Probiotic mixture in patients after Helicobacter pylori eradication: a real-life experience.

BACKGROUND: Eradication for Helicobacter pylori usually induces digestive dysbiosis that, in turn, elicits symptoms. Consequently, probiotic supplementation may counterbalance the disturbed microbiota after this procedure. So, probiotics may restore microbiota homeostasis quickly relieve complaints. METHODS: The current study evaluated the efficacy and safety of Abivisor®, a food supplement containing Lacticaseibacillus rhamnosus LR06 (3 billion living cells), Lactiplantibacillus pentosus LPS01(100 million living cells), Lactiplantibacillus plantarum LP01 (1 billion living cells), and N-acetyl cysteine (60 mg). Patients were randomized into two groups (2:1). Group A took one stick/daily for 60 days after eradication. Group B was considered as control. Patients were evaluated at baseline (T0) and after 15 (T1), 30 (T2), and 60 (T3) days. The severity of digestive symptoms was measured by patients using a Visual Analog Scale. The percentage of patients with each symptom was also evaluated. RESULTS: Abivisor® has significantly and progressively diminished intestinal symptoms' presence and severity at T1, T2, and even more at T3. Accordingly, the percentage of symptomatic patients diminished more rapidly and significantly in group A than in B. All patients well tolerated the food supplement. CONCLUSIONS: The present study suggests that Abivisor® may be an effective and safe therapeutic option for managing patients undergoing H. pylori eradication.

Outcomes predictors in endoscopic ultrasound-guided choledochoduodenostomy with lumen-apposing metal stent: Systematic review and meta-analysis.

Background and study aims EUS-guided choledochoduodenostomy (EUS-CDS) is a minimally invasive procedure used to treat malignant biliary obstruction (MBO) by transduodenal placement of a lumen-apposing metal stent (LAMS) into the extrahepatic bile duct. To identify factors that contribute to safe and effective EUS-CDS using LAMS, we performed a systematic review of the literature and meta-analysis. Methods The methodology of our analysis was based on PRISMA recommendations. Electronic databases (Medline, Scopus, EMBASE) were searched up to November 2022. Full articles that included patients with distal malignant biliary obstruction who underwent EUS-CDS using LAMS after failed endoscopic retrograde cholangiopancreatography were eligible. Random-effect meta-analysis was performed reporting pooled rates of technical success, clinical success, and adverse events (AEs) by means of a random model. Multivariate meta-regression and subgroup analysis were performed to assess possible associations between the outcomes and selected variables to assess the correlation between outcomes and different variables. Results were also stratified according to stent size. Results Twelve studies with 845 patients were included in the meta-analysis. Pooled technical and clinical success rates were 96% (95% confidence interval [CI] 94%-98%; I 2 = 52.29%) and 96% (95%CI 95%-98%), respectively, with no significant association with baseline characteristics, such are sex, age, common bile duct diameter, or stent size. The pooled AE rate was 12% (95%CI: 8%-16%; I 2 = 71.62%). The AE rate was significantly lower when using an 8 × 8 mm stent as compared with a 6 × 8 mm LAMS (odds ratio 0.59, 0.35-0.99; P = 0.04), with no evidence of heterogeneity (I 2 = 0%). Conclusions EUS-CDS with LAMS is a safe and effective option for relief of MBO. Selecting an appropriate stent size is crucial for achieving optimal safety outcomes.

Italian Survey on Endoscopic Biliary Drainage Approach in Patients with Surgically Altered Anatomy.

Background and Objectives: Biliary drainage (BD) in patients with surgically altered anatomy (SAA) could be obtained endoscopically with different techniques or with a percutaneous approach. Every endoscopic technique could be challenging and not clearly superior over another. The aim of this survey is to explore which is the standard BD approach in patients with SAA. Materials and Methods: A 34-question online survey was sent to different Italian tertiary and non-tertiary endoscopic centers performing interventional biliopancreatic endoscopy. The core of the survey was focused on the first-line and alternative BD approaches to SAA patients with benign or malignant obstruction. Results: Out of 70 centers, 39 answered the survey (response rate: 56%). Only 48.7% of them declared themselves to be reference centers for endoscopic BD in SAA. The total number of procedures performed per year is usually low, especially in non-tertiary centers; however, they have a low tendency to refer to more experienced centers. In the case of Billroth-II reconstruction, the majority of centers declared that they use a duodenoscope or forward-viewing scope in both benign and malignant diseases as a first approach. However, in the case of failure, the BD approach becomes extremely heterogeneous among centers without any technique prevailing over the others. Interestingly, in the case of Roux-en-Y, a significant proportion of centers declared that they choose the percutaneous approach in both benign (35.1%) and malignant obstruction (32.4%) as a first option. In the case of a previous failed attempt at BD in Roux-en-Y, the subsequent most used approach is the EUS-guided intervention in both benign and malignant indications. Conclusions: This survey shows that the endoscopic BD approach is extremely heterogeneous, especially in patients with Roux-en-Y reconstruction or after ERCP failure in Billroth-II reconstruction. Percutaneous BD is still taken into account by a significant proportion of centers in the case of Roux-en-Y anatomy. The total number of endoscopic BD procedures performed in non-tertiary centers is usually low, but this result does not correspond to an adequate rate of referral to more experienced centers.

Efficacy and safety of endoscopic ultrasound-guided hepatico-gastrostomy: a meta-regression analysis.

BACKGROUND AND STUDY AIM: EUS-guided hepaticogastrostomy (EUS-HGS) is a valid option for EUS-guided biliary drainage that has been increasingly used in the last decade. The aims of the study were to provide a systematic review with meta-analysis and meta-regression of features and outcomes of this procedure. METHODS: MEDLINE, Scopus, Web-of-Science, and Cochrane databases were searched for literature pertinent to EUS-HGS. Meta-analysis of proportions and meta-regression of potential modifiers of the main outcome measures were applied. The main outcome was technical success. Secondary outcomes were clinical success and procedure-related adverse events (AEs). RESULTS: Thirty-three studies including 1644 patients were included in the meta-analysis. Malignant biliary obstruction was the underlying cause in almost all (99.6%) cases; the main indications for EUS-HGS were duodenal/papillary invasion (34.8%), surgical altered anatomy (18.4%) and hilar stenosis (16%). Pooled technical success of EUS-HGS was 97.7% (95%-CI: 96.1-99%, I2=0%), the intention to treat (ITT) clinical success was 88.1% (95%-CI: 84.7-91.2%, I2=33.9%) and procedure-related AEs occurred in 12% (95%-CI: 9.8-14.5%, I2=20.4%), being cholangitis/sepsis (2.8%) and bleeding (2.3%) the most frequent. The rate of procedure related AEs was reduced with the use of dedicated stents at the univariable meta regression analysis. Meta-regression showed that technical success and clinical success rates were modified by centers' experience (>4/year). CONCLUSIONS: EUS-HGS represents an effective and safe procedure for EUS-guided biliary drainage in patients with malignant biliary obstruction. Future studies should address the impact of center experience, patient selection, and use of dedicated stents to improve this technique's performance.

Endoscopic Ultrasound-Guided Drainage of Pancreatic Fluid Collections: Not All Queries Are Already Solved.

Pancreatic fluid collections (PFCs) are well-known complications of acute pancreatitis. The overinfection of these collections leads to a worsening of the prognosis with an increase in the morbidity and mortality rate. The primary strategy for managing infected pancreatic necrosis (IPN) or symptomatic PFCs is a minimally invasive step-up approach, with endosonography-guided (EUS-guided) transmural drainage and debridement as the preferred and less invasive method. Different stents are available to drain PFCs: self-expandable metal stents (SEMSs), double pigtail stents (DPPSs), or lumen-apposing metal stents (LAMSs). In particular, LAMSs are useful when direct endoscopic necrosectomy is needed, as they allow easy access to the necrotic cavity; however, the rate of adverse events is not negligible, and to date, the superiority over DPPSs is still debated. Moreover, the timing for necrosectomy, the drainage technique, and the concurrent medical management are still debated. In this review, we focus attention on indications, timing, techniques, complications, and particularly on aspects that remain under debate concerning the EUS-guided drainage of PFCs.

EUS-Guided Gallbladder Drainage Using a Lumen-Apposing Metal Stent for Acute Cholecystitis: Results of a Nationwide Study with Long-Term Follow-Up.

BACKGROUND: Although endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has become one of the treatments of choice for acute cholecystitis (AC) in fragile patients, scant data are available on real-life settings and long-term outcomes. METHODS: We performed a multicenter retrospective study including EUS-guided GBD using LAMS for AC in 19 Italian centers from June 2014 to July 2020. The primary outcomes were technical and clinical success, and the secondary outcomes were the rate of adverse events (AE) and long-term follow-up. RESULTS: In total, 116 patients (48.3% female) were included, with a mean age of 82.7 ± 11 years. LAMS were placed, transgastric in 44.8% of cases, transduodenal in 53.3% and transjejunal in 1.7%, in patients with altered anatomy. Technical success was achieved in 94% and clinical success in 87.1% of cases. The mean follow-up was 309 days. AEs occurred in 12/116 pts (10.3%); 8/12 were intraprocedural, while 1 was classified as early (<15 days) and 3 as delayed (>15 days). According to the ASGE lexicon, two (16.7%) were mild, three (25%) were moderate, and seven (58.3%) were severe. No fatal AEs occurred. In subgroup analysis of 40 patients with a follow-up longer than one year, no recurrence of AC was observed. CONCLUSIONS: EUS-GBD had high technical and clinical success rates, despite the non-negligible rate of AEs, thus representing an effective treatment option for fragile patients.

The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Endoscopic ultrasound-guided drainage of pancreatic collections with dedicated metal stents: A nationwide, multicenter, propensity score-matched comparison.

BACKGROUND: The new dedicated stents for endoscopic ultrasound (EUS)-guided transluminal drainage of peri­pancreatic fluid collections (PFCs) demonstrated optimal efficacy and safety profiles. AIMS: This study aimed to evaluate the safety, technical and clinical success, and recurrence rate of PFCs drained with Lumen Apposing Metal Stent (LAMS) or Bi-Flanged Metal Stent (BFMS). METHODS: Data from a multicenter series of PFCs treated with LAMS or BFMS at 30 Italian centers during a 5-year period were retrieved. The rate of adverse events (AEs), technical success, clinical success, PFC recurrence were evaluated. To overcome biases, a 1-to-1 match was created using propensity score analysis. RESULTS: Out of 476 patients, 386 were treated with LAMS and 90 with BFMS, with a median follow-up of 290 days (95% CI 244 to 361). Using propensity score matching, 84 patients were assigned to each group. The incidence of AEs did not differ between the two stents (13.1% versus 15.5%, p = 0.29), mainly bleeding or recurrence rate (4.7% versus 3.5%, p = 1). Technical and clinical success in the BFMS and LAMS groups were 92% versus 95% (p = 0.36) and 91% versus 94% (p = 0.64), respectively. CONCLUSION: Our study demonstrates that LAMS and BFMS have comparable safety profiles with similar technical and clinical success rates for EUS-guided PFC drainage.

Fully covered versus partially covered self-expandable metal stents for palliation of distal malignant biliary obstruction: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are standardly used for distal malignant biliary obstruction (dMBO). Although data suggest that covered versus uncovered SEMSs increase the time to recurrent biliary obstruction (TRBO), no data are available for fully covered (FC) versus partially covered (PC) designs. METHODS: PubMed, Scopus, and Cochrane databases were screened up to January 2023 for studies concerning dMBO treated by an FC- or PC-SEMS and describing adverse events (AEs), recurrences, or TRBO for specific design subpopulations. Pooled proportions or means were calculated using a random-effects model. Several subanalyses were preplanned, including a subanalysis restricted to prospective studies and unresectable diseases. Heterogeneity and publication bias were explored. Standardized differences (d-values) were calculated between groups. RESULTS: From 1290 records, 62 studies (3327 using FC-SEMSs and 2322 using PC-SEMSs) were included. FC- versus PC-SEMSs showed negligible differences in the rate of total AEs (12% vs 9.9%) and all specific AEs, including cholecystitis (2.5% vs 2.6%). In a subanalysis restricted to prospective studies and unresectable diseases, the rate of RBO was comparable between FC-SEMSs (27.3% [95% confidence interval {CI}, 23.7-31.2], I2 = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I2 = 85.09%), despite small differences (d-values between .186 and .216) in the rate of ingrowth (.5% vs 2.9%) favoring FC-SEMSs and migration (9.8% vs 4.3%) favoring PC-SEMSs. TRBO was shorter for FC-SEMSs (238 days [95% CI, 191-286], I2 = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I2 = 71.9%; d-value = .116). CONCLUSIONS: Despite considerable heterogeneity and small standardized differences, PC-SEMSs consistently exhibited longer TRBO than FC-SEMSs across analyses, without any other differences in AE rates, potentially proposing PC-SEMSs as the standard comparator and TRBO as the primary outcome for future randomized studies on dMBO. (Clinical trial registration number: CRD42023393965.).

Metal stent and percutaneous endoscopic necrosectomy as dual approach for the management of complex walled-off pancreatic necrosis.

Pancreatic fluid collections (PFCs) are one of the local complications of acute pancreatitis and include walled-off pancreatic necrosis (WOPN), which are complex entities with challenging management. The infection of pancreatic necrosis leads to a poorer prognosis, with a growth of the mortality rate up to 30%. The primary strategy for managing PFCs is a minimally invasive step-up approach, with endosonography-guided transmural drainage and debridement as the preferred and less invasive method. Percutaneous drainage (PCD) can be the technique of choice when endoscopic drainage is not feasible, for example for early PFCs without a mature wall or for the anatomic location and extension to the paracolic gutter of the collection. As PCD alone may be ineffective, especially when a great amount of necrosis is present, a percutaneous endoscopic necrosectomy (PEN) has been proposed, showing interesting results. The technique consists of the placement of an esophageal fully or partially covered self-expandable metal stent (SEMS) percutaneously into the collection and a direct debridement can be performed using a flexible endoscope through the SEMS. In this review, we will discuss about the role of metal stent and PEN for the management of complex walled-off pancreatic necrosis.

The Role of Endoscopy in the Palliation of Pancreatico-Biliary Cancers: Biliary Drainage, Management of Gastrointestinal Obstruction, and Role in Relief of Oncologic Pain.

Therapeutic endoscopy permits many and various treatments for cancer palliation in patients with bilio-pancreatic cancers, enabling different options, supporting patients during their route to oncologic treatments, and trying to improve their quality of life. Therefore, both endoscopic and endoscopic ultrasound (EUS)-guided techniques are performed in this scenario. We performed a literature review focusing on the role of endoscopy in the palliation of those advanced pancreatic and biliary cancers developing malignant biliary obstruction (MBO), gastric outlet obstruction (GOO), and pain unresponsive to medical therapies. Therefore, we explored and focused on the clinical outcomes of endoscopic procedures in this scenario. In fact, the endoscopic treatment is based on achieving biliary drainage in the case of MBO through endoscopic retrograde cholangiopancreatography (ERCP) or EUS-guided biliary drainage (EUS-BD), while GOO is endoscopically treated through the deployment of an enteral stent or the creation of EUS-guided gastro-entero-anastomosis (EUS-GEA). Furthermore, untreatable chronic abdominal pain is a major issue in patients unresponsive to high doses of painkillers, so EUS-guided celiac plexus neurolysis (CPN) or celiac ganglia neurolysis (CGN) helps to reduce dosage and have better pain control. Therefore, therapeutic endoscopy in the palliative setting is an effective and safe approach for managing most of the clinical manifestations of advanced biliopancreatic tumors.

Endoscopic Management of Bleeding in Altered Anatomy after Upper Gastrointestinal Surgery.

Postoperative non variceal upper gastrointestinal haemorrhage may occur early or late and affect a variable percentage of patients-up to about 2%. Most cases of intraluminal bleeding are an indication for urgent Esophagogastroduodenoscopy (EGD) and require endoscopic haemostatic treatment. In addition to the approach usually adopted in non-variceal upper haemorrhages, these cases may be burdened with difficulties in terms of anastomotic tissue, angled positions, and the risk of further complications. There is also extreme variability related to the type of surgery performed, in the context of oncological disease or bariatric surgery. At the same time, the world of haemostatic devices available in digestive endoscopy is increasing, meeting high efficacy rates and attempting to treat even the most complex cases. Our narrative review summarises the current evidence in terms of different approaches to endoscopic haemostasis in upper bleeding in altered anatomy after surgery, proposing an up-to-date guidance for endoscopic clinicians and at the same time, highlighting areas of future scientific research.

Outcomes of a 3-year prospective surveillance in individuals at high-risk for pancreatic cancer.

INTRODUCTION: Pancreatic cancer (PC) surveillance of high-risk individuals (HRI) is becoming more common worldwide, aiming at anticipating PC diagnosis at a pre-clinical stage. In 2015 the Italian Registry of Families at Risk of Pancreatic Cancer (IRFARPC) was created. We aimed to assess the prevalence and incidence of pancreatic findings, oncological outcomes, and harms seven years after the Italian Registry of Families at Risk of Pancreatic Cancer (IRFARPC) inception focusing on individuals with at least a 3-year follow-up or developing events before. METHODS: HRI (subjects with family history or mutation carriers with/without family history were enrolled in 18 Centers. They underwent annual magnetic resonance with cholangiopancreatography or endoscopic ultrasound (NCT04095195). RESULTS: During the study period (June 2015 - September 2022), 679 individuals were enrolled. Of these, 524 (77.2%) underwent at least baseline imaging, and 156 (29.8%) with at least a 3-year follow-up or pancreatic malignancy/pre-malignancy-related events, and represented the study population. Median age was 51 (IQR 16). Familial PC cases (FPC) accounted for 81.4% of HRI, and individuals with pathogenic variant (PV) for 18.6%. Malignant (n=8) and pre-malignant (1 PanIN3) lesions were found in nine individuals. Five of these 8 cases occurred in PV carriers, four in FPC cases (two tested negative at germline testing, and two others were not tested). Three of the 8 PC were Stage I. Five of the 8 PC were resectable, 3 Stage I, all advanced cases being prevalent. The 1-, 2-, and 3-year cumulative hazard of PC was 1.7%, 2.5% and 3%, respectively. Median overall and disease-free survival of resected PC patients were 18 and 12 months (95%CI not computable). Considering HRI who underwent baseline imaging, six pancreatic neuroendocrine neoplasms (one resected) and one low-yield surgery (low-grade mixed-IPMN) were also reported. CONCLUSION: PC surveillance in a fully public healthcare system is feasible, safe, and leads to early PC or pre-malignant lesions diagnoses, mostly at baseline but also over time.

PERcutaneous transhepatic CHOLangioscopy using a new single-operator short cholangioscope (PERCHOL): European feasibility study.

OBJECTIVES: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs). METHODS: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated. RESULTS: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months. CONCLUSION: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis.

Repeated endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions after previous nondiagnostic or inconclusive sampling.

OBJECTIVES: Repeated endoscopic ultrasound (EUS)-guided tissue acquisition represents the standard practice for solid pancreatic lesions after previous nondiagnostic or inconclusive results. Since data are lacking, we aimed to evaluate the diagnostic performance of repeated EUS fine-needle biopsy (rEUS-FNB) in this setting. The primary outcome was diagnostic accuracy; sample adequacy, sensitivity, specificity, and safety were secondary outcomes. METHODS: Consecutive patients undergoing rEUS-FNB for solid pancreatic lesions at 23 Italian centers from 2019 to 2021 were retrieved. Pathology on the surgical specimen, malignant histology together with ≥6-month follow-up, and benign pathology together with ≥12-month follow-up were adopted as gold standards. RESULTS: Among 462 patients, 56.5% were male, with a median age of 68 (59-75) years, malignancy prevalence 77.0%. Tumor size was 26 (20-35) mm. Second-generation FNB needles were used in 89.6% cases. Diagnostic accuracy, sensitivity, and specificity of rEUS-FNB were 89.2%, 91.4%, and 81.7%, respectively (19 false-negative and 12 false-positive results). On multivariate analysis, rEUS-FNB performed at high-volume centers (odds ratio [OR] 2.12; 95% confidence interval [CI] 1.10-3.17; P = 0.03) and tumor size (OR 1.03; 95% CI 1.00-1.06; P = 0.05) were independently related to diagnostic accuracy. Sample adequacy was 94.2%. Use of second-generation FNB needles (OR 5.42; 95% CI 2.30-12.77; P < 0.001) and tumor size >23 mm (OR 3.04; 95% CI 1.31-7.06; P = 0.009) were independently related to sample adequacy. CONCLUSION: Repeated EUS-FNB allowed optimal diagnostic performance after nondiagnostic or inconclusive results. Patients' referral to high-volume centers improved diagnostic accuracy. The use of second-generation FNB needles significantly improved sample adequacy over standard EUS-FNB needles.

European' health care indicators and pancreatic cancer incidence and mortality: A mediation analysis of Eurostat data and Global Burden of Disease Study 2019.

AIM: To highlight correlations existing between incidence and mortality of pancreatic cancer, and health care indicators in 36 European countries. METHODS: The Global Burden of Disease (GBD) and Eurostat databases were queried between 2004 and 2019. Incidence and mortality were age-standardized. From Eurostat, indicators regarding expenditure, hospital beds, medical technology, health personnel, physicians by medical specialty and unmet needs for medical examination were extracted. Correlations between GBD and Eurostat data were analysed through mediation analysis applying clustering for countries. RESULTS: Incidence increased by +0.6% per year (p = 0.001) and mortality by +0.3% (p = 0.001), being increasing for most of the European countries considered. Incidence and mortality were strongly positively correlated (p = 0.001). Higher current health expenditure, expenditure in inpatient curative care, the number of available beds, the number of computed tomography scan, magnetic resonance units, practising medical doctors were all related to higher incidence (p < 0.05), whereas the unmet need for medical examinations was related to lower incidence. When the mediator' effect of incidence was handled, these indicators, together with expenditure on outpatient curative cares, the number of pet scanners and of radiation therapy equipment, were related to lower mortality (p < 0.05). CONCLUSIONS: Health care environment correlates with reported incidence and mortality of pancreatic cancer. This highlights both that ameliorated socio-economic societies suffer from higher incidence but lower mortality, as well as the epidemiological bias originating from countries' diagnostic ability.

EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMSs) has been reported as a rescue treatment with encouraging results for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) and after failure of both ERCP and EUS-guided choledochoduodenostomy. METHODS: This was a multicenter retrospective analysis of all cases of consecutive EUS-GBD with LAMSs used as a rescue treatment for patients with DMBO in 14 Italian centers from June 2015 to June 2020. Primary endpoints were technical and clinical success, whereas the secondary endpoint was the adverse event (AE) rate. RESULTS: Forty-eight patients (52.1% women) with a mean age of 74.3 ± 11.7 years were included in the study. Biliary stricture was related to pancreatic adenocarcinoma (85.4%), duodenal adenocarcinoma (2.1%), cholangiocarcinoma (4.2%), ampullary cancer (2.1%), colon cancer (4.2%), and metastatic breast cancer (2.1%). The mean diameter of the common bile duct was 13.3 ± 2.8 mm. LAMSs were placed transgastrically in 58.3% of cases and transduodenally in 41.7%. Technical success was 100%, whereas clinical success was 81.3%, with a mean total bilirubin reduction after 2 weeks of 66.5%. The mean procedure time was 26.4 minutes, and the mean hospital stay was 9.2 ± 8.2 days. AEs occurred in 5 patients (10.4%): 3 were classified as intraprocedural and 2 were classified as delayed because they occurred after >15 days. When the American Society for Gastrointestinal Endoscopy lexicon was used, 2 AEs were mild and 3 were moderate (2 buried LAMSs). The mean follow-up was 122 days. CONCLUSIONS: Our study shows that EUS-GBD with LAMSs used as a rescue treatment for patients affected by DMBO represents a valuable option in terms of technical and clinical success rates, with an acceptable AE rate. To the best of our knowledge, this is the largest study concerning the use of this procedure. (Clinical trial registration number: NCT03903523.).

Usefulness of Contrast-Enhanced Endoscopic Ultrasound (CH-EUS) to Guide the Treatment Choice in Superficial Rectal Lesions: A Case Series.

INTRODUCTION: Large rectal lesions can conceal submucosal invasion and cancer nodules. Despite the increasing diffusion of high-definition endoscopes and the importance of an accurate morphological evaluation, a complete assessment in this setting can be challenging. Endoscopic ultrasound (EUS) plays an established role in the locoregional staging of rectal cancer, although this technique has a tendency toward the over-estimation of the loco-regional (T) staging. However, there are still few data on contrast-enhanced endoscopic ultrasound (CH-EUS), especially if this ancillary technique may increase the accuracy for predicting invasive nodules among large rectal lesions. MATERIAL AND METHODS: Consecutive large (≥20 mm) superficial rectal lesions with high-definition endoscopy, characterized by focal areas suggestive for invasive cancer/2B type according to JNET classification, were considered for additional standardized evaluation via CH-EUS with Sonovue ©. RESULTS: From 2020 to 2023, we evaluated 12 consecutive superficial rectal lesions with sizes ranging from 20 to 180 mm. This evaluation provided additional elements to support the therapeutic decision made. Lesions were treated with surgical (3/12) or endoscopic treatment (9/12) according to their morphology and CH-EUS evaluation. CONCLUSION: Contrast-enhanced endoscopic ultrasound can provide an additional evaluation for large and difficult-to-classify rectal lesions. In our experience, CH-EUS staging corresponded to the final pathological stages in 9/12 (75%) lesions, improving the distinction between T1 and T2 lesions. Larger prospective studies and randomized trials should be conducted to support and standardize this approach.

Direct Endoscopic Necrosectomy of a Recurrent Walled-Off Pancreatic Necrosis at High Risk for Severe Bleeding: A Hybrid Technique Using a Dedicated Device.

Direct endoscopic necrosectomy (DEN) is a challenging procedure for the debridement of walled-off pancreatic necrosis (WOPN), which may be complicated by several adverse events, primarily bleeding which may require radiological embolization or even surgery. The lack of dedicated devices for this purpose largely affects the possibility of safely performing DEN which increases the risk of complications. We present the case of a 63 years-old man who underwent an endoscopic ultrasound (EUS)-guided drainage of a WOPN, and who was readmitted one month after stent removal with clinical, endoscopic, and radiological signs of infected necrosis involving the splenic artery. A second EUS-guided drainage was performed, with clear visualization of the arterial vessel in the midst of a large amount of solid necrosis. Due to the high risk of major bleeding during DEN, a hybrid procedure in the angiographic room was performed, in order to identify and avoid, under fluoroscopic control, the splenic artery during the entire procedure guide, which was successfully performed using the EndoRotor system. We hereby review the current literature regarding DEN using the EndoRotor system. The case reported, with a literature overview, may help the management of these patients affected by benign but life-threatening conditions which involve a multidisciplinary setting.