@chru-strasbourg.fr
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Toulouse, France, 31059 cedex 9
- CHU de Toulouse
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Contact:
- Olivier MD, PhD Abbo
- Phone Number: 0033534558516
- Email: abbo.o@chu-toulouse.fr
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Tours, France, 37000
- CHU de Tours
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Contact:
- Hubert MD, PhD Lardy
- Phone Number: 0033247473820
- Email: hubert.lardy@univ-tours.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma, ganglioneuroma)
- Basithoracic location between T8 and L1
- With or without intraspinal component
- Treated in a pediatric surgery department in France
- Between 2005 and 2024
- Adult patients or holders of parental authority of minor patients informed and not opposed to the use of data for the study
Exclusion Criteria:
1. Post-operative follow-up of less than 6 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric patients
Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma) with basi-thoracic location between T8 and L1, with or without intraspinal component and treated in a pediatric surgery department in France between 2005 and 2024.
|
Collection of data from the patient's medical file.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of neurological complications secondary to spinal cord ischemia
Time Frame: 2005 to 2024
|
Assessment of postoperative neurological complications in patients undergoing surgery for basi-thoracic NBT, with or without preoperative spinal cord arteriography.
|
2005 to 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic characteristics of patients undergoing surgery for basithoracic neuroblastic tumor
Time Frame: 2005 to 2024
|
Describe the demographic characteristics of patients undergoing surgery for basithoracic neuroblastic tumor.
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2005 to 2024
|
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Outcome of patients undergoing surgery for basithoracic neuroblastic tumor
Time Frame: 2005 to 2024
|
Describe the overall survival and recurrence-free survival.
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2005 to 2024
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marianna MD Cornet, Assistance Publique - Hôpitaux de Paris
- Principal Investigator: Sabine MD, PhD Sarnacki, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Boglino C, Martins AG, Ciprandi G, Sousinha M, Inserra A. Spinal cord vascular injuries following surgery of advanced thoracic neuroblastoma: an unusual catastrophic complication. Med Pediatr Oncol. 1999 May;32(5):349-52. doi: 10.1002/(sici)1096-911x(199905)32:53.0.co;2-p.
- Nordin AB, Fallon SC, Jea A, Kim ES. The use of spinal angiography in the management of posterior mediastinal tumors: case series and review of the literature. J Pediatr Surg. 2013 Sep;48(9):1871-7. doi: 10.1016/j.jpedsurg.2013.04.029.
- Schmidt A, Hempel JM, Ellerkamp V, Warmann SW, Ernemann U, Fuchs J. The Relevance of Preoperative Identification of the Adamkiewicz Artery in Posterior Mediastinal Pediatric Tumors. Ann Surg Oncol. 2022 Jan;29(1):493-499. doi: 10.1245/s10434-021-10381-8. Epub 2021 Jul 31.
- Bosmia AN, Hogan E, Loukas M, Tubbs RS, Cohen-Gadol AA. Blood supply to the human spinal cord: part I. Anatomy and hemodynamics. Clin Anat. 2015 Jan;28(1):52-64. doi: 10.1002/ca.22281. Epub 2013 Jun 27.
- De Bernardi B, Gambini C, Haupt R, Granata C, Rizzo A, Conte M, Tonini GP, Bianchi M, Giuliano M, Luksch R, Prete A, Viscardi E, Garaventa A, Sementa AR, Bruzzi P, Angelini P. Retrospective study of childhood ganglioneuroma. J Clin Oncol. 2008 Apr 1;26(10):1710-6. doi: 10.1200/JCO.2006.08.8799.
- Furak J, Geczi T, Tiszlavicz L, Lazar G. Postoperative paraplegia after resection of a giant posterior mediastinal tumour. Importance of the blood supply in the upper spinal cord. Interact Cardiovasc Thorac Surg. 2011 May;12(5):855-6. doi: 10.1510/icvts.2010.257105. Epub 2011 Feb 8.
- Lindeire S, Hauser JM. Anatomy, Back, Artery of Adamkiewicz. 2025 Mar 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532971/
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive, Peripheral
- Neuroectodermal Tumors, Primitive
- Neoplasms
- Neuroblastoma
- Ganglioneuroblastoma
- Ganglioneuroma
Other Study ID Numbers
- APHP241337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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