Clinical Value of Fine Needle Aspiration Cytology and Core Needle Biopsy in Head and Neck Pathology - A Nationwide Survey in Germany.

BACKGROUND/AIM: Fine-needle aspiration cytology (FNA) and core needle biopsy (CNB) of the thyroid gland, salivary glands, and lymph nodes are considered simple and rapid methods for minimally invasive tissue collection. We performed a postal survey to analyse the diagnostic value and complication rate of FNA and CNB in Germany. PATIENTS AND METHODS: A questionnaire comprising 11 questions was sent to all 161 German ENT departments in September 2015. RESULTS: The response rate was 45%. In 33 of the 73 responding clinics neither FNA nor CNB were carried out. Of the 26 clinics that provided detailed reasons, the majority (n=18) cited a lack of expertise among the collaborating pathologists. Overall, FNA was used more often, regardless of the anatomical region investigated. The study was based on a total of 36,684 FNAs and 9,624 CNBs. The rate of estimated meaningful and correct findings was 63% (10%-90%) for FNA, and 83% (50%-100%) for CNB. In eight cases (<0.001%) a potential tumor cell spread was reported. CONCLUSION: This is the first nationwide survey in Germany to investigate the utility of FNA and CNB across different localizations in the head and neck region. This study revealed comparable results to the literature regarding the diagnostic value of FNA and CNB. Cell spreading was only observed in individual cases. The appraisal of needle biopsies in the head and neck area seems to be rather inhomogeneous in Germany.

Basal Cell Carcinoma of the Head and Neck-A Retrospective Single-Centre Comparison of the Recurrence Rate after R0 or R1 Resection.

The treatment guidelines for basal cell carcinoma (BCC) postulate complete surgical excision using microscopically controlled resection (MOHS) as the gold standard. The need to obtain a small safety margin in the complex anatomical area of the head and neck is very challenging due to the individual characteristics (localization, histology, and size) of tumors and the fact that the postoperative loss of quality of life depends on the surgical defect size. The R1 status is histopathologically defined when the safety margin is less than 1 mm even if there are no tumor cells actually infiltrating the resection margin. Therefore, some studies have already favored a watch-and-wait-strategy in R1 situations. We aimed to evaluate the outcome and recurrence rate of resected BCCs of the head and neck, especially in a histologically proven R1 situation. The outcomes of all resected BCCs observed during a 5-year period (January 2009-December 2013) in a tertiary care center were analyzed. Our standard operating procedure was microscopically controlled surgical excision with reresections until an R0 situation was achieved. In selected patients, an R1 status has been accepted after at least two resections. From the included 191 BCCs, the R1 status was accepted as the final result in 46 (24.1%) cases which had surgically clear margins and were closely followed-up. From 54 patients in the R0 and 40 patients in the R1 group who completed the follow-up (2.4 ± 0.4 years), we observed 0 and 2 local recurrences, respectively (p = 0.19). In cases where frequent follow-up can be secured and the surgical area is delicate, a surgical closure at R1 status can be justified as the recurrence rate is not significantly higher compared with R0.

UV-C Light-Based Surface Disinfection: Analysis of Its Virucidal Efficacy Using a Bacteriophage Model.

Background: The reprocessing of medical devices has become more complex due to increasing hygiene requirements. Previous studies showed satisfactory bactericidal disinfection effects of UV-C light in rigid and flexible endoscopes. Especially in the context of the current COVID-19 pandemic, virucidal properties are of high importance. In the present study, the virucidal efficacy of UV-C light surface disinfection was analyzed. Methods: MS-2 bacteriophages were applied to the test samples and irradiated by UV-C light using the UV Smart D25 device; unirradiated test samples were used as controls. A dilution series of the samples was mixed with 1 × 108 Escherichia coli and assayed. Results: 8.6 × 1012 pfu could be harvested from the unprocessed test samples. In the control group without UV-C exposure, a remaining contamination of 1.2 × 1012 pfu was detected, resulting in a procedural baseline reduction rate with a LOG10 reduction factor of 0.72. The LOG10 reduction factor was found to be 3.0 after 25 s of UV-C light exposure. After 50 and 75 s of UV-C radiation LOG10 reduction factors 4.2 and 5.9, respectively, were found, with all reductions being statistically significantly different to baseline. Conclusions: The tested UV system seems to provide a significant virucidal effect after a relatively short irradiation time.

Clinical Impact of CYFRA 21-1 a Marker for Treatment Failure in Patients With Oropharyngeal Cancer Treated by Radio(chemo)therapy.

BACKGROUND: Primary radio(chemo)therapy [R(C)T] is a treatment option for advanced oropharyngeal squamous cell carcinoma (OSCC). Nevertheless, early diagnostics of treatment failure is problematic. Cytokeratin fragment 19 (CYFRA 21-1), an established marker in the management of pulmonary cancer, might be helpful here. Hence, in this study the impact of CYFRA 21-1 as an indicator for treatment failure and tumor recurrence (TR) in OSCC after R(C)T was analyzed. PATIENTS AND METHODS: The data of 77 patients with advanced OSCC and R(C)T were retrospectively examined. For determination of CYFRA 21-1 at the time of diagnosis and after R(C)T, an electrochemiluminescence immunoassay was used. Tumor residuals and tumor recurrence were pathologically verified after detection by radiological imaging and endoscopy. The mean follow-up was 44.4 months. RESULTS: After R(C)T, 48 (62%) patients showed locoregional control and 29 (38%) patients experienced locoregional failure. No statistical difference in the CYFRA 21-1 level between groups both before (p=0.75) and after R(C)T (p=0.85) was found. Nevertheless, in cases of TR in follow-up, the CYFRA 21-1 level was significantly higher (p≤0.01). The occurrence of TR was significantly associated with a CYFRA 21-1 elevation at this time (p≤0.01). However, CYFRA 21-1 failed to show a suitable discriminative ability for TR (area under the curve=0.57). CONCLUSION: In OSCC, CYFRA 21-1 does not seem to be a useful marker for locoregional failure after R(C)T. Nevertheless, a higher level immediately after R(C)T and in the further course of the disease may be associated with TR in individual patients.

Anti-IgE: A treatment option in allergic rhinitis?

BACKGROUND: Allergic rhinitis (AR) is the most common IgE-mediated allergic disease. Multiple clinical trials have demonstrated promising results on the AR treatment with biologics, in particular with the use of omalizumab - an anti-IgE antibody. Omalizumab has also been established in the routine management of allergic asthma and chronic idiopathic urticaria. However, currently there is no approved license for the use of biologics in AR in Germany. MATERIALS AND METHODS: A systematic literature review has been completed including randomized controlled trials, meta-analyses, and reviews on the treatment of AR with omalizumab. RESULTS: The systematic review demonstrates strong evidence supporting the use of omalizumab in the treatment of AR with regard to symptom control, safety profile, and management of comorbidities. CONCLUSION: Omalizumab is a good and safe option in the treatment of AR in terms of symptom control and the management of pre-existing comorbidities. Further clinical trials with other biologics in the management of AR are needed and are expected to follow soon.

UV light-based reprocessing of flexible endoscopes without working channel in Oto-Rhino-Laryngology: an effective method?

BACKGROUND: Reprocessing of flexible endoscopes (FEs) is often expensive, time consuming, and becomes increasingly complex, due to rising demands of hygiene. After beneficial results in reprocessing of rigid endoscopes using Impelux™ UV-C light technology, we tested the same method for reprocessing of FEs without working channel. MATERIALS AND METHODS: Testing was performed on FEs without working channel after routine clinical use (transnasal flexible endoscopy). Disinfection consisted of mechanical precleaning and 60 s exposure to Impelux™ UV-C light technology. Bacterial contamination was tested on 50 FEs before and after disinfection. Further 50 FEs regarding protein residuals. The absolute effectiveness of the D60 was tested on 50 test bodies (RAMS) with a standardized contamination of 107 colony-forming units (CFU) of Enterococcus faecium. RESULTS: The FEs were contaminated with a high average value of 916.7 CFU (± 1057 CFU) after clinical usage. After reprocessing, an average contamination of 2.8 CFU (± 1.6) on 14% (n = 7) of the FEs was detected consisting of non-pathogenic species, the remaining FE were sterile. After reprocessing, all FEs were protein-free (< 1 µg). The artificially contaminated test bodies showed no remaining bacterial contamination after disinfection, resulting in an average absolute germ reduction of about 107 CFU. CONCLUSION: Impelux™ UV-C light technology efficiently reduces bacterial contamination of FEs and might be useful in daily practice.

UV light-based decontamination: an effective and fast way for disinfection of endoscopes in otorhinolaryngology?

BACKGROUND: Reprocessing of endoscopes becomes increasingly complex, due to rising demands of hygiene. Established methods are often expensive/time-consuming. Recent studies suggest beneficial aspects of disinfection by UV light. In this study we analyzed the efficiency of UV light disinfection of rigid otorhinolaryngological endoscopes. MATERIALS AND METHODS: After mechanical pre-cleaning, the endoscopes were decontaminated for 25 s in the D25 using Impelux™ UV C light technology (UV Smart B.V., Delft, The Netherlands). First, the surface contact samples were taken from 50 used endoscopes to evaluate the bacterial load. Additionally, surface contact samples were taken from further 50 used endoscopes after reprocessing with the D25. Another 50 endoscopes were tested on protein residuals. Furthermore, the absolute effectiveness of the D25 was tested on 50 test bodies (RAMS) with a standardized contamination of 107 colony-forming units (CFU) of Enterococcus faecium. RESULTS: The used endoscopes showed a high bacterial contamination with an average value of 66.908 (± 239.215) CFU. After reprocessing, only a minimal contamination on 10% (n = 5) of the endoscopes with a mean value of 0.12 CFU (± 0.39) was found, resulting in a log-5 reduction in a clinical environment. The documented bacteria were components of the normal skin flora. All tested endoscopes were practically protein-free (< 1 µg). Furthermore, the average absolute germ reduction of the D25 was about 106 CFU on the tested RAMS. CONCLUSION: The D25 UV light system seems to be an effective device for the reprocessing of rigid ORL endoscopes, and therefore, might be suitable for the usage in clinical practice on site.

Clinical relevance of CYFRA 21-1 as a tumour marker in patients with oropharyngeal squamous cell carcinoma.

BACKGROUND: The role of Cytokeratin fraction 21-1 (CYFRA 21-1) as a tumour marker for head and neck cancer is still a matter of research. The aim of the present study was to evaluate the clinical impact of CYFRA 21-1 for patients with oropharyngeal squamous cell carcinoma (OSCC). PATIENTS AND METHODS: Data of 180 patients with an initial diagnosis of OSCC of any stage between 2003 and 2017 were retrospectively analysed regarding the association between pretherapeutic CYFRA 21-1 levels, clinical characteristics, overall and disease-free survival. Additionally, the potential of CYFRA 21-1 for the detection of recurrent disease in the follow-up was evaluated. The cut-off value was set at 3.3 ng/ml. The median follow-up time was 2.85 years. RESULTS: A significant correlation of the CYFRA 21-1 concentration at the time of diagnosis and the N-stage was detected (p = 0.01). Patients with CYFRA 21-1 levels > 3.3 ng/ml at first diagnosis showed a significantly shorter overall survival. In the case of disease-progression, a significant increase of CYFRA 21-1 value was found compared to post-therapeutic CYFRA 21-1 levels (9.1 ng/ml versus 5.1 ng/ml; p < 0.01). CYFRA 21-1 level after treatment showed only a low sensitivity of 32% and a specificity of 78% for tumour recurrence. CONCLUSION: CYFRA 21-1 correlates with the tumour stage and, therefore, the survival of OSCC patients. Posttreatment CYFRA21-1 seems not to be a suitable predictor of tumour recurrence in the further course of the disease. However, a sudden increase of CYFRA 21-1 during follow-up may indicate a tumour recurrence in the individual patient.

CYFRA 21-1: a suitable tumor marker in patients with head and neck cutaneous squamous cell carcinoma?

PURPOSE: The clinical significance of cytokeratin fraction 21-1 (CYFRA 21-1) for patients with head and neck cutaneous squamous cell carcinoma (CSCC) is unknown. Thus, the aim of the study was to evaluate the clinical value of CYFRA 21-1 in the context of treatment and follow-up for these patients. METHODS: The clinical, histological and laboratory data of a total of 55 patients with the first diagnosis of head and neck cutaneous squamous cell carcinoma (T1-T4, N0-N2b, M0-1) between 2003 and 2017 were retrospectively analyzed. In 25 cases, the primary tumor could be treated successfully without residual or recurrent disease in the further course. The average follow-up period was 2.3 years. In all patients, pretherapeutic determination of CYFRA 21-1 was performed using the ECLIA test kit. The cut-off value was set at 3.3 ng/ml. RESULTS: In 18 patients (32.7%), regional recurrence was found in the course of treatment. Distant metastases could be observed in two patients (3.6%). In these cases, no significant increase of CYFRA 21-1 blood concentration was detected at the time of recurrence/metastasis. At the time of the first diagnosis, the mean value of CYFRA 21-1 blood concentration was 2.4 ng/ml; and in cases of regional recurrence or distant metastases, the initial mean CYFRA 21-1 concentration was 2.0 ng/ml. There was no statistically significant relationship between CYFRA 21-1 blood concentration and analyzed tumor characteristics. CONCLUSIONS: According to current knowledge, the tumor marker CYFRA 21-1 is not clinically significant for treatment and follow-up of patients with head and neck CSCC.