Clinical trial NCT06319664: Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas
Official title: Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas: a Single Center Report of 179 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skull Base Meningioma
Keywords: clinical outcomes
petroclival meningioma
skull base approach
meningioma classification
operative technique
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 179
Sex: ALL
Minimum age (years): 15
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. This study enrolled 28 males and 151 females with a male to female ratio of 1:5.4 and average age of 49.9±10.2 years (range 15-73 years). A total of 16 cases (8.9%) had been treated in other hospitals preoperatively with 12 cases of prior operations and 4 cases of prior gamma knife radiosurgery (GKS).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 1. combined with serious chronic diseases leading to inoperable therapy; 2. the partient refused to recevie surgical therapy; 3. combined with other cancers.

Primary outcomes:
measure: QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Qing Liu, MD
role: STUDY_DIRECTOR
References:
citation: Research must do no harm: new guidance addresses all studies relating to people. Nature. 2022 Jun;606(7914):434. doi: 10.1038/d41586-022-01607-0. No abstract available.