Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06319664 |
| Other study ID # |
sjnkzzj |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2021 |
| Est. completion date |
September 10, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Xiangya Hospital of Central South University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 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 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.
