NCT06319664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

January 17, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

clinical outcomespetroclival meningiomaskull base approachmeningioma classificationoperative technique

Outcome Measures

Primary Outcomes (1)

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

    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.

    an average of 1 year

Study Arms (6)

Clivus type

The dural attachment originates from petroclival fissure, and the main portion of lesion is situated on middle-upper clivus, mainly grows toward the median line and even the heterolateral direction, could involve in the whole clivus region from dorsum sellae to foramen magnum.

Procedure: retrosigmoid approach (RSA)

Petroclival type

The dural attachment originates likewise from petroclival fissure, but primarily extends toward the homolateral dorsal petrosum region, and the main portion is center on middle-upper clivus and grows toward petrous apex region forward and cerebellopontine angle region backward, leading to the homolateral trigeminus being compressed outwards.

Procedure: retrosigmoid approach (RSA)

Petroclivosphenoidal type

The site of origin lies on petroclival region, while the main part of lesion is located in posterior cranial fossa and extends forward and upward along petroclival fissure, and could spread to posterior clinoid process, dorsum sellae and parasellar area with striding petrous ridge, or expanding into Meckel's cave (MC) and even reaching posterior wall of cavernous sinus (CS) through MC. Overall, the growth pattern direction is basically from posterior cranial fossa to middle cranial fossa and from the infratentorial to supratentorial compartment.

Procedure: retrosigmoid approach (RSA)Procedure: subtemporal transtentorial transpetrosal approach (STTA)

Sphenopetroclival Subtype I

Sphenopetroclival type (S-PC type): The site of origin saddles the petrous ridge and invades the CS and parasellar region widely. The growth pattern is different from the PC-S type, mainly from the middle cranial fossa to the posterior cranial fossa. This type is then further classified into two subtypes based on the relationship between CS and the lesion site of origin. Subtype I (S-PC I type): The lesion mainly originates from posterior part of CS and posterior clinoid process region, could invade and break though the CS wall, and the main part of lesion expands towards parasellar, middle cranial fossa, and petrous apex, even invades the dorsum sellae and posterior cranial fossa through tentorium. As a result, the CS wall is mostly rough, and the dural space between the lesion and the temporal lobe is not well-defined on MRI.

Procedure: extended pterional transtentorial approach (EPTA)Procedure: presigmoid combined supra-infratentorial approach (PCA)

Sphenopetroclival Subtype II

The dural attachment of lesion entirely originates within the CS leading to CS region expansile hyperplasia with the virtually intact sinus wall, and part of lesion could spread into the petrous apex and posterior cranial fossa through posterior sinus wall; the large partial lesions may also encroach on the lateral wall of the CS expansion towards the middle cranial fossa. The lateral sinus wall is relatively smooth and maintains the dural space between the lesion and the temporal lobe on MRI.

Procedure: pretemporal trancavernous anterior transpetrosal approach (PTCA)Procedure: presigmoid combined supra-infratentorial approach (PCA)

Central Skull Base type

The dural attachment originates from the petroclival fissure, but growth pattern is widespread invasion of central skull base region and structures bilaterally and the site of origin extensively involves in dorsum sellae, clivus and bilateral suprasellar, parasellar and CS areas even cerebellopontine angle region.

Procedure: inoperable

Interventions

The skull base approach choice was fundamentally followed by the modified classification.

Clivus typePetroclival typePetroclivosphenoidal type

The skull base approach choice was fundamentally followed by the modified classification.

Petroclivosphenoidal type

The skull base approach choice was fundamentally followed by the modified classification.

Sphenopetroclival Subtype I

The skull base approach choice was fundamentally followed by the modified classification.

Sphenopetroclival Subtype II

The skull base approach choice was fundamentally followed by the modified classification.

Sphenopetroclival Subtype ISphenopetroclival Subtype II
inoperablePROCEDURE

The skull base approach choice was fundamentally followed by the modified classification.

Central Skull Base type

Eligibility Criteria

Age15 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

Location

Related Publications (1)

  • 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.

Study Officials

  • Qing Liu, MD

    Xiangya Hospital of Central South University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

March 20, 2024

Study Start

May 27, 2021

Primary Completion

August 10, 2021

Study Completion

September 10, 2021

Last Updated

March 20, 2024

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

When the research data has been published.

Locations