Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06803251
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2024-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of the Vascular Surgeon in Oncologic Surgery of Abdominal and Pelvic Retroperitoneal Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012186', 'term': 'Retroperitoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of vascular issues during the procedure', 'timeFrame': 'From the first patient enrolled to the 70th patient, an average of 3 years', 'description': 'Numbers of major and minor vascular issues during retroperitoneal procedures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retroperitoneal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Retroperitoneal tumors (RPTs - retroperitoneal tumors) are neoplasms that originate from the soft tissues of the retroperitoneum and in their more invasive forms can involve the retroperitoneal organs and large abdominal and pelvic vascular structures. They are divided into benign tumors (20%), of which teratomas and tumors of neurogenic origin are the most frequent, and malignant tumors (80%), of which the most frequent are sarcomas (RPS - retroperitoneal sarcoma)1.\n\nThese are often large lesions, which can exceed 15 cm in diameter and which develop asymptomatically until the surrounding structures are involved. The initial symptoms are often represented by lumbar pain and abdominal distension which occur after multiple organ involvement.\n\nTo date, the treatment of choice is surgical excision of the mass with the aim of obtaining a clean resection margin R0 (macroscopically and microscopically free of disease) or R1 (with margin only macroscopically free of disease).\n\nThe most recent literature on this topic demonstrates how the treatment of RPS in specialized centers by a multidisciplinary team that works as a team and uses cutting-edge diagnostic and surgical techniques can improve the R0/R1 resection rate and overall survival. (OS)2.\n\nThe rate of intra- and post-operative surgical complications increases in direct proportion to the width of the excision; however, major complications are not associated with statistically significant differences in terms of OS, local recurrence (LR) and survival in the absence of distant metastases', 'detailedDescription': 'Very large abdominal and pelvic retroperitoneal masses frequently involve the retroperitoneal vascular structures.\n\nData from the literature show that after spinal surgery and orthopedic surgery, oncological surgery represents a specialist branch that frequently requires intraoperative vascular surgical assistance (6.7 - 9.6% of requests)5,6\n\n. In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during cleavage and isolation of the mass, ligation or complete reconstruction of the vascular segment involved and contributes to reducing intraoperative and postoperative complications.\n\nThe clinical relevance of the evaluation of the short- and long-term results of the study lies in the fact that the case study it is expected to obtain greatly exceeds the few already published. Knowledge of outcomes on a larger sample will help shed light on aspects such as the need for more or less extensive surgical resection and on the choice of revascularization technique.\n\nThe primary objective of the study is to evaluate the outcomes of musculoskeletal tumor removal procedures in relation to the type of vascular surgical care provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients belonging to the UU.OO. General Surgery, Urology and Gynecological Oncology of the IRCCS University Hospital of Bologna, with diagnosis of intra-abdominal or pelvic retroperitoneal mass with involvement of vascular structures and indication for surgical treatment of removal of the mass which requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with a retroperitoneal mass involving the abdominal and/or pelvic vascular structures and requiring surgical removal\n* Planned surgical treatment with intra-operative assistance from the vascular surgeon\n* Obtaining informed consent\n* Age 18 years\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06803251', 'acronym': 'IOVA-rpt', 'briefTitle': 'The Role of the Vascular Surgeon in Oncologic Surgery of Abdominal and Pelvic Retroperitoneal Masses', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Il Ruolo Del Chirurgo Vascolare Nella Chirurgia Oncologica Delle Masse Addominali E Pelviche Retroperitoneali', 'orgStudyIdInfo': {'id': 'IOVA-rpt'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mauro Prof Gargiulo, MD', 'role': 'CONTACT', 'email': 'mauro.gargiulo2@unibo.it', 'phone': '0512143288'}], 'facility': "IRCCS AOU di Bologna Policlinico di Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Mauro MG Gargiulo, MD', 'role': 'CONTACT', 'email': 'mauro.gargiulo2@unibo.it', 'phone': '0512143288', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Mauro Gargiulo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}