Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319664
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-01-17
Brief Title:
Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas a Single Center Report of 179 Cases
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 210 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 005 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 individuals for the publication of any potentially identiļ¬able 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 30 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 III subtotal resection STR Simpson Grades IIIIV with 90-99 excision of the lesion and partial resection PR Simpson IIIIV 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 RP meant lesion regrowth in situ in GTR cases or residual lesion regrowth with the increase of the maximal diameter more than 3 mm in STRPR cases Those who experienced tumor RP 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 patients 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 210 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 005 was considered statistically significant
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 30 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 III subtotal resection STR Simpson Grades IIIIV with 90-99 excision of the lesion and partial resection PR Simpson IIIIV 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 RP meant lesion regrowth in situ in GTR cases or residual lesion regrowth with the increase of the maximal diameter more than 3 mm in STRPR cases Those who experienced tumor RP 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 patients 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 210 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 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None