Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06798532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AKA-NBL
Brief Summary:
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: