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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Achieving Defined Grades of Tumor Devascularization
Tidsramme: 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%).
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24 hours post-embolization
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, nervevev
- Neoplasmer i nervesystemet
- Neoplasmer, vaskulært vev
- Meningeale neoplasmer
- Neoplasmer i sentralnervesystemet
- Hemangioma, kapillær
- Hemangioma
- Meningioma
- Neoplasmer i hjernen
- Hemangioblastom
Andre studie-ID-numre
- Embolization of Brain Tumors
Legemiddel- og utstyrsinformasjon, studiedokumenter
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