A new study protocol for in-vivo assessment of tumor diagnosis and microscopic tumor infiltration at the resection cavity in central nervous system tumors by a new miniature confocal endomicroscope (CONVIVO system).

BACKGROUND: Confocal laser technology has been recently suggested as a promising method to obtain near real-time intraoperative histological data. We recently demonstrated the accuracy of a newly designed confocal endomiscroscope (CONVIVO) in offering an intraoperative diagnosis during high-grade gliomas (HGGs) removal in an ex vivo study. With this work we aim to perform a standardized, prospective and blinded-to-histological section study for evaluating the potentiality of CONVIVO in offering in-vivo data regarding histological diagnosis and presence of tumor at margins during resection of central nervous system (CNS) tumors. METHODS: This prospective, observational, standardized, blinded-to-histological section, clinical trial was approved by the institutional review board in Carlo Besta Neurologic Institute IRCCS Foundation in Milan and is expected to last 24 months. 75 patients will be included, with at least 53 of them being HGGs based on the statistical sample size calculation. Main objectives will be the assessing of the concordance of tumor diagnoses between CONVIVO images and frozen section at the center of all tumor subtypes and the evaluation of the accuracy of CONVIVO in the identification of tumor tissue at the margins, compared to standard histology. For this purpose, "virtual biopsies" and physical biopsies will be performed directly on patient tumor tissue and surrounding brain parenchima during tumor resection, comparing the results of CONVIVO analysis and frozen and histological sections. RESULTS: Despite promising preliminary data on ex vivo usefulness of CLE machines are emerging in literature, still few studies are available when looking at in vivo potentiality of CONVIVO. At this regard, this study will be the first work where a standardized, prospective, and blinded-to-histological section CONVIVO analysis will be performed in an in-vivo setting in neuro-oncological surgery. CONCLUSIONS: We hypothesize that this new technique may have a role in offering data regarding presence of tumor tissue, eventually giving an intraoperative diagnosis in neuro-oncological surgery, rendering more fluid the decision-making process in the operating room. Furthermore, the result of this study will provide a solid base for further expanding the clinical applications of confocal machines in neurosurgery.

Outcome prediction in brain tumor surgery: a literature review on the influence of nonmedical factors.

The purpose of the present study was to review the existing data on preoperative nonmedical factors that are predictive of outcome in brain tumor surgery. Our hypothesis was that also the individual characteristics (e.g., emotional state, cognitive status, social relationships) could influence the postoperative course in addition to clinical factors usually investigated in brain tumor surgery. PubMed, Embase, and Scopus were searched from 2008 to 2018 using terms relating to brain tumors, craniotomy, and predictors. All types of outcome were considered: clinical, cognitive, and psychological. Out of 6.288 records identified, 16 articles were selected for analysis and a qualitative synthesis of the prognostic factors was performed. The following nonmedical factors were found to be predictive of surgical outcomes: socio-demographic (age, marital status, type of insurance, gender, socio-economic status, type of hospital), cognitive (preoperative language and cognitive deficits, performance at TMT-B test), and psychological (preoperative depressive symptoms, personality traits, autonomy for daily activities, altered mental status). This review showed that nonmedical predictors of outcome exist in brain tumor surgery. Consequently, individual characteristics (e.g., emotional state, cognitive status, social relationships) can influence the postoperative course in addition to clinical factors.

Disability in Italian neurosurgical patients: validity of the 12-item World Health Organization Disability Assessment Schedule.

The aim of the study was to assess factor structure, internal consistency and validity of the Italian version of the World Health Organization Disability Assessment Schedule 12-item version (WHODAS-12) in patients scheduled for neurosurgical procedures for brain tumours, cerebrovascular or spinal diseases. Disability was assessed with the WHODAS-12, quality of life with the eight-item European Health Interview Survey-Quality of Life, well-being with the Psychological General Well-Being Index-Short and general health with the Karnofsky Performance Status (KPS) scales. Factor analysis was used to confirm WHODAS-12 one-factor structure; root mean square error of approximation (RMSEA) and χ2/d.f. ratio were used to test the model fit. Internal consistency was assessed with Cronbach's α coefficient, item-total correlation and interitem correlation; convergent validity was assessed with Pearson's coefficient and discriminative validity was assessed with the t-test, dividing patients between those with KPS greater than 90 and KPS of 90 or less. The one-factor structure was confirmed (RMSEA=0.079; χ2/d.f.=2.16) and internal consistency was adequate. Correlations between the three outcome measures were significant, negative and moderate; the t-test showed disability scores to be statistically significantly higher in patients with KPS of 90 or less. Our results confirm factor structure and validity of WHODAS-12 in Italian neurosurgical inpatients; we therefore support its use in neurosurgery departments.