Status quo after one year of COVID-19 pandemic in otolaryngological hospital-based departments and private practices in Germany.

PURPOSE: The COVID-19 pandemic has affected healthcare systems worldwide. Data on the impact on otolaryngological clinics and private practices is sparse. This study aimed to present data on healthcare worker (HCW) screening, status of HCW, pre-interventional testing, the use of personal protective equipment (PPE) and the economic impact of the pandemic. METHODS: Otolaryngological private practices and hospital-based departments were surveyed nationwide using an online questionnaire. Participating facilities were recruited via the German Society for Oto-Rhino-Laryngology and the German Association for Otolaryngologists in Bavaria. RESULTS: 365 private practices (2776 employees) and 65 hospitals (2333 employees) were included. Significantly more hospitals (68.7%) than practices (40.5%) performed pre-interventional testing in their outpatients (p < 0.00). Most inpatients were tested in practices and hospitals (100.0% and 95.0%; p = 0.08). HCW screening was performed in 73.7% of practices and in 77.3% of hospitals (p = 0.54). Significantly more HCW infections were reported in private practices (4.7%) than in hospital (3.6%; p = 0.03). The private or home environment was the most frequent source of infection among HCW in hospitals (44%) and practices (63%). The use of PPE increased over the course of the pandemic. The number of procedures and the revenue decreased in 2020. CONCLUSION: The rate of pre-interventional testing among outpatients in otolaryngological practices is low and HCW infections were found to be more frequent in practices than in hospitals. In addition, a high rate of infections in otolaryngological HCW seems to stem from the private or home environment.

Double-endoscope assisted endoscopic submucosal dissection for treating tumors in rectum and distal colon by expert endoscopists: a feasibility study.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) is an effective but challenging procedure. To facilitate ESD, several methods that apply traction are available; however, the optimal one remains to be established. The aim of this study was to evaluate the feasibility and safety of the double-endoscope assisted ESD (DEA-ESD) by improving traction to treat complex colorectal lesions. METHODS: Naïve or previously treated lesions in the rectum and sigmoid colon were included. A grasping forceps advanced through a small-caliber endoscope (GIF-XP190N, Olympus Medical Systems, Tokyo, Japan, 5.4 mm outer diameter) was used to apply traction to the mucosal flap. Lesions were deemed complex when they exceeded a total of nine points on the SMSA scoring system (size, morphology, site, and access) and recurrent when they were previously treated with endoscopic mucosal resection (EMR). Outcome measures included procedural success, total procedure time, complications, and recurrence rate at 3-month follow-up. RESULTS: Nine patients (mean age 62.3 ± 14.5 years) were included; five had rectal and four had tumors in the sigmoid colon. The median SMSA score was 14 (SMSA Level IV-complex polyp), while three patients were pre-treated with EMR. DEA-ESD was technically feasible in all cases. En bloc resection and R0 resection rates were 100%, respectively, with a mean procedure time of 128.4 ± 54.1 min. No immediate or delayed complications occurred. CONCLUSIONS: DEA-ESD is a feasible and safe method for treating complex or recurrent tumors in the rectum and distal colon.

[Bed capacity management in times of the COVID-19 pandemic : A simulation-based prognosis of normal and intensive care beds using the descriptive data of the University Hospital Augsburg]. / Bettenkapazitätssteuerung in Zeiten der COVID-19-Pandemie : Eine simulationsbasierte Prognose der Normal- und Intensivstationsbetten anhand der deskriptiven Daten des Universitätsklinikums Augsburg.

BACKGROUND: Following the regional outbreak in China, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread all over the world, presenting the healthcare systems with huge challenges worldwide. In Germany the coronavirus diseases 2019 (COVID-19) pandemic has resulted in a slowly growing demand for health care with a sudden occurrence of regional hotspots. This leads to an unpredictable situation for many hospitals, leaving the question of how many bed resources are needed to cope with the surge of COVID-19 patients. OBJECTIVE: In this study we created a simulation-based prognostic tool that provides the management of the University Hospital of Augsburg and the civil protection services with the necessary information to plan and guide the disaster response to the ongoing pandemic. Especially the number of beds needed on isolation wards and intensive care units (ICU) are the biggest concerns. The focus should lie not only on the confirmed cases as the patients with suspected COVID-19 are in need of the same resources. MATERIAL AND METHODS: For the input we used the latest information provided by governmental institutions about the spreading of the disease, with a special focus on the growth rate of the cumulative number of cases. Due to the dynamics of the current situation, these data can be highly variable. To minimize the influence of this variance, we designed distribution functions for the parameters growth rate, length of stay in hospital and the proportion of infected people who need to be hospitalized in our area of responsibility. Using this input, we started a Monte Carlo simulation with 10,000 runs to predict the range of the number of hospital beds needed within the coming days and compared it with the available resources. RESULTS: Since 2 February 2020 a total of 306 patients were treated with suspected or confirmed COVID-19 at this university hospital. Of these 84 needed treatment on the ICU. With the help of several simulation-based forecasts, the required ICU and normal bed capacity at Augsburg University Hospital and the Augsburg ambulance service in the period from 28 March 2020 to 8 June 2020 could be predicted with a high degree of reliability. Simulations that were run before the impact of the restrictions in daily life showed that we would have run out of ICU bed capacity within approximately 1 month. CONCLUSION: Our simulation-based prognosis of the health care capacities needed helps the management of the hospital and the civil protection service to make reasonable decisions and adapt the disaster response to the realistic needs. At the same time the forecasts create the possibility to plan the strategic response days and weeks in advance. The tool presented in this study is, as far as we know, the only one accounting not only for confirmed COVID-19 cases but also for suspected COVID-19 patients. Additionally, the few input parameters used are easy to access and can be easily adapted to other healthcare systems.

Endoscopic treatment of Zenker's diverticulum with the stag beetle knife (sb knife) - feasibility and follow-up.

BACKGROUND AND AIMS: Flexible endoscopic treatment of symptomatic Zenker's diverticulum (ZD) is an established treatment option. This study reports the first large cohort of ZD patients treated with the stag beetle knife (sb knife, a new scissor-like device) regarding feasibility, safety, and sustainability of mucomyotomy using this technique. METHODS: From August 2013 to January 2016, n = 52 patients (pts) were treated at Klinikum Augsburg, a tertiary referral center, with the sb knife junior or standard. For stability and safety, the septum is fixed with a soft overtube before intervention. Symptoms were analyzed before and at 1 and 6 months past intervention using an extensive questionnaire of dysphagia, odynophagia, regurgitation, chronic cough, state of health, and complications. RESULTS: The mean size of ZD was 3 cm (1-5 cm). Forty-seven out of 52 (90.4%) patients received one treatment session. The mean procedure time was 32 min (18-60 min). In 10 procedures (17%), a clip was placed at the bottom of the resection line. No major complications (e.g., perforation, mediastinitis) occurred. Five patients (9.6%) required a second treatment after a mean of 7 months (3-13) due to symptomatic recurrence. One patient was lost to further follow-up after one month with no or rare complaints. One patient had a third treatment (1.9%) without complications. During a mean follow-up of 16 months (2-31), the dysphagia score improved from 2 (1-4) prior of treatment to 1 (0-4), odynophagia, regurgitation, and chronic cough were no longer reported in the asymptomatic patients at all. CONCLUSIONS: Flexible endoscopic treatment of ZD with the sb knife and overtube is effective, safe, and has lasting effects with a relatively low recurrence rate.

[Improvement of cost allocation in gastroenterology by introduction of a novel service catalogue covering the complete spectrum of endoscopic procedures]. / Verbesserung der Kostenkalkulation in der Gastroenterologie durch Einführung eines neuen Leistungskatalogs für alle endoskopischen Prozeduren.

BACKGROUND: The German hospital reimbursement system (G-DRG) is incomplete for endoscopic interventions and fails to differentiate between complex and simple procedures. This is caused by outdated methods of personnel-cost allocation. METHODS: To establish an up-to-date service catalogue 50 hospitals made their anonymized expense-budget data available to the German-Society-of-Gastroenterology (DGVS). 2.499.900 patient-datasets (2011-2013) were used to classify operation-and-procedure codes (OPS) into procedure-tiers (e.g. colonoscopy with biopsy/colonoscopy with stent-insertion). An expert panel ranked these tiers according to complexity and assigned estimates of physician time. From June to November 2014 exact time tracking data for a total 38.288 individual procedures were collected in 119 hospitals to validate this service catalogue. RESULTS: In this three-step process a catalogue of 97 procedure-tiers was established that covers 99% of endoscopic interventions performed in German hospitals and assigned validated mean personnel-costs using gastroscopy as standard. Previously, diagnostic colonoscopy had a relative personnel-cost value of 1.13 (compared to gastroscopy 1.0) and rose to 2.16, whereas diagnostic ERCP increased from 1.7 to 3.62, more appropriately reflecting complexity. Complex procedures previously not catalogued were now included (e.g. gastric endoscopic submucosal dissection: 16.74). DISCUSSION: This novel service catalogue for GI-endoscopy almost completely covers all endoscopic procedures performed in German hospitals and assigns relative personnel-cost values based on actual physician time logs. It is to be included in the national coding recommendation and should replace all prior inventories for cost distribution. The catalogue will contribute to a more objective cost allocation and hospital reimbursement - at least until time tracking for endoscopy becomes mandatory.

Endoscopic resection: when is EMR/ESD sufficient?

Endoscopic treatment of malignant lesions in the gastrointestinal tract can be treated curatively if the risk for lymph node metastasis is lower than 1%. In the lower gi-tract (colon and rectum) the low risk criteria for this situation are well-defined (G1/G2, LO, invasion depth ≤1000µm). However, en-bloc R0-resection is also mandatory. Benign lesions such as lateral spreading tumors (granular-type) can be also treated with piecemeal EMR, however, recurrence rate is up to 30%. All other cases, regardless of size, such as non-granular type lesions or mixed type lesions should be treated with endoscopic submucosal dissection. The definitive histopathology of the resected specimen allows further decision (e.g., surgery if invasion depth of tumor is >1000µm).

[Chronic renal insufficiency with hypercalcemia in a 60-year-old patient]. / Chronische Niereninsuffizienz mit Hyperkalzämie bei einem 60-jährigen Patienten.

A 60-year-old man developed stomach pains and early morning vomiting as well as fatigue over the last few months. Severe hypercalcemia was found in combination with a significantly reduced renal function. Laboratory tests as well as histological findings from the kidneys led to the working diagnosis of sarcoidosis with renal and possible osseous manifestations. After 14 days of oral medication with steroids the symptoms were significantly improved and renal parameters normalized.

[Acute abdomen-Rare cause in an 80-year-old female patient under immunosuppressive treatment]. / Akutes Abdomen ­ seltene Ursache bei einer 80-jährigen Patientin unter immunsuppressiver Therapie.

An 80-year-old woman presented to the emergency department due to abdominal pain. She had a history of opportunistic pneumonia under the effects of immunosuppression after the diagnosis of autoimmune hepatitis. The imaging showed an omental cake formation and the suspicion of peritoneal carcinomatosis. The patient developed an acute abdomen during the hospital stay, followed by exploratory laparotomy. In the presence of extensive intra-abdominal abscess formation both surgically acquired material and blood culture revealed disseminated nocardiosis. The course was fatal due to fulminant septic shock.

Endoscopic submucosal dissection in large sessile lesions of the rectosigmoid: learning curve in a European center.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) in the colorectum is not currently a standard procedure. Few data are available from the Western world. The aim of the present study was to report on the first experiences and the learning curve of colorectal ESD in a European center. PATIENTS AND METHODS: A total of 82 rectosigmoid lesions were referred for ESD. Lesion characteristics, resection rates, procedure times, complications, and recurrences were recorded prospectively. Results were compared between three consecutive study periods in order to determine the learning curve. RESULTS: Lesions were located in the rectum (86.6 %) and the sigmoid colon (13.4 %). Median diameter was 45.5 mm. Lesions were of Paris type 0-Is with pit pattern type V (n = 8), 0-IIa (n = 33), 0-IIa + Is (n = 36), and 0-IIa + IIc (n = 5). The malignancy rate in these groups was 100 %, 0 %, 14 %, and 20 %, respectively. ESD was possible in 76 lesions (92.7 %). En bloc resection rate and R0 resection rate were 81.6 % and 69.7 %, respectively. Median procedure time was 176 minutes. Between the three consecutive study periods, en bloc resection rate increased (60.0 %, 88.0 %, 96.2 %), R0 resection rate increased (48.0 %, 76.0 %, 84.5 %; P < 0.001), and procedure time decreased (200, 193, 136 minutes; P = 0.027). The perforation and bleeding rates were 1.3 % and 7.9 %, respectively. Recurrence risk was 0 % after R0 en bloc resection and 41.7 % after piecemeal resection (P < 0.05). Median follow-up was 23.6 months. CONCLUSIONS: In the European setting, ESD in the distal colon is feasible with acceptable complication risks. Resection rates were not as high as those from Japanese studies; however, a clear learning curve could be shown. Colorectal ESD needs to be further evaluated, particularly in Europe where ESD experience is low.

[COVID-19 and endoscopy services]. / COVID-19 und Endoskopieeinheiten: Erfahrungen und Empfehlungen nach 2 Jahren Pandemie.

In 2020, the coronavirus pandemic initially led to a significant decrease in elective endoscopic examinations in Germany. The main reasons for this were the hard lockdown and the lack of personal protective equipment (PPE) and testing procedures. Since then, international recommendations from professional societies on infection control in endoscopy have been published. The extent to which these have been implemented in Germany is unclear: during the 2nd and 3rd waves in 2020/2021, most endoscopy units remained open and the level of adherence to international protection guidelines was high. A uniform "standard procedure" has not yet been published. The exact role and effectiveness of testing procedures to protect patients and staff during endoscopy was unknown, and reliable figures on staff and patient infections acquired/transmitted in endoscopy units in Germany were lacking. Thus, the most important finding of this work is the determined rate of coronavirus disease 2019 (COVID-19) in endoscopy facilities. The data show that the infection rate among staff in German clinics and practices in early 2021 averaged up to 5%; most of these were acquired in the private setting. Clinics with gastroenterological endoscopy units had significantly higher infection rates (10%) than, for example, dental and otolaryngology practices. This result indicates the need for continued PPE efforts. The most important factors for infection safety are fully vaccinated (or recovered) staff and patients, a decreasing prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the use of PPE and-although controversial-the consistent use of screening tests.

Predictive preoperative clinical score for patients with liver-only oligometastatic colorectal cancer.

BACKGROUND: Resection of liver metastases from colorectal cancer (CRC) in the oligometastatic stage improves survival and is a potentially curative treatment. Thus, predictive scores that reliably identify those patients who especially benefit from surgery are essential. PATIENTS AND METHODS: In this multicenter analysis, 512 patients had undergone surgery for liver metastases from CRC. We investigated distinct cancer-specific risk factors that are routinely available in clinical practice and developed a predictive preoperative score using a training cohort (TC), which was thereafter tested in a validation cohort (VC). RESULTS: Inflammatory response to the tumor, a right-sided primary tumor, multiple liver metastases, and node-positive primary tumor were significant adverse variables for overall survival (OS). Patients were stratified in five groups according to the cumulative score given by the presence of these risk factors. Median OS for patients without risk factors was 133.8 months [95% confidence interval (CI) 81.2-not reached (nr)] in the TC and was not reached in the VC. OS decreased significantly for each subsequent group with increasing number of risk factors. Median OS was significantly shorter (P < 0.0001) for patients presenting all four risk factors: 14.3 months (95% CI 10.5 months-nr) in the TC and 16.6 months (95% CI 14.6 months-nr) in the VC. CONCLUSIONS: Including easily obtainable variables, this preoperative score identifies oligometastatic CRC patients with prolonged survival rates that may be cured, and harbors potential to be implemented in daily clinical practice.

KRAS mutation in metastatic pancreatic ductal adenocarcinoma: results of a multicenter phase II study evaluating efficacy of cetuximab plus gemcitabine/oxaliplatin (GEMOXCET) in first-line therapy.

BACKGROUND: Genetic alterations within the epidermal growth factor receptor (EGFR) pathway, including KRAS mutations, have been demonstrated to be associated with response to EGFR inhibitors like cetuximab in colorectal cancers. Mutations in the KRAS gene have been found in 70-90% of pancreatic cancers. Unfortunately, the addition of cetuximab to chemotherapy did not increase response or survival in patients with advanced pancreatic cancer in phase II and phase III studies. The aim of this study was to evaluate the relationship between KRAS mutations and response or survival in patients with metastatic pancreatic cancer treated with cetuximab plus chemotherapy. METHODS: Within a multicenter phase II trial, 64 patients with metastatic pancreatic cancer were treated with cetuximab in combination with gemcitabine and oxaliplatin until disease progression. Analyses of the EGFR pathway, including KRAS mutations, could be performed in 25 patients. Analyses were carried out following microdissection of the tumor. RESULTS: Fourteen (56%) of the 25 patients examined harbored a point mutation in codon 12 of the KRAS gene. No differences between the groups were noted in median progression-free survival (104 days in KRAS wild-type patients vs. 118 days in patients with KRAS mutations). Overall survival was longer in wild-type patients compared to patients with KRAS mutations (263 vs. 162 days), but the difference did not reach statistical significance. A further analysis of our clinical phase II trial showed that the presence of a rash was significantly correlated with overall survival. CONCLUSIONS: KRAS mutation in codon 12 may be associated with reduced survival compared to KRAS wild type. The role of KRAS mutations for cetuximab therapy in pancreatic cancer warrants further investigation in larger trials to exclude an epiphenomenon. Furthermore, the development of a rash is indicative of clinical benefit.

Endoscopic submucosal dissection in gastric neoplasia - experience from a European center.

BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) is a promising technique for the resection of early gastric neoplasia. There are only a few data from the Western world to date. METHODS: Over a 7-year-period, 104 gastric lesions were treated with ESD in a European referral center, of which 91 were included in this study. A total of 66 lesions were early gastric cancer (EGC) and 25 were adenomas. Of the EGCs, 11 lesions (16.7 %) fulfilled the guideline criteria (EGC-GC) and 55 lesions (83.3 %) fulfilled the expanded resection criteria (EGC-EC) of the Japanese guidelines for the treatment of gastric cancer. RESULTS: ESD was technically possible in 85 lesions (93.4 %). In six lesions ESD was not possible due to non-lifting. En bloc resection rates for all lesions, ECGs-GC, ECGs-EC, and adenomas were 87.1 %, 100 %, 88.2 %, and 79.2 %, respectively. R0 en bloc resection rates were 74.1 %, 90 %, 68.6 %, and 79.2 %, respectively. Complications were: one perforation during piecemeal endoscopic mucosal resection of a lesion in which ESD was judged to be impossible (1.2 %); three clinically relevant bleedings (3.5 %); one gastric ischemia (1.2 %); and four strictures (4.7 %). No mortality was observed. There were five recurrences after piecemeal resection (50 %) compared with only one after en bloc resection (1.5 %; P < 0.05). The rate of recurrence for EGCs was 5.6 %, and this were seen exclusively after piecemeal resection. CONCLUSIONS: Our data show that ESD is a feasible technique in Europe even in patients with EGC according to the extended criteria. Resection rates are promising and complication rates are acceptable. Results are worse compared with large studies from Japan but still excellent regarding the learning curve of the method. ESD should be offered as the treatment of choice for early gastric neoplasia especially when en bloc resection cannot be performed with other resection techniques.

Cetuximab plus gemcitabine/oxaliplatin (GEMOXCET) in first-line metastatic pancreatic cancer: a multicentre phase II study.

Targeting the epidermal growth factor receptor pathway in pancreatic cancer seems to be an attractive therapeutic approach. This study assessed the efficacy of cetuximab plus the combination of gemcitabine/oxaliplatin in metastatic pancreatic cancer. Eligible subjects had histological or cytological diagnosis of metastatic pancreatic adenocarcinoma. The primary end point was response according to RECIST. Patients received cetuximab 400 mg m(-2) at first infusion followed by weekly 250 mg m(-2) combined with gemcitabine 1000 mg m(-2) as a 100 min infusion on day 1 and oxaliplatin 100 mg m(-2) as a 2-h infusion on day 2 every 2 weeks. Between January 2005 and August 2006, a total of 64 patients (22 women (34%), 42 men (66%); median age 64 years (range 31-78)) were enrolled at seven study centres. On October 2007, a total of 17 patients were alive. Sixty-two patients were evaluable for baseline and 61 for assessment of response to treatment in an intention-to-treat analysis. Six patients had an incomplete drug combination within the first cycle of the treatment plan (n=4 hypersensitivity reactions to the first cetuximab infusion, n=2 refused to continue therapy). Reported grade 3/4 toxicities (% of patients) were leukopaenia 15%, anaemia 8%, thrombocytopaenia 10%, diarrhoea 7%, nausea 18%, infection 18% and allergy 7%. Cetuximab-attributable skin reactions occurred as follows: grade 0: 20%, grade 1: 41%, grade 2: 30% and grade 3: 10%. The intention-to-treat analysis of 61 evaluable patients showed an overall response rate of 33%, including 1 (2%) complete and 19 (31%) partial remissions. There were 31% patients with stable and 36% with progressive disease or discontinuation of the therapy before re-staging. The presence of a grade 2 or higher skin rash was associated with a higher likelihood of achieving objective response. Median time to progression was 118 days, with a median overall survival of 213 days. A clinical benefit response was noted in 24 of the evaluable 61 patients (39%). The addition of cetuximab to the combination of gemcitabine and oxaliplatin is well tolerated but does not increase response or survival in patients with metastatic pancreatic cancer.

Fulminant metastatic spread in a patient with an early gastric cancer.

A patient with an early gastric cancer was treated initially by endoscopic submucosal dissection (ESD) at our hospital. The resected specimen showed a depth of submucosal infiltration of more than 500 microm. Therefore, in accordance with the extended criteria with regard to EMR, the patient underwent gastrectomy. The TNM stage was pT1 (sm3), pN0 (0 / 58), cM0, L0, V0, G2 after surgery (UICC stage Ia). At 3 months later ultrasound revealed a new mass in the liver, and biopsy showed a rapidly growing metastasis of the gastric adenocarcinoma. Finally, immunohistochemical analysis of all the lymph nodes of the resected stomach revealed a micrometastasis (3mm) directly under the ESD site. The patient died 6 months later. This clinical case highlights the risk of affected lymph nodes in early gastric cancer and the consequent risk of metastasis which increases with greater depth of infiltration to the submucosa.

[Reflux disease and Barrett's oesophagus - are there gender-specific differences?]. / Refluxerkrankung und Barrett-Osophagus - Gibt es geschlechtsspezifische Unterschiede?

Studies of the prevalence of gastroesophageal reflux disease (GERD) have reported that male gender is an independent risk factor especially for erosive reflux disease (ERD). Non erosive GERD (NERD) is more common in females. The rate of prevalence and severity of reflux symptoms increase in females with age, while among men it peaked between 50 and 70 years and thereafter declined. The gender effect may be caused by differences in parietal cell mass between males and females. Barrett's esophagus is a major complication of gastroesophageal reflux disease and is associated with 30-125 times increased risk of developing carcinoma. Most studies have found gender differences with females significantly less likely to have Barrett's esophagus with a 20-yr age shift between the parallel age specific prevalence curves, for males between the ages of 20 and 59 yr and for females between the ages of 20 and 79 yr. Male predominance for ERD as a precursor to Barrett's esophagus may be partly explain the greater male/female sex ratio for Barrett's esophagus. Female sex hormones may play a protective role. Knowledge of gender-specific differences of reflux disease and Barrett's esophagus may be helpful to improve surveillance and screening strategies, although distinct recommendations are lacking so far .