Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) 2. Basithoracic location between T8 and L1. 3. With or without intraspinal component. 4. Treated in a pediatric surgery department in France. 5. Between 2005 and 2024. 6. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06798532
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marianna MD CornetSabine MD, PhD Sarnacki
Principal Investigator Affiliation Assistance Publique - Hôpitaux de ParisAssistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tumor, Solid, Neuroblastic Tumors, Neuroblastoma
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Other: - Collection of data from the patient's medical file.

Collection of data from the patient's medical file.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU d'Amiens, Amiens, France

Status

Address

CHU d'Amiens

Amiens, , 80000

Site Contact

Xavier MD Delforge

delforge.xavier@chu-amiens.fr

0033322087560

CHU de Besançon, Besançon, France

Status

Address

CHU de Besançon

Besançon, , 25000

Site Contact

Yann MD Chaussy

ychaussy@chu-besancon.fr

0033381219403

CHU de Bordeaux, Bordeaux, France

Status

Address

CHU de Bordeaux

Bordeaux, , 33000

Site Contact

Frederic MD Lavrand

frederic.lavrand@chu-bordeaux.fr

0033557821948

CHU de Brest, Brest, France

Status

Address

CHU de Brest

Brest, , 29200

Site Contact

Philine MD, PhD de Vries

philine.devries@chu-brest.fr

0033298223926

CHU de Lyon, Bron, France

Status

Address

CHU de Lyon

Bron, , 69677

Site Contact

Frédéric MD Hameury

frederic.hameury@chu-lyon.fr

0033427869217

CHU de Caen, Caen, France

Status

Address

CHU de Caen

Caen, , 14000

Site Contact

Jean-Baptiste MD Marret

marret-jb@chru-caen.fr

0033231064489

CHU de Dijon, Dijon, France

Status

Address

CHU de Dijon

Dijon, , 21079

Site Contact

Emmanuel MD, PhD Sapin

emmanuel.sapin@chu-dijon.fr

0033380293415

CHU de Grenoble, Grenoble, France

Status

Address

CHU de Grenoble

Grenoble, , 38000

Site Contact

Christian MD, PhD Piolat

cpiolat@chu-grenoble.fr

0033476765900

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

Status

Address

Hôpital Bicêtre

Le Kremlin-Bicêtre, , 94270

Site Contact

Florent MD, PhD Guérin

florent.guerin@aphp.fr

0033145213191

CHU de Lille, Lille, France

Status

Address

CHU de Lille

Lille, , 59000

Site Contact

Dyuti MD Sharma

dyuti.sharma@chru-lille.fr

0033320444343

CHU de Limoges, Limoges, France

Status

Address

CHU de Limoges

Limoges, , 87000

Site Contact

Quentin MD Ballouhey

quentin.ballouhey@chu-limoges.fr

0033555058684

CHU de Marseille, Marseille, France

Status

Address

CHU de Marseille

Marseille, , 13005

Site Contact

Anne MD Dariel

anne.dariel@ap-hm.fr

0033491386682

CHU de Montpellier, Montpellier, France

Status

Address

CHU de Montpellier

Montpellier, , 34090

Site Contact

Nicolas MD, PhD Kalfa

nicolaskalfa@gmail.com

0033467338784

CHU de Nancy, Nancy, France

Status

Address

CHU de Nancy

Nancy, , 54100

Site Contact

Ludovic MD Mansuy

lu.mansuy@chru-nancy.fr

0033383598542

CHU Nantes, Nantes, France

Status

Address

CHU Nantes

Nantes, , 44000

Site Contact

Marc-David MD, PhD Leclair

marcdavid.leclair@chu-nantes.fr

0033240083585

CHU Nice, Nice, France

Status

Address

CHU Nice

Nice, , 06200

Site Contact

Jean-François MD Lecompte

lecompte.j@lenval.com

0033492030316

Hôpital Trousseau, Paris, France

Status

Address

Hôpital Trousseau

Paris, , 75012

Site Contact

Sabine MD, PhD Irtan

sabine.irtan@aphp.fr

0033144736302

Hôpital Necker enfants malades, Paris, France

Status

Address

Hôpital Necker enfants malades

Paris, , 75015

Site Contact

Marianna MD Cornet

marianna.cornet@aphp.fr

0033679699489

Hôpital Robert Debré, Paris, France

Status

Address

Hôpital Robert Debré

Paris, , 75019

Site Contact

Pascale MD Chomette

pascale.philippe-chomette@aphp.fr

0033186468216

CHU de Poitiers, Poitiers, France

Status

Address

CHU de Poitiers

Poitiers, , 86000

Site Contact

Aurelien MD, PhD Binet

aurelien.binet@univ-poitiers.fr

0033549444444

CHU de Reims, Reims, France

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Address

CHU de Reims

Reims, , 51100

Site Contact

Antoine MD Liné

aline@chu-reims.fr

0033326787578

CHU de Rennes, Rennes, France

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Address

CHU de Rennes

Rennes, , 35203 CEDEX 2

Site Contact

Alexis MD, PhD Arnaud

alexis.arnaud@chu-rennes.fr

0033299265930

CHU de Rouen, Rouen, France

Status

Address

CHU de Rouen

Rouen, , 76000

Site Contact

Agnès MD, PhD Liard-Zmuda

agnes.liard-zmuda@chu-rouen.fr

0033232888990

CHU de La Réunion, Saint-denis, France

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Address

CHU de La Réunion

Saint-denis, , 97405

Site Contact

Jean-Luc MD Michel

jean-luc.michel@chu-reunion.fr

00262262905490

CHU de Strasbourg, Strasbourg, France

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Address

CHU de Strasbourg

Strasbourg, , 671091

Site Contact

Sarah MD Jannier

sarah.jannier@chru-strasbourg.fr

0033388128097

CHU de Toulouse, Toulouse, France

Status

Address

CHU de Toulouse

Toulouse, , 31059 cedex 9

Site Contact

Olivier MD, PhD Abbo

abbo.o@chu-toulouse.fr

0033534558516

CHU de Tours, Tours, France

Status

Address

CHU de Tours

Tours, , 37000

Site Contact

Hubert MD, PhD Lardy

hubert.lardy@univ-tours.fr

0033247473820

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