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临床试验/NCT06319664
NCT06319664已完成不适用

Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas: a Single Center Report of 179 Cases

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2021年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
179
试验地点
1
主要终点
QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score

研究概览

简要总结

Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.

详细描述

  1. Study Design and Ethics Approval In this institutional study, 179 cases of PCM were retrospectively collected and analyzed from January 2011 to December 2020 in our neurosurgical department, Xiangya Hospital, Central South University. The studies involving human participants were reviewed and approved by the Ethics Committee of Xiangya Hospital, Central South University (approval no. 202103227) in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments. Patients provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.
  2. Evaluative Criteria Clinical characteristics with manifestation, neurological function status, neuroimaging and surgical records, and follow-up data were reviewed and evaluated. The preoperative, postoperative and follow-up QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. The preoperative radiological data were obtained from routine examination of brain 3.0 T magnetic resonance imaging (MRI) with T1-weighted, T2-weighted and T1-contrast-enhanced sequences, computed tomography angiography (CTA) and skull base high-resolution computed tomography (HRCT) scans to evaluate tumor size, origin of dural attachment, growth pattern, involved circumjacent range, brainstem displacement, peritumoral edema, encasement of vital neurovascular structure and hydrocephalus to further identify tumor classification and treatment strategy. All of cases were re-examined with contrast MRI to identify the EOR within 72 hours post-operative. The EOR was divided into three levels of gross total resection (GTR) (Simpson Grades I/II), subtotal resection (STR) (Simpson Grades III/IV, with 90-99% excision of the lesion) and partial resection (PR) (Simpson III/IV, with below 90% excision of the lesion), depending on the intraoperative identification and postoperative MRI.

A combination of outpatient, telephone and Internet connections were used for follow-up. Follow-up data, including clinical and radiographic information, was collected 3 and 6 months after the surgical procedure and then every 1 or 2 years, in most cases via clinic visits. Questionnaires and phone calls were also carried out. The tumor recurrence or progress (R/P) meant lesion regrowth in situ in GTR cases or residual lesion regrowth with the increase of the maximal diameter more than 3 mm in STR/PR cases. Those who experienced tumor R/P were recommended for additional treatment. The latest follow-up deadline is March 1, 2021. 3. PCM Classification On the basis of the variation of PCM pathological alteration in anatomy and with the accumulating experience and incisive comprehension to PCM, we modified and improved our previous tumor classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). 4. Skull Base Approach Choice The skull base approach choice was fundamentally followed by the modified classification. At the same time, the patient's age, request and physical condition cannot be ignored. In this study, the retrosigmoid approach (RSA), subtemporal transtentorial transpetrosal approach (STTA), extended pterional transtentorial approach (EPTA), pretemporal trancavernous anterior transpetrosal approach (PTCA) and presigmoid combined supra-infratentorial approach (PCA) were applied as the main surgical approaches. Moreover, the RSA included basic retrosigmoid approach (BRSA), retrosigmoid trantentorial approach (RTTA) and retrosigmoid intradural suprameatal approach (RISA). Intraoperative neurophysiological monitoring containing somatosensory evoked potentials (SSEP), motor evoked potentials (MEP) and brainstem auditory evoked potentials (BAEP) were essentially and routinely implemented. 5. Statistical Analysis Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P < 0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 73 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed as the PCM from the MRI follwoed the definition of PCM.

排除标准

  • combined with serious chronic diseases leading to inoperable therapy;
  • the partient refused to recevie surgical therapy;
  • combined with other cancers.

结局指标

主要结局

QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score

时间窗: an average of 1 year

QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score by two neurosurgeons, independently, on admission, discharge, and follow-up, correspondingly. Follow-up KPS score was collected through study completion, an average of 1 year, in most cases via clinic visits.

次要结局

未报告次要终点

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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