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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
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 |
Trial Details
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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 |
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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. |
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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 |
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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 |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Not yet recruiting |
| Countries | France |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Tumor, Solid, Neuroblastic Tumors, Neuroblastoma |
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.
