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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Achieving Defined Grades of Tumor Devascularization
기간: 24 hours post-embolization
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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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Embolization of Brain Tumors
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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