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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018305', 'term': 'Ganglioneuroblastoma'}, {'id': 'D005729', 'term': 'Ganglioneuroma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of neurological complications secondary to spinal cord ischemia', 'timeFrame': '2005 to 2024', 'description': 'Assessment of postoperative neurological complications in patients undergoing surgery for basi-thoracic NBT, with or without preoperative spinal cord arteriography.'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics of patients undergoing surgery for basithoracic neuroblastic tumor', 'timeFrame': '2005 to 2024', 'description': 'Describe the demographic characteristics of patients undergoing surgery for basithoracic neuroblastic tumor.'}, {'measure': 'Outcome of patients undergoing surgery for basithoracic neuroblastic tumor', 'timeFrame': '2005 to 2024', 'description': 'Describe the overall survival and recurrence-free survival.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroblastic tumors', 'Neuroblastomas', 'Ganglioneuroblastomas', 'Ganglioneuromas', 'Adamkiewicz Artery', 'Pediatric surgery'], 'conditions': ['Tumor, Solid', 'Neuroblastic Tumors', 'Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '30422566', 'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '24074660', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34331163', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23813725', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18375900', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21303870', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10219336', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nCurrently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT.\n\nThis 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.', 'detailedDescription': '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.\n\nCurrently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT.\n\nThis 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.\n\nIt 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery for a neuroblastic tumor in a pediatric surgery department in France between 2005 and 2024 and meeting the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma, ganglioneuroma)\n2. Basithoracic location between T8 and L1\n3. With or without intraspinal component\n4. Treated in a pediatric surgery department in France\n5. Between 2005 and 2024\n6. Adult patients or holders of parental authority of minor patients informed and not opposed to the use of data for the study\n\nExclusion Criteria:\n\n1\\. Post-operative follow-up of less than 6 months'}, 'identificationModule': {'nctId': 'NCT06798532', 'acronym': 'AKA-NBL', 'briefTitle': 'Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors', 'orgStudyIdInfo': {'id': 'APHP241337'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients', 'description': '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.', 'interventionNames': ["Other: Collection of data from the patient's medical file."]}], 'interventions': [{'name': "Collection of data from the patient's medical file.", 'type': 'OTHER', 'description': "Collection of data from the patient's medical file.", 'armGroupLabels': ['Pediatric patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'contacts': [{'name': 'Xavier MD Delforge', 'role': 'CONTACT', 'email': 'delforge.xavier@chu-amiens.fr', 'phone': '0033322087560'}], 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Yann MD Chaussy', 'role': 'CONTACT', 'email': 'ychaussy@chu-besancon.fr', 'phone': '0033381219403'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Frederic MD Lavrand', 'role': 'CONTACT', 'email': 'frederic.lavrand@chu-bordeaux.fr', 'phone': '0033557821948'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Philine MD, PhD de Vries', 'role': 'CONTACT', 'email': 'philine.devries@chu-brest.fr', 'phone': '0033298223926'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'contacts': [{'name': 'Frédéric MD Hameury', 'role': 'CONTACT', 'email': 'frederic.hameury@chu-lyon.fr', 'phone': '0033427869217'}], 'facility': 'CHU de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste MD Marret', 'role': 'CONTACT', 'email': 'marret-jb@chru-caen.fr', 'phone': '0033231064489'}], 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Emmanuel MD, PhD Sapin', 'role': 'CONTACT', 'email': 'emmanuel.sapin@chu-dijon.fr', 'phone': '0033380293415'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'contacts': [{'name': 'Christian MD, PhD Piolat', 'role': 'CONTACT', 'email': 'cpiolat@chu-grenoble.fr', 'phone': '0033476765900'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'contacts': [{'name': 'Florent MD, PhD Guérin', 'role': 'CONTACT', 'email': 'florent.guerin@aphp.fr', 'phone': '0033145213191'}], 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Dyuti MD Sharma', 'role': 'CONTACT', 'email': 'dyuti.sharma@chru-lille.fr', 'phone': '0033320444343'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87000', 'city': 'Limoges', 'country': 'France', 'contacts': [{'name': 'Quentin MD Ballouhey', 'role': 'CONTACT', 'email': 'quentin.ballouhey@chu-limoges.fr', 'phone': '0033555058684'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Anne MD Dariel', 'role': 'CONTACT', 'email': 'anne.dariel@ap-hm.fr', 'phone': '0033491386682'}], 'facility': 'CHU de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Nicolas MD, PhD Kalfa', 'role': 'CONTACT', 'email': 'nicolaskalfa@gmail.com', 'phone': '0033467338784'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Ludovic MD Mansuy', 'role': 'CONTACT', 'email': 'lu.mansuy@chru-nancy.fr', 'phone': '0033383598542'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Marc-David MD, PhD Leclair', 'role': 'CONTACT', 'email': 'marcdavid.leclair@chu-nantes.fr', 'phone': '0033240083585'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Jean-François MD Lecompte', 'role': 'CONTACT', 'email': 'lecompte.j@lenval.com', 'phone': '0033492030316'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Sabine MD, PhD Irtan', 'role': 'CONTACT', 'email': 'sabine.irtan@aphp.fr', 'phone': '0033144736302'}], 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Marianna MD Cornet', 'role': 'CONTACT', 'email': 'marianna.cornet@aphp.fr', 'phone': '0033679699489'}], 'facility': 'Hôpital Necker enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Pascale MD Chomette', 'role': 'CONTACT', 'email': 'pascale.philippe-chomette@aphp.fr', 'phone': '0033186468216'}], 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Aurelien MD, PhD Binet', 'role': 'CONTACT', 'email': 'aurelien.binet@univ-poitiers.fr', 'phone': '0033549444444'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'contacts': [{'name': 'Antoine MD Liné', 'role': 'CONTACT', 'email': 'aline@chu-reims.fr', 'phone': '0033326787578'}], 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35203 CEDEX 2', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Alexis MD, PhD Arnaud', 'role': 'CONTACT', 'email': 'alexis.arnaud@chu-rennes.fr', 'phone': '0033299265930'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Agnès MD, PhD Liard-Zmuda', 'role': 'CONTACT', 'email': 'agnes.liard-zmuda@chu-rouen.fr', 'phone': '0033232888990'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '97405', 'city': 'Saint-Denis', 'country': 'France', 'contacts': [{'name': 'Jean-Luc MD Michel', 'role': 'CONTACT', 'email': 'jean-luc.michel@chu-reunion.fr', 'phone': '00262262905490'}], 'facility': 'CHU de La Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '671091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Sarah MD Jannier', 'role': 'CONTACT', 'email': 'sarah.jannier@chru-strasbourg.fr', 'phone': '0033388128097'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059 cedex 9', 'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Olivier MD, PhD Abbo', 'role': 'CONTACT', 'email': 'abbo.o@chu-toulouse.fr', 'phone': '0033534558516'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Hubert MD, PhD Lardy', 'role': 'CONTACT', 'email': 'hubert.lardy@univ-tours.fr', 'phone': '0033247473820'}], 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Sabine MD, PhD Sarnacki', 'role': 'CONTACT', 'email': 'sabine.sarnacki@aphp.fr', 'phone': '0033144494194'}, {'name': 'Hélène Morel', 'role': 'CONTACT', 'email': 'helene.morel@aphp.fr', 'phone': '0033171196346'}], 'overallOfficials': [{'name': 'Marianna MD Cornet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Sabine MD, PhD Sarnacki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}