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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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%).
|
24 hours post-embolization
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, nervevæv
- Neoplasmer i nervesystemet
- Neoplasmer, vaskulært væv
- Meningeale neoplasmer
- Neoplasmer i centralnervesystemet
- Hæmangiom, kapillær
- Hæmangiom
- Meningiom
- Neoplasmer i hjernen
- Hemangioblastom
Andre undersøgelses-id-numre
- Embolization of Brain Tumors
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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