Preoperative Embolization for Highly Vascular Brain Tumors
Preoperative Embolization for Highly Vascularised Intracranial Tumors
Highly vascular brain tumors, including meningiomas, hemangioblastomas, and certain metastases, have a rich blood supply that can lead to substantial blood loss and technical difficulties during surgical removal. Preoperative endovascular embolization is an adjunctive, catheter-based procedure used to block the feeding blood vessels of the tumor before surgery, aiming to reduce intraoperative bleeding and facilitate safer tumor resection.
The primary purpose of this study is to evaluate the technical feasibility, safety, and effectiveness of preoperative endovascular embolization in patients with highly vascular intracranial tumors.
Participants enrolled in this prospective study will undergo:
- Pre-procedural neurological and diagnostic cross-sectional imaging (contrast-enhanced MRI or CT angiography).
- Diagnostic digital subtraction angiography (DSA) to map tumor-feeding arteries, followed by super-selective catheterization to deliver embolic materials (polyvinyl alcohol particles, Onyx, or microcoils).
- Microsurgical tumor resection within 24 to 72 hours following the embolization procedure.
Researchers will assess the degree of tumor devascularization achieved, the volume of intraoperative blood loss, blood transfusion requirements, total surgical duration, extent of tumor resection, and the occurrence of any procedure-related complications.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Diagnosis of a hypervascular brain tumor (e.g., meningioma, hemangioblastoma, or hypervascular metastasis) confirmed by contrast-enhanced MRI or CT
- Scheduled for preoperative endovascular embolization followed by microsurgical resection
Exclusion Criteria:
- Severe, uncorrected coagulopathy
- Severe allergy to iodinated contrast media
- Severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²)
- Absence of safe arterial access
- Absence of identifiable tumor-feeding vessels suitable for selective microcatheterization
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Preoperative Embolization and Surgical Resection
Participants undergo pre-procedural neurological and imaging assessment, followed by diagnostic digital subtraction angiography (DSA) to identify tumor-feeding vessels.
Super-selective microcatheterization is performed to deliver embolic agents (polyvinyl alcohol [PVA] particles, Onyx, or microcoils) for tumor devascularization.
Post-embolization devascularization is evaluated by repeat DSA/CT, followed by microsurgical tumor resection within 24 to 72 hours.
|
Diagnostic cerebral digital subtraction angiography (DSA) is performed to identify tumor-feeding arteries and exclude dangerous anastomoses.
Super-selective microcatheterization is then conducted to deliver embolic materials (polyvinyl alcohol [PVA] particles, Onyx, or microcoils) directly into the tumor vasculature.
Tumor devascularization is quantified via post-procedural DSA/CT (<50%, 50-80%, or >80%).
Following endovascular devascularization, patients undergo microsurgical tumor resection within 24 to 72 hours.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Achieving Defined Grades of Tumor Devascularization
Tidsram: 24 hours post-embolization
|
Tumor devascularization is determined by comparing post-embolization digital subtraction angiography (DSA) or CT angiography against baseline diagnostic imaging.
Participants are categorized into three predefined grades based on devascularization of tumor vascular blush: poor (<50%), moderate (50% to 80%), or good/complete (>80%).
|
24 hours post-embolization
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer, nervvävnad
- Neoplasmer i nervsystemet
- Neoplasmer, vaskulär vävnad
- Meningeala neoplasmer
- Neoplasmer i centrala nervsystemet
- Hemangiom, kapillär
- Hemangiom
- Meningiom
- Neoplasmer i hjärnan
- Hemangioblastom
Andra studie-ID-nummer
- Embolization of Brain Tumors
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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