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Background: Insulinoma is the most common functional pancreatic neuroendocrine tumor and treatment is required to address symptoms associated with insulin hypersecretion. Surgical resection is effective but burdened by high rate of adverse events (AEs). Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) demonstrated encouraging results in terms of safety and efficacy for the management of these tumors. However, studies comparing surgery and EUS-RFA are lacking. Aims: The primary aim is to compare EUS-RFA with surgery in term of safety (overall rate of AEs). Secondary endpoints include: (a) severe AEs rate; (b) clinical effectiveness; (c) patient's quality of life; (d) length of hospital stay; (e) rate of local/distance recurrence; (f) need of reintervention; (g) rate of endocrine and exocrine pancreatic insufficiency; (h) factors associated with EUS-RFA related AEs and clinical effectiveness. Methods: ERASIN-RCT is an international randomized superiority ongoing trial in four countries. Sixty patients will be randomized in two arms (EUS-RFA vs surgery) and outcomes compared. Two EUS-RFA sessions will be allowed to achieve symptoms resolution. Randomization and data collection will be performed online. Discussion: This study will ascertain if EUS-RFA can become the first-line therapy for management of small, sporadic, pancreatic insulinoma and be included in a step-up approach in case of clinical failure.

The close proximity of the endoscopic ultrasound (EUS) probe to the pancreas, coupled with the ease with which a needle can be inserted into a pancreatic lesion, have contributed to the development of EUS-guided therapies for both adenocarcinoma and neuroendocrine pancreatic neoplasms. EUS-guided fine needle injection of different types of drugs, implantation of fiducial markers to facilitate stereotactic body radiation therapy or of radioactive seeds to perform brachytherapy, and the use of different thermal and nonthermal ablation devices and techniques have all been tested in preliminary human studies. This manuscript will present the available evidence accumulated thus far in the field of EUS-guided oncological treatment of pancreatic solid tumors, along with a look into possible future applications.

Objective: The recent outbreak of SARS-CoV-2 infection in Italy has resulted in a sudden and massive flow of patients into emergency rooms, and a high number of hospitalizations with the need for respiratory isolation. Massive admission of patients to the Policlinico "Agostino Gemelli" Foundation of Rome, Italy, determined the need for reengineering the entire hospital. Materials and Methods: In this article, we consider some of the structural and organizational changes that have been necessary to deal with the emergency, with particular reference to non-intensive medicine wards, and the preventive measures aimed at limiting the spread of SARS-CoV-2 infection among hospital staff and patients themselves. Results: 577 staff members were subjected to molecular tests in 1-month period and 3.8% of the total were positive. 636 patients admitted to the COVID-19 pathway were included and analyzed: 45.4% were identified as SARS-CoV-2 positive. More SARS-CoV-2 negative patients were discharged in comparison to SARS-CoV-2 positive patients (59% vs. 41%, respectively). On the other hand, more SARS-CoV-2 positive patients were transferred to ICUs in comparison to SARSCoV-2 negative patients (16% vs. 1%, respectively). Occurrence of death was similar between the two groups, 11% vs. 7%, for SARS-CoV-2 negative and positive patients, respectively. 25% of .80 years old SARS-CoV-2 positive patients died during the hospitalization, while death rate was lower in other age groups (5% in 70-79 years old patients and 0% in remaining age groups). Conclusions: Rapid hospital reengineering has probably had an impact on the management of patients with and without SARS-CoV-2 infection, and on in-hospital mortality rates over the reporting period.

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Pregnancy is characterized by maternal adaptations that are necessary to create a welcoming and hospitable environment for the fetus. Studies have highlighted how the microbiota modulates several networks in humans through complex molecular interactions and how dysbiosis (defined as quantitative and qualitative alterations of the microbiota communities) is related to human pathologies including gynecological diseases. This review analyzed how maternal uterine, vaginal, and gut microbiomes could impact on fetus health during the gestational period. We evaluated the role of a dysbiotic microbiota in preterm birth, chorioamnionitis, gestational diabetes mellitus and pre-eclampsia. For many years it has been hypothesized that newborns were sterile organisms but in the past few years this paradigm has been questioned through the demonstration of the presence of microbes in the placenta and meconium. In the future, we should go deeper into the concept of in utero colonization to better understand the role of microbiota through the phases of pregnancy. Numerous studies in the literature have already showed interesting results regarding the role of microbiota in pregnancy. This evidence gives us the hope that microbiota modulation could be a novel strategy to reduce the morbidity and mortality related to pregnancy complications in the future.

Objective: The management of Inflammatory Bowel Disease (IBD) has changed significantly in recent years, mainly due to the introduction of biologic medications, however, other factors may also have a role. The aim of this study was to evaluate the evolution of IBD admissions, including trends, modality of admission and rates of surgical intervention, in a tertiary care center. Patients and Methods: Hospitalization of patients with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) were identified between 2000 and 2013, using ICD-9-CM codes for IBD, from our hospital database. The following parameters were evaluated for each admission: type of admission (ordinary vs. day care service), mode of admission (elective vs. emergency care, for ordinary admissions only), admission code, surgical procedures and complication rates. Comparison between pre- and post-biologic therapy introduction years was also performed. Results: Between 2000 and 2013 a total of 8834 IBD-related admissions were recorded. Hospitalizations increased linearly reaching a peak in 2006, with a downward trend in the following years. The downward trend was especially marked for patients younger than 40 years. No significant differences in hospitalization trends between CD and UC were recorded. Disease flare represented the cause of hospitalization in approximately 50% of cases. Overall, 10.8% of patients underwent surgery with no difference between the two conditions. Complications occurred in 28.7% of admissions. Conclusions: Hospitalizations for IBD patients have decreased in recent years, especially in younger patients. However, a significant proportion of patients are still admitted to complete diagnostic workup, indicating the need to better implement outpatient services. A clear reduction in surgery occurrence over time could not be observed in our study.

For many years, cell lines and animal models have been essential to improve our understanding of the basis of cell metabolism, signaling, and genetics. They also provided an essential boost to cancer drug discovery. Nevertheless, these model systems failed to reproduce the tumor heterogeneity and the complex biological interactions between cancer cells and human hosts, making a high priority search for alternative methods that are able to export results from model systems to humans, which has become a major bottleneck in the drug development. The emergent human in vitro 3D cell culture technologies have attracted widespread attention because they seem to have the potential to overcome these limitations. Organoids are unique 3D culture models with the ability to self-organize in contained structures. Their versatility has offered an exceptional window of opportunity to approach human cancers. Pancreatic cancers (PCs) patient-derived-organoids (PDOs) preserve histological, genomic, and molecular features of neoplasms they originate from and therefore retain their heterogeneity. Patient-derived organoids can be established with a high success rate from minimal tissue core specimens acquired with endoscopic-ultrasound-guided techniques and assembled into platforms, representing tens to hundreds of cancers each conserving specific features, expanding the types of patient samples that can be propagated and analyzed in the laboratory. Because of their nature, PDO platforms are multipurpose systems that can be easily adapted in co-culture settings to perform a wide spectrum of studies, ranging from drug discovery to immune response evaluation to tumor-stroma interaction. This possibility to increase the complexity of organoids creating a hybrid culture with non-epithelial cells increases the interest in organoid-based platforms giving a pragmatic way to deeply study biological interactions in vitro. In this view, implementing organoid models in co-clinical trials to compare

Bacteroidetes are the largest phylum of Gram-negative bacteria inhabiting our gastrointestinal tract and are considered the leading players of the healthy state and sophisticated homeostasis safeguarded by gut microbiota. Furthermore, specific roles have been attributed to some Bacteroidetes genera in the development of immune dysregulation, systemic disease such as metabolic syndrome and also neurological disorders. Glycoproteins secretion, short fatty acids imbalance, toxins production and molecular mimicry are only a part of the functions exerted by these commensals interacting with the host. The aim of this review is to summarize the current knowledge on the recognized role of Bacteroidetes in physiological functions and pathological networks in order to define the needs for future research and clarify the potential role for targeted microbial therapies.

The coronavirus disease 2019 (COVID-19) pandemic is having a major clinical as well as organisational impact on the national health-care system in Italy, particularly in high-volume hospitals which are usually active for many essential clinical needs, including inflammatory bowel disease (IBD). Here, we report major clinical and organisational challenges at a high-volume Italian IBD centre one month after the start of the Italian government’s restrictions due to the COVID-19 pandemic. All routine follow-up IBD visits of patients in remission were cancelled or rescheduled for 8–12 weeks’ time. However, access to the hospital for therapy or for unstable/relapsing patients was not considered postponable. Everyone attending the centre (e.g. physicians, nurses, administrative personnel and patients) were advised to respect the general recommended rules for hand hygiene and social distancing, to disclose if they had a fever or cough or flu-like symptoms and to wear a surgical mask and gloves. At the entrance of the therapy area, a control station was set up in order to double-check all patients with a clinical interview and conduct thermal scanning. A total of 1451 IBD patients under biotechnological or experimental therapy actively followed in the CEMAD IBD centre were included in the study. About 65% of patients maintained their appointment schedules without major problems, while in 20% of cases planned infusions were delayed because of the patient’s decision or practical issues. About 10% of patients receiving subcutaneous therapy were allowed to collect their medicine without a follow-up visit. Finally, 10% of patients living outside the Lazio region requested access to their therapy at a local centre closer to their home. At present, five patients have been found to be positive for SARS-CoV-2 infection but with minimal symptoms, 22 are in ‘quarantine’ for contact considered to be ‘at risk’ for the infection. Up to now, none of them has experienced significant symptom

Direct endoscopic necrosectomy (DEN) is a cumbersome, time-consuming procedure that can be necessary in cases of infected pancreatic walled-off necrosis (WON) not responding to endoscopic ultrasound (EUS)- guided drainage only. Until now, DEN has been performed with non-dedicated devices, thus requiring multiple, long-lasting sessions to achieve adequate clearance of necrotic content. These results in prolonged hospital stay, increased costs and have potential consequences for patients who must undergo multiple endoscopic interventions under sedation. We report four cases of DEN performed in patients with WON after EUS-guided drainage with the Endorotor system, a new morcellator device specifically designed to perform the procedure.

The proximity of the endoscopic ultrasound (EUS) transducer to the pancreas and the possibility to place needles or other accessories into a target located adjacent to the wall of the GI tract have encouraged researchers to develop various EUS-guided local treatments directed towards pancreatic neuroendocrine neoplasms (PanNENs). The use of pre-operative EUS-guided tattooing or fiducial marker placement to facilitate intraoperative tumor localization has proven effective in reducing operative time of laparoscopic surgeries. To reduce the mortality and morbidity rates of surgical resection, which is presently the mainstay treatment of PanNENs. EUS-guided loco-regional treatments, such as injection of alcohol and radiofrequency ablation have been proposed and results are hitherto promising. The present paper summarizes currently available data in the field of EUS-guided interventions to pancreatic neuroendocrine tumors, as well as possible future applications.

Benign or malignant conditions can present as pancreatic solid lesions (PSLs), and a thorough diagnostic workup is necessary to differentiate them. The need to acquire a tissue sample to reach a definitive diagnosis should be stratified by the findings at multidetector computed tomography (MDCT) with a pancreatic protocol. Tissue biopsy is currently indicated in patients fit for chemotherapy in whom a metastatic tumor or a locally advanced unresectable lesion are discovered. For these patients, EUS-guided tissue acquisition, with fine-needle aspiration (FNA) or biopsy represents the gold standard to provide a definitive cyto- and/or histopathologic diagnosis, with a high rate of accuracy. For resectable PSLs with a nonhypoenhancing MDCT pattern, which is not disease specific, a tissue diagnosis to distinguish benign from malignant etiologies appears mandatory. On the other hand, for hypo-enhancing PSLs, the debate of whether to obtain a preoperative definitive diagnosis still favors direct surgery. However, availability of novel EUS-guided fine-needle biopsy needles, which can ameliorate the negative predictive value of EUS-FNA and allow performance of DNA and RNA whole-genome extraction and RNA sequencing, coupled with the increasing evidence that preoperative neoadjuvant chemotherapy can be of value for these patients may change completely the diagnostic and therapeutic approach to resectable PSLs. These recent breakthroughs suggest the need for a new multidisciplinary consensus meeting to integrate them into the decision-making process assessing the need for preoperative tissue diagnosis in resectable PSLs.

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Nutritional support is a crucial issue in Acute Pancreatitis (AP) management. Recommendations on nutrition in AP are still not completely translated in the clinical practice. We aimed to compare and evaluate the effects of parenteral nutrition (PN) vs oral/enteral nutrition (EN) on several clinical and economic outcomes in AP. This is a retrospective monocentric study conducted in a tertiary care center for pancreatic diseases. The primary outcomes were length of hospital stay (LOS) and associated costs. The secondary outcomes were the use and cost of antibiotics and fluid therapy, and the complication's rates. One hundred seventy-one patients were included from January 2015 to January 2018. Patients were 69 (40.4%) in PN group and 102 (59.6%) in EN group. There was a significant reduction in LOS in EN vs PN group in both mild AP (p < 0.0001), and moderate-severe AP (p < 0.005). There was a significant reduction in the total hospitalization costs in EN group vs PN group in both mild AP (p < 0.0001), and moderate-severe AP (p < 0.005). There was a significant reduction in the total costs of antibiotics and pain therapy in EN vs PN group (p < 0.0001 and p = 0.05, respectively). Finally, a significant reduction in the infected peri-pancreatic fluid collections rate (p = 0.04) was observed in EN vs PN group. The use of EN in AP is associated with substantial clinical and economic benefits. Thus, the application of the standard of care in nutrition and following AP guidelines is the best way to cure patients and improve healthcare system costs.

Helicobacter pylori is one of the most common gastrointestinal infection affecting humans worldwide. Hp colonizes the stomach with preferential trophism for the antrum. Hp infection is associated with the development of a chronic gastritis and subsequently with several gastric diseases such as peptic disease, gastric carcinoma and MALT lymphoma. Moreover, Helicobacter pylori infection has also been reported in literature to be associated with many other extra-gastric conditions including sideropenic anemia, thrombocytopenia, neurological, liver and cardiovascular diseases. For some conditions the association is supported by solid literature data and also by the identification of the possible physiopathogenetic mechanism involved. In other cases, the link is only reported by association studies often with conflicting results. In this context, diabetes mellitus, cardiovascular disorders and liver steatosis have all been reported to be associated with Helicobacter pylori infection. Interestingly, these conditions share many characteristics and they often overlap as they represent the expression of the so called metabolic syndrome. Aim of the review was to summarize the available data regarding the association between Helicobacter Pylori infection and diabetes mellitus, cardiovascular disorders and liver steatosis.

Actinobacteria are one the four major phyla of the gut microbiota and, although they represent only a small percentage, are pivotal in the maintenance of gut homeostasis. During the last decade many studies focused the attention on Actinobacteria, especially on their role both in gastrointestinal and systemic diseases and on their possible therapeutic use. In fact, classes of this phylum, especially Bifidobacteria, are widely used as probiotic demonstrating beneficial effects in many pathological conditions, even if larger in vivo studies are needed to confirm such encouraging results. This review aims to explore the current knowledge on their physiological functions and to speculate on their possible therapeutic role(s) in gastrointestinal and systemic diseases.

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