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Background and Aims Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. Methods We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. Results Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. Conclusions Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.

BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. METHODS: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. RESULTS: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. CONCLUSIONS: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.). ispartof: GASTROENTEROLOGY vol:161 issue:1 pages:185-195 ispartof: location:United States status: published

Studies comparing EUS-guided fine-needle aspiration (EUS-FNA) with EUS-guided fine-needle biopsy (EUS-FNB) for the evaluation of pancreatic neuroendocrine tumors (pNETs) are lacking. We aimed at comparing EUS-FNA with EUS-FNB in terms of Ki-67 proliferative index (PI) estimation capability, cellularity of the samples, and reliability of Ki-67 PI/tumor grading compared with surgical specimens.Patients diagnosed with pNETs on EUS and/or surgical specimens were retrospectively identified. Specimens were re-evaluated to assess Ki-67 PI feasibility, sample cellularity by manual counting, and determination of Ki-67 PI value. Outcomes in the EUS-FNA and EUS-FNB groups were compared. Kendall rank test was used for Ki-67 PI correlation between EUS and surgical specimens. Subgroup analysis including small (≤20 mm), non-functioning pNETs was performed.Three-hundred samples from 292 lesions were evaluated: 69 EUS-FNA cytology and 231 EUS-FNB histology. Ki-67 PI feasibility was similar for EUS-FNA and EUS-FNB (91.3% vs. 95.7%, p = 0.15), while EUS-FNB performed significantly better in the subgroup of 179 small pNETs (88.2% vs. 96.1%, p = 0.04). Rate of poor cellulated (500 cells) specimens was equal between EUS-FNA and EUS-FNB. A significant correlation for Ki-67 PI values between EUS and 92 correspondent surgical specimens was found in both groups, but it was stronger with EUS-FNB (tau = 0.626, p 0.0001 vs. tau = 0.452, p = 0.031). Correct grading estimation was comparable between the two groups (p = 0.482).Our study showed stronger correlation for Ki-67 values between EUS-FNB and surgical specimens, and that EUS-FNB outperformed EUS-FNA in the evaluation of small pNETs. EUS-FNB should become standard of care for grading assessment of suspected pNETs.

OBJECTIVES Type 1 autoimmune pancreatitis (AIP) is a manifestation of immunoglobulin G4-related diseases (IgG4-RD). To evaluate the activity of the disease, the IgG4-RD responder index (RI) has been created. This study evaluated the IgG4-RD RI as prognostic factor of 1-year disease relapse. METHODS Patients diagnosed with type 1 AIP between January 2012 and December 2016, with available magnetic resonance imaging and IgG4 dosage, were enrolled. Immunoglobulin G4-RD RI was calculated at baseline (time 0), and at 3 to 6 and 12 to 18 months after the end of steroid therapy (time 1 and time 2, respectively). RESULTS Thirty-three patients were included in the study. Immunoglobulin G4-RD RI was 8.9 (standard deviation [SD], 3.8) at time 0, 2.4 (SD, 3.1) at time 1 (P < 0.0001 vs time 0), and 4.2 (SD, 3.9) at time 2 (P = 0.02 vs time 1). Fourteen patients who relapsed within 1 year showed a higher mean value of IgG4-RD RI at time 0 (10.9; SD, 4.3) versus 19 who did not (7.4; SD, 2.6; P = 0.012). This difference was observed also at time 2 (6.8 vs 2.1; P = 0.002). CONCLUSIONS Immunoglobulin G4-RD RI correlates with type 1 AIP disease activity, and it predicts disease relapse within 1 year.

Recent advances in technology, information technology, Internet networks, and, more recently, fiber optics in industrialized countries allow the exchange of a huge amount of data, in real time, across the globe. The acquisition of increasingly sophisticated technologies has made it possible to develop telemedicine, by which the specialist's evaluation can be carried out on the patient even remotely. In Italy, this very useful tool, although possible from a technological and information technology point of view, has not been developed because of the lack of clear and univocal rules and of major administrative obstacles related to the Italian Public Health System. To promote telemedicine implementation in Italy, the Italian Society of Clinical Neurophysiology and the Italian Society of Telemedicine together with the National Centre for Telemedicine and New Assistive Technologies of the Italian Higher Institute of Health prepared these inter-society recommendations. Because of potential forensic value of these recommendations, they were prepared considering the current regulations and the General Data Protection Regulation and will provide the basis for a Consensus Conference planned to discuss and prepare National Telemedicine Guidelines.

Background During the lockdown period in Italy, from March 11th to May 4th 2020, a progressive increase in COVID-19 cases occurred in all Italian regions, in particular in the Lombardy Region. The current rise in COVID-19 cases has led to an increasing involvement of hospitals, in order to face the Coronavirus outbreak, shifting healthcare resources towards the management of COVID+ patients. This has led, on the other hand, to a progressive decrease in hospital admissions due to conditions not associated with SARS-CoV2 infection. During COVID-19 outbreak period, it has been observed a decrease in hospital admissions for acute myocardial infarction. This phenomenon put in serious difficulty the clinical management of COVID-free patients with cardiovascular disease, at the beginning of phase 2 (starting from May 4 2020). Purpose In this scenario, we aimed to verify the impact of telemedicine during lockdown, in comparison with the same period in 2019. Materials and method We analyzed 12-lead ECGs recorded by 5000 country pharmacies, evaluated and stored in one telemedicine platform provided by Health Telematic Network (HTN), in cooperation with our Cardiology Department, Federfarma (Pharmacists' National Association), and Italian National Health Institute. Results During the lockdown period, were recorded 6,104 ECGs in territorial pharmacies, compared to 17,280 ECGs done in the same period in 2019. Chest pain symptom represented the cause of recording ECG in 298 patients (4.88%) during the lockdown period, compared to 402 patients (2.33%) in the same period in 2019, with an increase of 109.86%. In the Lombardy Region, during lockdown period, were reported 118 accesses to territorial pharmacies for chest pain (about 39.50% of total cases in Italy). Among these, 36 accesses were in the province of Brescia (about 30.50%), whereas 28 of them were in the province of Bergamo (about 23.73%). Among ECGs performed, 8 showed typical abnormalities of acute myocardial infarction with ST elevation (STEMI, 2.68%) in the lockdown period, compared to 7 STEMIs (1.74%) detected in the same period in 2019, with an increase of 54.17%. These patients were referred to Emergency Department (ED) suddenly, for the therapeutic intervention. Conclusion These data shown that a large number of patients with cardiovascular symptoms preferred to go to territorial pharmacies rather than hospitals during the COVID outbreak period. Telemedicine played a prominent role in managing patients with cardiovascular symptoms at home. Moreover, this service allowed patients with STEMI to access to the hospitals faster, avoiding the risks of a serious diagnostic delay. Furthermore, by analyzing the data of Lombardy Region, it was possible to show how a significant component of access to local pharmacies for chest pain occurred in the region most affected by the COVID-19 outbreak. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): University of Brescia Number of ECGs recorded for chest painData recorded in Lombardy Region

Background and study aims Little is known about outcomes of biliopancreatic endosonography (EUS) in patients with surgically altered upper gastrointestinal (gastrointestinal) anatomy. We aimed to assess the rate of procedural success and EUS-related adverse events (AEs), according to post-surgical anatomies. Patients and methods Retrospective study including patients with post-surgical altered upper gastrointestinal anatomy who underwent EUS for evaluation of the biliopancreatic region between January 2008 and June 2018 at eight European centers. Results Of 242 patients (162 males, mean age 66.4 ± 12.5), 86 had (35.5 %) Billroth II, 77 (31.8 %) pancreaticoduodenectomy, 23 (9.5 %) Billroth I, 19 (7.9 %) distal esophagectomy, 15 (6.2 %) total gastrectomy, 14 (5.8 %) sleeve gastrectomy, and eight (3.3 %) Roux-en-Y. Sleeve gastrectomy, Billroth I, and pancreaticoduodenectomy were associated with high rates of success (100 %, 95.7 %, and 92.2 %, respectively). Visualization of the head of the pancreas was significantly impacted by total gastrectomy, Billroth II, and Roux-en-Y (success rates 6.7 %, 53.7 %, and 57.1 %, respectively). Examination of the pancreatic body and tail was impaired in esophagectomy and total gastrectomy (82.4 % and 71.4 %, respectively). Technical success and diagnostic accuracy of EUS-guided tissue acquisition (EUS-TA) was 78.2 % and 71.3 % (95 % CI, 60.6–80.5), respectively. Four (1.6 %) AEs were observed: one mucosal tearing in a Billroth II patient, one cardiac arrest in a distal esophagectomy patient, one bleed after EUS-TA in a Billroth I patient, and one acute pancreatitis after EUS-TA in a sleeve gastrectomy patient. Conclusions The yield of bilio-pancreatic EUS is dependent on lesion location and surgery type. Before considering EUS in these patients, one must carefully consider whether the lesion may be approachable by EUS.

Objectives: Post-endoscopic retrograde cholangiopancreatography (ERCP) acute pancreatitis (PEP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. We aimed to investigate whether statins and chronic ASA intake are associated with lower risk of PEP. Methods: An international, multicenter, prospective cohort study. Consecutive patients undergoing ERCP in seven European centers were included. Patients were followed-up to detect those with PEP. Multivariate analysis by means of binary logistic regression was performed, and adjusted odds ratios (aORs) were calculated. Results: A total of 1150 patients were included, and 70 (6.1%) patients developed PEP. Among statins users, 8.1% developed PEP vs. 5.4% among non-users (P=0.09). Multivariate analysis showed no association between statin use and PEP incidence (aOR 1.68 (95% CI 0.94–2.99, P=0.08)). Statin use had no effect on severity of PEP, being mild in 92.0% of statin users vs. 82.2% in non-statin users (P=0.31). Chronic ASA use was not associated with PEP either (aOR 1.02 (95% CI 0.49–2.13), P=0.96). Abuse of alcohol and previous endoscopic biliary sphincterotomy were protective factors against PEP, while >1 pancreatic guidewire passage, normal bilirubin values, and duration of the procedure >20minutes, were risk factors. Conclusions: The use of statins or ASA is not associated with a lower risk or a milder course of PEP.

Introduction: After a failed percutaneous ultrasound (US)-guided sampling, it is recommended that endoscopic ultrasound (EUS)-guided tissue acquisition (TA) be performed for non-resectable solid pancreatic lesions according to the European Federation of Societies for Ultrasound in Medicine and Biology. However, the diagnostic performance of EUS-guided TA in this setting is unknown. Methods: We retrospectively analyzed the performance and safety of EUS-guided TA in patients with a previous failed percutaneous biopsy. We also evaluated the diagnostic delays between the percutaneous approach and EUS diagnosis. Results: Over a period of 2 years, 49 patients were identified (29 males, mean age 65 years). The reasons for failure of percutaneous sampling were inadequate samples in 25 (52.1%) cases and lesions that were not visible or targetable in 24 (47.9%) cases. In one case, EUS-guided TA was not performed because of the interposition of a metallic biliary stent. No adverse events were recorded for both the percutaneous and EUS approaches. The median diagnostic delay was 12 days. Overall, the sensitivity and accuracy of EUS-guided TA were 92.7 and 93.7%, respectively. A subgroup analysis examined cases with inadequate samples obtained with the percutaneous approach, and the sensitivity and accuracy of EUS-guided TA were 85.7 and 88%, respectively. Conclusion: EUS-guided TA is safe and accurate for the diagnosis of pancreatic lesions after a previous inconclusive percutaneous approach.

Background & Aims Several endoscopic methods have been proposed for the treatment of large biliary stones. We assessed the comparative efficacy of these treatments through a network meta-analysis. Methods Nineteen randomized controlled trials (2752 patients) comparing different treatments for management of large bile stones (>10 mm) (endoscopic sphincterotomy, balloon sphincteroplasty, sphincterotomy followed by endoscopic papillary large balloon dilation [S+EPLBD], mechanical lithotripsy, single-operator cholangioscopy [SOC]) with each other were identified. Study outcomes were the success rate of stone removal and the incidence of adverse events. We performed pairwise and network meta-analysis for all treatments, and used Grading of Recommendations, Assessment, Development, and Evaluation criteria to appraise the quality of evidence. Results All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03–1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07–1.45], vs S+EPLBD [RR, 1.23; range, 1.06–1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14–1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding were the most frequent adverse events. Conclusions Among patients with large bile stones, cholangioscopy represents the most effective method, in particular in patients with larger (>15 mm) stones, whereas S+EPLBD could represent a less expensive and more widely available alternative.

Interventional endoscopic ultrasound (EUS) is a rapidly expanding field with a wide variety of indications, including different drainage procedures and delivery of locoregional treatment mainly for pancreatic solid tumors. Transgastric or transduodenal gallbladder drainage in high-risk patients with acute cholecystitis or biliary decompression in patients with unresectable distal biliary malignant obstruction who failed endoscopic retrograde colangiography is one of the newest areas of EUS-guided intervention. The large-caliber lumen apposing metal stents placed during these procedures allow direct endoscopic gallbladder access and the possibility of performing gallstone treatment or resection of mucosal polyps. The current review presents the indications of endoscopic gallbladder interventions and discusses the results of available studies, foreseeing future potential applications.

OBJECTIVES Chronic asymptomatic pancreatic hyperenzymemia (CAPH) was described as a benign disease. However, we already described clinically relevant findings requiring surgery or follow-up in half of the subjects. The aim of this study was to evaluate the long-term outcome of CAPH in terms of symptoms and evolution toward chronic pancreatitis. METHODS Subjects previously enrolled in the first phase of the study (from 2005 to 2010) were reinvestigated from December 2013 to January 2017 with a phone call ± magnetic resonance cholangiopancreatography with secretin stimulation. RESULTS A total of 133 subjects were eligible for the follow-up study (75 males, 58 females; age, 48.4 [standard deviation {SD}, 14] years); 24 (18%) of them dropped out. During a mean follow-up of 9.3 (SD, 5.2) years after the first diagnosis of CAPH, no episode of acute pancreatitis or abdominal pain was reported. Sixty-three subjects (58%) of 109 underwent magnetic resonance cholangiopancreatography with secretin stimulation with a mean follow-up of 5.7 [SD, 3.1] years (range, 1-11 years). Secretin stimulation-MRCP resulted unchanged in 54 (90%) of 60 subjects, worsened in 3 (5%) and improved in 3 (5%). Two subjects died from causes unrelated to pancreatic disease. CONCLUSIONS Excluding subjects with a pancreatic disease at index magnetic resonance imaging, CAPH is a benign condition.

BACKGROUND: Innovative approaches to improve diagnostic yield of endoscopic ultrasound-guided tissue acquisition (EUS-TA) have focused on needle design with development of fine-needle biopsy (FNB) needles with microcore-acquisition technology. Recently, a 20-gauge (20G) antegrade-cutting-side-bevelled biopsy needle (ProCore®) was developed for EUS-TA, but data about its diagnostic performance and histological capability are scant. OBJECTIVES: We assessed the diagnostic performance and histologic retrieval rate of a new 20G antegrade-cutting-side-bevelled biopsy needle compared with a 22G reverse-side-bevelled needle for EUS sampling of solid pancreatic lesions. PATIENTS AND METHODS: A retrospective analysis of 238 consecutively collected patients who underwent EUS-TA using a 20G or a 22G ProCore® needle, without rapid on-site evaluation (ROSE), was conducted at two centres. Sensitivity, specificity, positive predictive value and negative predictive value were calculated. Histologic tissue retrieval was evaluated applying a scoring system for each case. RESULTS: Sensitivity and specificity were estimated as 98.4–100% in the 20G-, and 94.9–100% in the 22G-needle groups, respectively (p > 0.99). The 20G procured more histologic-grade tissues (92.6% vs 49.5%, p

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure with a relatively high rate of adverse events. Data on training of operators and fulfillment of quality indicators in Italy are scarce. The goal of this study was to assess the overall quality of ERCP in Italy compared to international standards. Patients and methods This was a prospective, observational study from different Italian centers performing ERCP. Operators answered a questionnaire, then recorded data on ERCPs over a 1-to 3-month period. Results Nineteen Italian centers participated in the study. The most common concern of operators about training was the lack of structured programs. Seven/19 centers routinely used conscious sedation for ERCP. Forty-one experienced operators and 21 trainees performed 766 ERCPs: a successful deep biliary cannulation in native-papilla patients was achieved in 95.1 % of cases; the post-ERCP pancreatitis (PEP) rate was 5.4 % in native-papilla patients; cholangitis rate was 1.0 %; bleeding and perforation occurred in 2.7 % and 0.4 % of the patients, respectively. Conclusions This study revealed that, overall, ERCP is performed in the participating Italian centers meeting good quality standards, but structured training and sedation practice are still subpar. The bleeding and perforation rate slightly exceeded the American Society of Gastrointestinal Endoscopy indicator targets but they are comparable to the reported rates from other international surveys.

On contrast-enhanced imaging studies, nonhypovascular (i. e., isovascular and hypervascular) patterns can be observed in solid pancreatic lesions (SPLs) of different nature, prognosis, and management. We aimed to identify endoscopic ultrasound (EUS) features of nonhypovascular SPLs associated with malignancy/aggressiveness. The secondary aims were EUS tissue acquisition (EUS-TA) outcome and safety in this setting of patients. This prospective observational study included patients with nonhypovascular SPLs detected on cross-sectional imaging and referred for EUS-TA. Lesion features (size, site, margins, echotexture, vascular pattern, and upstream dilation of the main pancreatic duct) were recorded. Malignancy/aggressiveness was determined by evidence of carcinoma at biopsy/surgical pathology, signs of aggressiveness (perineural invasion, lymphovascular invasion, and/or microscopic tumor extension/infiltration or evidence of metastatic lymph nodes) in the surgical specimen, radiologic detection of lymph nodes or distant metastases, and/or tumor growth 5 mm/6 months. Uni- and multivariate analyses were performed to assess the primary aim. A total of 154 patients with 161 SPLs were enrolled. 40 (24.8 %) lesions were defined as malignant/aggressive. Irregular margins and size 20 mm were independent factors associated with malignancy/aggressiveness (p 0.001, OR = 5.2 and p = 0.003, OR = 2.1, respectively). However, size20 mm was not significant in the subgroup of other-than-neuroendocrine tumor (NET) lesions. The EUS-TA accuracy was 92 %, and the rate of adverse events was 4 %. Irregular margins on EUS are associated with malignancy/aggressiveness of nonhypovascular SPLs. Size20 mm should be considered a malignancy-related feature only in NET patients. EUS-TA is safe and highly accurate for differential diagnosis in this group of patients.ZIEL: In kontrastverstärkten Bildgebungsstudien werden in soliden Pankreasläsionen (SPLs) nicht hypovaskuläre (d. h. isovaskuläre und hypervaskuläre) Muster unterschiedlichsten Ursprungs, Prognose und Behandlung beobachtet. Unser Ziel war die Bestimmung der Merkmale des endoskopischen Ultraschalls (EUS) bei nicht hypovaskulären SPLs, die mit Malignität/Aggressivität assoziiert sind. Die sekundären Ziele waren das Outcome der EUS-Gewebeaufnahme (EUS-TA) und die Patientensicherheit. Diese prospektive Beobachtungsstudie umfasste Patienten mit nicht hypovaskulären SPLs, die in einem Schnittbildverfahren entdeckt wurden und zur EUS-TA einbestellt wurden. Läsionsmerkmale (Größe, Lage, Ränder, Echotextur, Gefäßmuster und stromaufwärts gerichtete Dilatation des Hauptpankreasgangs) wurden erfasst. Die Malignität/Aggressivität wurde durch Nachweis eines Karzinoms in der Biopsie/Pathologie, durch Zeichen von Aggressivität (perineurale Invasion, lymphovaskuläre Invasion und/oder mikroskopische Tumorausdehnung/-infiltration oder Nachweis metastasierter Lymphknoten) in der chirurgischen Probe, durch den radiologischer Nachweis von Lymphknoten oder entfernten Metastasen und/oder durch Tumorwachstum 5 mm in 6 Monaten definiert. Zur Beurteilung des Primärziels wurden uni- und multivariate Analysen durchgeführt. Insgesamt wurden 154 Patienten mit 161 SPLs aufgenommen. 40 (24,8 %) Läsionen wurden als maligne/aggressiv definiert. Unabhängige, mit Malignität/Aggressivität assoziierte Faktoren waren unregelmäßige Ränder (p 0,001; OR = 5,2) und eine Größe 20 mm (p = 0,003; OR = 2,1). Allerdings war der Faktor Größe 20 mm in der Untergruppe der nicht neuroendokrinen Tumor (NET) -Läsionen nicht signifikant. Die Genauigkeit der EUS-TA betrug 92 % und die Rate der unerwünschten Ereignisse 4 %. Unregelmäßige Ränder in EUS sind mit Malignität/Aggressivität von nicht hypovaskulären SPLs assoziiert. Eine Größe 20 mm sollte nur bei NET-Patienten als Marker für Malignität angesehen werden. Die EUS-TA ist sicher und von hoher Genauigkeit für die Differenzialdiagnose in dieser Patientengruppe.

We aimed to assess factors impacting the endoscopic minor papilla sphincterotomy (EMPS) success rate, clinical efficacy, and safety in a large cohort of patients with symptomatic pancreas divisum (PD).Retrospective study including patients with PD referred to the Pancreas Institute of Verona from May 2009 to May 2020 to undergo EMPS. The whole population was analyzed to assess EMPS technical success, defined as the rate of deep cannulation of the dorsal duct. Patients treated for recurrent pancreatitis (RP) with a minimum follow-up of 1 year were included to evaluate the clinical efficacy, defined as resolution or significant reduction of acute pancreatitis (AP) episodes. Safety was defined as the rate of procedure-related adverse events (AEs) according to an international lexicon. The effects of the main determinants on study outcomes were evaluated.Overall, 106 patients were evaluated. Technical success was obtained in 87 (82.1%). The presence of pancreatic calcifications was associated with failure (p 0.0001). Clinical efficacy was evaluated in 59 patients. Resolution/reduction of AP episodes after EMPS was observed in 93% of patients over a median follow-up of 49 months (IQR 37-92). Smoking habit was associated with AP recurrence (p = 0.026). The overall AE rate was 14.9%, with post-ERCP pancreatitis as the most common complication (12.6%).In our study, performed at a tertiary center, EMPS showed satisfactory technical success and an acceptable safety profile. If confirmed by prospective multicenter studies, EMPS could become the standard of care for the treatment of RP in PD.

A 57-year-old woman with epigastric pain was diagnosed with a 6-cm abdominal cystic lesion of unclear origin on cross-sectional imaging. Endoscopic ultrasound (EUS) demonstrated a unilocular cyst located between the pancreas, gastric wall, and left adrenal gland, with a regular wall filled with dense fluid with multiple hyperechoic floating spots. A 19-G needle was used to puncture the cyst, but no fluid could be aspirated. Therefore, EUS-guided through-the-needle biopsy (EUS-TTNB) was performed. Histological analysis of the retrieved fragments revealed a fibrous wall lined by “respiratory-type” epithelium with ciliated columnar cells, consistent with the diagnosis of a bronchogenic cyst. Laparoscopic excision was performed, and the diagnosis was confirmed based on the findings of the surgical specimen. Abdominal bronchogenic cysts are extremely uncommon, and a definitive diagnosis is commonly obtained after the examination of surgical specimens due to the lack of pathognomonic findings on cross-sectional imaging and poor cellularity on EUS-guided fine-needle aspiration cytology. EUS-TTNB is useful for establishing a preoperative histological diagnosis, thus supporting the decision-making process.

Background and study aims COVID-19 has dramatically impacted endoscopy practice because upper endoscopy procedures can be aerosol-generating. Most elective procedures have been rescheduled. Endoscopic retrograde cholangiopancreatography (ERCP) is frequently performed in emergency or urgent settings in which rescheduling is not possible. We evaluated the impact of the COVID-19 pandemic on ERCP in Italy during the SARS-CoV-2 lockdown, in areas with high incidence of COVID-19. Patients and methods We performed a retrospective survey of centers performing ERCP in high COVID-19 prevalence areas in Italy to collect information regarding clinical data from patients undergoing ERCP, staff, case-volume and organization of endoscopy units from March 8, 2020 to April 30, 2020. Results We collected data from 31 centers and 804 patients. All centers adopted a triage and/or screening protocol for SARS-CoV-2 and performed follow-up of patients 2 weeks after the procedure. ERCP case-volume was reduced by 44.1 % compared to the respective 2019 timeframe. Of the 804 patients undergoing ERCP, 22 (2.7 %) were positive for COVID-19. Adverse events occurred at a similar rate to previously published data. Of the patients, endoscopists, and nurses, 1.6 %, 11.7 %, and 4.9 %, respectively, tested positive for SARS-CoV-2 at follow up. Only 38.7 % of centers had access to a negative-pressure room for ERCP. Conclusion The case-volume reduction for ERCP during lockdown was lower than for other gastrointestinal endoscopy procedures. No definitive conclusions can be drawn about the percentage of SARS-CoV-2-positive patients and healthcare workers observed after ERCP. Appropriate triage and screening of patients and adherence to society recommendations are paramount.

Background: The validation of prognostic indices might prove instrumental for optimal management of motoneuron disease (MND) patients. Aim: To test the role of PaO2, HCO3-, and vital capacity (VC) at diagnosis in predicting the prognosis of MND patients, both in terms of time to the start of non-invasive ventilation (NIV) and to death. Patients and Methods: We retrospectively analyzed the records of 192 MND patients followed-up in our dedicated MND clinic. All patients underwent blood gas analysis and spirometry (VC, both in the sitting and supine position) at the time of diagnosis; time to non-invasive ventilation (NIV) and death was recorded. Kaplan-Meier curves were built and differences between groups based on predefined thresholds were analyzed by the log-rank test using GraphPad Prism software; p-values Results: The figure shows the Kaplan-Meier curves for time to NIV. All curves were significantly different for patients above and below the predefined thresholds. Median time to death was different for patients with HCO3- above and below the threshold of 26 mmol/L (29 and 68 months, respectively; p Conclusions: As expected, PaO2 and VC (particularly in the supine position) at diagnosis are relevant prognostic determinants in MND patients. HCO3-, that can be easily measured in venous blood, is emerging as a reliable prognostic index in these patients.

Background: Up-front surgery followed by postoperative chemotherapy remains the standard paradigm for the treatment of patients with resectable pancreatic cancer. However, the risk for positive surgical margins, the poor recovery after surgery that often impairs postoperative treatment, and the common metastatic relapse limit the overall clinical outcomes achieved with this strategy. Polychemotherapeutic combinations are valid options for postoperative treatment in patients with good performance status. liposomal irinotecan (Nal-IRI) is a novel nanoliposome formulation of irinotecan that accumulates in tumor-associated macrophages improving the therapeutic index of irinotecan and has been approved for the treatment of patients with metastatic pancreatic cancer after progression under gemcitabine-based therapy. Thus, it remains of the outmost urgency to investigate introduction of the most novel agents, such as nal-IRI, in perioperative approaches aimed at increasing the long-term effectiveness of surgery. Methods: The nITRO trial is a phase II, single-arm, open-label study to assess the safety and the activity of nal-IRI with fluorouracil/leucovorin (5-FU/LV) and oxaliplatin in the perioperative treatment of patients with resectable pancreatic cancer. The primary tumor must be resectable with no involvement of the major arteries and no involvement or 2, oxaliplatin 60 mg/m2, leucovorin 200 mg/m2, and 5-fluorouracil 2400 mg/m2, days 1 and 15 of a 28-day cycle. The primary objective is to improve from 40% to 55% the proportion of patients achieving R0 resection after preoperative treatment. Discussion: The nITRO trial will contribute to strengthen the clinical evidence supporting perioperative strategies in resectable pancreatic cancer patients. Moreover, this study represents a unique opportunity for translational analyses aimed to identify novel immune-related prognostic and predictive factors in this setting. Trial registration Clinicaltrial.gov : NCT03528785. Trial registration data: 1 January 2018 Protocol number: CRC 2017_01 EudraCT Number: 2017-000345-46

Background Painless chronic pancreatitis (CP) is a rare form of the disease. Aim To evaluate the prevalence and the characteristics of this overlooked form of pancreatitis. Methods Patients with a diagnosis of CP and absence of pain were selected, excluding patients suffering from autoimmune pancreatitis. Clinical data, imaging features, and exocrine and endocrine function were therefore analyzed. Results Among 781 patients observed between 2010 and 2016, 74 patients with painless CP (9.5%) were selected. Mean age at diagnosis was 60.8 (SD 10.8) years. 38(51%) individuals did not report any symptom, 36(49%) were affected by symptoms other than pain. Pancreatic calcifications were diagnosed in 70 patients (95%), main pancreatic duct dilation in 55(74%), and pancreatic atrophy in 39(53%).Thirty-six patients (55%) had severe exocrine pancreatic insufficiency(EPI). Diabetes was observed in 34 out of 72 patients (47%). During a mean follow-up of 2.9 (SD 2.8) years, only a mild pancreatitis was diagnosed in a 71-year old female. No patient underwent endoscopic treatment or surgery, developed pancreatic cancer or died. Conclusions In a tertiary center painless CP is observed in 10% of cases, and it is frequently associated with EPI. The probability of onset of pain is very low in a short-term follow-up.

Background Data on the reliability of the Ki-67 index and grading calculations from endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic neuroendocrine tumors (PanNETs) are controversial. We aimed to assess the accuracy of these data compared with histology. Methods Cytological analysis from EUS-FNA in patients with suspected PanNETs (n = 110) were compared with resection samples at a single institution. A minimum of 2000 cells were considered to be adequate for grading. Correlation and agreement between cytology and histology in grading and Ki-67 values, respectively, were investigated. Secondary outcomes included the diagnostic performance of EUS-FNA. Results EUS-FNA samples were adequate for PanNET diagnosis and PanNET grading in 98/110 (89.1 %) and 77/110 (70.0 %) patients, respectively; thus, 77 samples were adequate for comparing cytology vs. histology. There were 67 (62.0 %), 40 (36.4 %), and 1 (0.9 %) patients with a final diagnosis of G1, G2, and G3 tumors, respectively. EUS-FNA grading was concordant with surgical pathology in 81.8 % of patients; under- and overgrading occurred in 15.6 % and 2.6 %, respectively. The overall level of agreement for grading was moderate (Cohen’s κ = 0.59, 95 % confidence interval [CI] 0.34 – 0.78). Spearman’s rho for Ki-67 in tumors ≤ 20 mm and > 20 mm was strong and moderate, respectively (rho = 0.68, 95 %CI 0.47 – 0.83; rho = 0.59, 95 %CI 0.35 – 0.75). The Bland – Altman plot showed that the Ki-67 values were comparable and reproducible between the two measurements. Conclusions Although they were not available for a significant number of patients, grading and Ki-67 values from cytology correlated with histology moderately to strongly.

Patient: Female, 65 Final Diagnosis: Acquired uterine arteriovenous malformation Symptoms: Vaginal bleeding Medication: — Clinical Procedure: Wait and see Specialty: Obstetrics and Gynecology Objective: Rare disease Background: Uterine arteriovenous malformation (AVM) is an uncommon lesion characterized by an abnormal connection between arterial and venous circulation that can be congenital or acquired. Acquired uterine AVMs are generally traumatic and follow delivery, abortion, curettage, or uterine surgery. Case Report: A 45-year-old female who was gravida 1 para 0 presented to our hospital with severe vaginal bleeding. Two weeks before, the patient underwent therapeutic abortion. At admission, a transvaginal ultrasound showed an unclear intrauterine lesion that spread out to the myometrium. Color Doppler evaluation demonstrated an elevated color score. Beta human chorionic gonadotropin (beta-hCG) levels were measured at admission and daily repeated, with a progressive decrease of values up to a negative level. A pelvic magnetic resonance imaging described an area of tubular and tortuous structures involving the myometrium. A computed tomography angiography confirmed the presence of a lesion infiltrating the endometrium and myometrium containing arteriovenous structures with a highly enhanced effect. Despite these findings, the patient was clinically stable. A diagnosis of uterine AVM was made and, after accurate counselling with the patient, she was discharged and underwent “watch and wait” management. After 35 days, the patient had a follow-up ultrasound that showed a complete resolution of the uterine lesion. Conclusions: AVM should be considered in the presence of heavy and sudden vaginal bleeding in a patient with risk factors for acquired AVM. A color Doppler ultrasound scan should be performed as the first approach and an expectant management should be taken into account especially with a patient of childbearing age and hemodynamic instability.

Background Knowledge concerning the predictors of social security benefits and the proportion of Multiple Sclerosis (MS) patients receiving these benefits is very limited. Objective To estimate the likelihood of receiving social security benefits for Italian MS patients. Methods From September 2014 to November 2015, we interviewed MS outpatients from two Italian MS clinics to collect information regarding their personal data, clinical and working history, and access to social security benefits. We performed both univariate and multivariable analyses to evaluate the predictors for receiving social security benefits. Results We interviewed 297 patients, with a mean age of 49.5 (± 10.7) years; 71.4% were females. About 73% of patients had a relapsing-remitting (RR) course and the median EDSS score was 2.5 (IQR 1.5–6). About 75% of MS patients received a full exemption from co-payments, while the proportions of people who enjoyed each of the other social security benefits were lower, ranging from 8.8% (car adaptation) to 32% (disable badge). At multivariable analysis, the probability of obtaining each of the benefits was significantly associated with the EDSS score: walking aids (OR 3.9), care allowance (OR 3.6), disabled badge (OR 2.4), exemption from co-payment (OR 1.6) and allowed off work permit (OR 1.7). Only the probability of obtaining an allowed off work permit was also influenced by comorbidities (OR 2.9) and a higher education (OR 2.2). Conclusion Except for full exemption from co-payments, the proportions of MS patients who enjoyed social security benefits seem to be limited in our study sample. The EDSS score is the strongest predictor of the probability of receiving all the benefits. Only a small proportion of patients received care allowance and working permits, probably because such benefits are only granted to people with a high level of disability. On the other hand, the low proportion of patients who enjoyed fiscal benefits for home and car adaptations could have been influenced by the way such benefits are granted in our country.

Cerebral air embolism is caused by gas bubbles in the vascular system. These bubbles can cause cerebral ischemia by obstructing encephalic blood vessels. It is frequently associated with blunt and penetrating chest trauma as well as iatrogenic interventions. Lung trauma involving laceration of the respiratory tract, lung parenchyma, and blood vessels may result in direct communication of these structures, driving air or gas into the pulmonary venous system. We report a case of a blunt chest trauma that led to massive arterial air embolism that was possible to recognize with the help of postmortem computed tomographic scan examination.

Background and Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, –1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.)

Background ITALUNG is contributing to the European evaluation of low-dose CT (LDCT) screening for lung cancer (LC). Methods Eligible subjects aged 55–69 years, smokers or ex-smokers (at least 20 pack-years in the last 10 years), were randomised to receive an annual invitation for LDCT screening for 4 years (active group) or to usual care (control group). All participants were followed up for vital status and cause of death (at the end of 2014) and LC incidence (at the end of 2013). Pathological and clinical information was collected from the Tuscan Cancer Registry data. Results 1613 subjects were randomly assigned to the active group and 1593 to the control group. At the end of the follow-up period 67 LC cases were diagnosed in the active group and 71 in the control group (rate ratio (RR)=0.93; 95% CI 0.67 to 1.30). A greater proportion of stage I LC was observed in the active group (36% vs 11%, p Conclusions Despite the lack of statistical significance, the ITALUNG trial outcomes suggest that LDCT screening could reduce LC and overall mortality. Moreover, the comparison of the number of LC cases diagnosed in the two groups does not show overdiagnosis after an adequate follow-up period. A pooled analysis of all European screening trials is advocated to assess the benefit-to-harm ratio of LDCT screening and its implementation in public health settings. Trial registration number Results, NCT02777996.

OBJECTIVES This study aimed to evaluate the clinical and radiological features and clinical outcomes of paraduodenal pancreatitis (PP). METHODS A final diagnosis of PP was based on surgical specimens in resected patients and on imaging in nonoperated patients. Clinical, radiological, and pathological data were collected and reevaluated. RESULTS We studied 120 patients, 97.5% of whom were drinkers and 97.5% were smokers. Symptoms at clinical onset were acute pancreatitis in 78 patients (65%) and continuous pain in 68 patients (55.8%). Other symptoms were vomiting (36.7%), weight loss (25.8%), and jaundice (11.7%). Cystic variant was diagnosed in 82 patients (68.0%), and solid variant was diagnosed in 38 patients (32.0%). Pure and diffuse forms were observed in 22 (18.3%) and 98 (81.7%) patients, respectively. Pancreatic calcifications were present at clinical onset in 5.0% of the patients and in 61.0% at the end of follow-up. Somatostatin analogs were used in 13 patients (10.8%), and 81 patients (67.0%) underwent surgery. CONCLUSIONS The clinical profile of PP was found to be middle-aged men who were heavy drinkers and smokers with painful pancreatitis and was associated with vomiting and weight loss. In nonresponders, alcohol withdrawal and medical therapy can be proposed as a first-line treatment, and surgery as a second-line treatment.

Pancreatic enucleation (PE) is a viable option for the removal of non-malignant pancreatic masses leading to complete preservation of organ function. Nevertheless, PE is associated with substantial rates of post-operative pancreatic fistula (POPF), particularly when the mass is close to the main pancreatic duct (MPD). Preoperative stenting of the MPD may prevent its injury when performing PE. This paper describes a novel technique of “deep” PE preceded by endoscopic stenting of the MPD. From January 2017 to May 2019, patients with small pancreatic neuroendocrine tumors proximal to the MPD were candidates for PE with previous stenting of the MPD at the University of Verona, Italy, and at the UCLA Medical Center, Los Angeles, California. The endoscopic stenting was scheduled either the day before or 3 weeks before surgery, depending on the participating institute. Ten patients were included in this pilot study. The endoscopic procedure was successful and well tolerated in all cases. Open, laparoscopic and robotic PE were performed. Seven patients had surgical complications. Among these, six developed a post-operative pancreatic fistula (POPF), but neither grade C fistulas nor disruptions of the MPD were detected. At pathology, a low grade pancreatic neuroendocrine tumor was confirmed in all cases. In the setting of high-volume centers, this procedure is safe, and it is associated with acceptable short-term surgical morbidity. The preoperative stenting of the MPD might extend the surgical indications for PE.

Introduction despite good progress in the management of patients with atrial fibrillation (AF), this disease remains one of the major cause of stroke, heart failure, sudden death and cardiovascular morbidity. Screening for silent AF is recommended in high risk population, especially in elderly, but often it is not applied for the absence of medical prescriptions or long waiting times Purpose to evaluate the effectiveness of a remote monitoring through ECG Holter and 12-lead ECG provided by a network of pharmacies across the Country for the screening of AF Methods according to a Ministerial Decree, from 2010 authorized pharmacies may provide specialist outpatient care services. Health Telematic Network, in collaboration with our Cardiology University Department and Federfarma (National Association of Pharmacists), has installed in 4,008 authorized pharmacies across the Country a telematic network connected to a single Telemedicine platform where cardiologists were available for tele-consulting. In order to identify silent or symptomatic AF, 12-lead ECG and ECG Holter monitoring were performed in patients with episodes of palpitation, syncope or pre-syncope or with a history of AF. Informations regarding lenght of AF episodes, mean heart rate and anticoagulant therapy were collected Results From Jan 2017 to Dec 2018 a total of 31,156 ECG Holter monitoring were performed (46% male, mean age 61 years). Among these records, 2390 (8%) showed paroxysmal or persistent AF (53% male, mean age 77±10 years). The lenght of AF episodes was greater of 6 minutes in 14% cases and mean heart rate was greater of 90 bpm in 406 patients (17%). History of AF was not previously known in 669 patients (28%). None of this subgroup of patients and only 18% of patients with known paroxysmal AF were taking anticoagulant therapy. In the same period 196,349 ECG were performed (mean age 78 years) and 17,088 have been carried out in patients aged 65 years or older. Among these group of patients, 831 records showed unknown AF (5%): 356 (43%) high ventricular rate AF, 385 (46%) medium ventricular rate AF and 90 (11%) low ventricular rate AF. All the patients with unknown AF episodes or with frequent high ventricular rate AF episodes were referred to their General Practitioner or Cardiologist for urgent evaluation and therapeutic management. Conclusion our data confirm the important role of a single telematic network in which health care services can be provided timely by authorized pharmacies across all the Country to promote early diagnosis and treatment of AF, then resulting in a likely positive impact on related cardiovascular events

Background and Objectives: Despite rarely, serous cystic adenoma (SCA) can assume a pseudo-solid aspect mimicking other pancreatic neoplasm as neuroendocrine tumor. EUS-FNA cytology has low diagnostic accuracy due to the scant cellularity of the collected samples. Histological diagnosis is usually made after resection. Recently, end-cutting needles for EUS-fine-needle biopsy (EUS-FNB), which obtain tissue cores by penetrating the lesions, have been developed. We aimed to assess the capability of EUS-FNB with SharkCore™ needles in the preoperative diagnosis of serous cystic adenoma pseudo-solid-appearing on imaging (Sa-SCA). Materials and Methods: Between January 2016 and January 2018, data from consecutive adult patients, who were referred for EUS-FNB of a solid pancreatic lesion and were diagnosed with having SCA, were retrieved from a single-center institutional database. Results: Two patients were excluded because of microcystic aspect at EUS. Histological diagnosis of SCA was made by EUS-FNB in the remaining 7 patients (5 females; mean age of 62.5 years). Lesions (mean size of 19.8 mm) were hypervascular on cross-sectional imaging, slightly hyperdense magnetic resonance imaging with T2-weighted images can, and negative at 68Ga-somatostatin receptor positron emission tomography and 18fluoro-deoxyglucose positron emission tomography. EUS-FNB samples were judged adequate for a definitive diagnosis in all cases, achieving specimens suitable for histological evaluation and several ancillary stains. Histochemical positivity for periodic acid-Schiff (PAS) and PAS with diastase digestion was observed in 7/7 cases. Immunohistochemical positivity for α-inhibin (7/7), GLUT1 (6/6), MUC6 (5/5), and negativity for synaptophysin (7/7) and chromogranin A (2/2) favored SCA diagnosis. Conclusions: In the case of preoperative workup suspected for Sa-SCA, a “forward acquiring” needle could improve the rate of preoperative histological diagnosis.