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Background: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS., Methods: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat., Clinicaltrials: gov, NCT03100578., Results: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015)., Conclusions: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed., Trial Registration Number: ClinicalTrials.gov, NCT03100578., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Endoscopic vacuum therapy (EVT) is a novel technique for closing upper gastrointestinal (UGI) defects. Available literature includes single-center retrospective cohort studies with small sample sizes. Furthermore, evidence about factors associated with EVT failure is scarce. We aimed to assess the efficacy and safety of EVT for the resolution of UGI defects in a multicenter study and to investigate the factors associated with EVT failure and in-hospital mortality., Methods: This is a prospective cohort study in which consecutive EVT procedures for the treatment of UGI defects from 19 Spanish hospitals were recorded in the national registry between November 2018 and March 2022., Results: We included 102 patients: 89 with anastomotic leaks and 13 with perforations. Closure of the defect was achieved in 84 cases (82%). A total of 6 patients (5.9%) had adverse events related to the EVT. The in-hospital mortality rate was 12.7%. A total of 6 patients (5.9%) died because of EVT failure and 1 case (0.9%) due to a fatal adverse event. Time from diagnosis of the defect to initiation of EVT was the only independent predictor for EVT failure (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05, P = 0.005). EVT failure (OR 24.5, 95% CI 4.5-133, P = 0.001) and development of pneumonia after EVT (OR 246.97, 95% CI 11.15-5,472.58, P = 0.0001) were independent predictors of in-hospital mortality., Discussion: EVT is safe and effective in cases of anastomotic leak and perforations of the upper digestive tract. The early use of EVT improves the efficacy of this technique., (Copyright © 2023 by The American College of Gastroenterology.)

Background: Atypical cellular features are commonly encountered in patients with indeterminate biliary strictures, which are nondiagnostic of malignancy yet cannot rule it out. This study aims to identify clinical features that could discriminate patients with indeterminate biliary strictures and atypical biliary cytology who may harbor underlying malignancy., Methods: All patients with an indeterminate biliary stricture and an atypical brush cytology obtained during endoscopic brushings were identified in a large tertiary-care center. Demographical information, clinical data and the final pathological diagnosis were collected. The study cohort was divided based on the final diagnosis into benign and malignant groups. Descriptive and multivariable analyses were performed., Results: A total of 151 patients were included in the analysis. Of these, 62.9% were males with mean age of 61.7 ± 16.4 years. Overall, there was an almost equal distribution of patients in the benign and malignant groups. Older age (≥65 years), jaundice, weight loss, intrahepatic biliary and pancreatic duct dilation, double-duct sign and presence of a mass were associated with malignancy in the univariate analysis. However, only older age (odds ratio [OR] 1.02, 95% confidence interval [CI] 1.00 to 1.03), jaundice (OR 3.33, 95% CI 1.11 to 9.98) and presence of a mass (OR 12.10, 95% CI 4.94 to 29.67) were significantly associated with malignancy in the multivariate analysis. High CA19-9 was associated with malignancy only in patients with primary sclerosing cholangitis., Conclusion: In patients with indeterminate biliary stricture and atypical brush cytology, older age, jaundice and presence of a mass are significant predictors of malignancy. Patients with such characteristics need prompt evaluation to rule out underlying malignancy., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology.)

Background: The management of ampullary lesions has shifted from surgical approach to endoscopic resection. Previous reports were limited by small numbers of patients and short follow-up. The aim of this study is to describe short- and long-term outcomes in a large cohort of patients undergoing endoscopic ampullectomy., Methods: Retrospective study of endoscopic ampullectomies performed at a tertiary center from January 1999 to October 2016. Information recorded includes patient demographics, clinical outcomes, lesion pathology, procedural events, adverse events and follow-up data., Results: Overall, 103 patients underwent endoscopic resection of ampullary tumours (mean age 62.3 ± 14.3 years, 50.5% female, mean lesion size 20.9 mm; 94.9% adenomas, with a majority of lesions exhibiting low-grade dysplasia (72.7%). Complete endoscopic resection was achieved in 82.5% at initial procedure. Final complete endoscopic resection was achieved in all patients with benign pathology on follow-up procedures. Final pathology showed that 11% had previously undiagnosed invasive carcinoma. Delayed postprocedure bleeding occurred in 21.4%, all of which were managed successfully at endoscopy. Acute pancreatitis complicated 15.5% of procedures (mild in 93.8%). Perforation occurred in 5.8%, all treated conservatively except for one patient requiring surgery. Piecemeal resection was associated with significantly higher recurrence compared to en-bloc resection (54.3% versus 26.2%, respectively, P = 0.012). All recurrences were treated endoscopically., Conclusion: Endoscopic ampullectomy appears both safe and effective in managing patients with ampullary tumours in experienced hands. Most adverse events can be managed conservatively. Many patients develop recurrence during long-term follow-up but can be managed endoscopically. Recurrence rates may be reduced by performing initial en-bloc resection., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology.)

Competing Interests: Competing interests: None declared.

Objectives: Our aim was to identify baseline characteristics associated with disease progression and malignant transformation in low-risk suspected intraductal papillary mucinous neoplasms (IPMNs)., Methods: This is a retrospective cohort study of prospectively maintained databases of pancreatic cysts at 3 international, academic institutions. Five hundred fifty-nine adult patients with clinically suspected asymptomatic IPMN evaluated by radiologic studies or endoscopic ultrasound between 2003 and 2013 without worrisome features and under surveillance for 12 months or longer were included. We evaluated the relationship of baseline demographics and cyst features to disease progression (size increase, development of worrisome features, or high-grade dysplasia/cancer)., Results: After a median of 44 months follow-up, 269 (48%) patients experienced cyst size increase, 68 (12%) developed worrisome features, and 11 (2%) developed high-grade dysplasia/cancer. In multivariable Cox-regression analysis, no baseline characteristics were associated with size increase. An initial cyst size of 2 cm or greater, multifocality, history of prostate cancer, and smoking were the strongest predictors of development of new worrisome features. Univariable analysis found male sex, diabetes, and recent weight loss associated with development of high-grade dysplasia/cancer., Conclusions: Our study demonstrates that low-risk suspected IPMNs carry a small but clinically relevant risk of disease progression and provides data on baseline characteristics that may help in risk stratification.

The real prevalence of pancreatic cystic lesions remains unknown. The malignant potential of some of these lesions remains a cause for significant concern. Thus, it is mandatory to develop a strategy to clearly discriminate those cysts with a potential for malignant transformation from those that do not carry any significant risk. Intraductal papillary mucinous neoplasms and mucinous cystadenomas are mucinous cystic neoplasms with a known malignant potential that have gained greater recognition in recent years. However, despite the numerous studies that have been carried out, their differential diagnosis among other cysts subtypes and their therapeutic approach continue to be a challenge for clinicians. This review contains a critical approach of the current recommendations and management strategies regarding intraductal papillary mucinous neoplasms and mucinous cystadenomas, as well as highlighting the limitations exposed in current guidelines.

Background and Objectives: Pancreatic cysts are evaluated by endoscopic ultrasound and fine needle aspiration (EUS). The only accepted treatment is pancreatectomy, which is associated with morbidity and mortality. This study evaluated the optimal thermal dosimetry of a novel radiofrequency ablation device using a standard electrosurgical unit in ex vivo cyst models., Methods: A modified EUS 22-gauge monopolar needle prototype with a tip electrode connected to a standard electrosurgical unit (Erbe USA, Marietta, GA, USA) was used to induce a subboiling point temperature. A cyst model was created using 2-cm sections of porcine small intestine ligated and filled with saline. After ablation, the cyst models were prepared for pathological evaluation. The epithelial layers were measured in at least two different sites with a micrometer and compared with the corresponding control sample., Results: Thirty-two cyst models were ablated with maximum temperatures of 50°C, 60°C, 90°C, and 97°C in 8, 11, 11, and 2 cysts, respectively. Longer ablation times were required to induce higher temperatures. A trend in the reduction in thickness of the measured layers was observed after exposure to higher temperatures. A temperature over 50°C was required for the ablation of the muscularis, submucosa, and villi, and over 60°C was required to ablate the mucosal crypts., Conclusions: In a preclinical model, a novel radiofrequency EUS-capable needle connected to a standard electrosurgical unit using standard low-voltage coagulation provided ablation in a temperature-dependent fashion with a threshold of at least 60°C and a safe cyst margin below 97°C. This potentially will allow low-cost, convenient cyst ablation.

Objective: The aim of this study was to analyze the outcomes of a long-term intraductal papillary mucinous neoplasm (IPMN) registry and evaluate new guidelines., Methods: A prospectively maintained IPMN registry involving 6 centers in Europe and the United States was used to collect the data. Patients with more than 1-year follow-up and no malignancy diagnosed within the first 3 months of surveillance were included., Results: From 1999 to 2014, 620 patients were included. The median follow-up time was 3 years. Thirty-seven (6%) patients developed malignancy with a median time from IPMN diagnosis to malignancy of 10.3 months. The 1-, 5-, and 10-year actuarial rates of disease-free survival were 97%, 93%, and 92% respectively. Four hundred thirty-one patients met criteria for low-risk branch duct IPMN consisting of cyst size less than 3 cm, with no solid component or main duct dilation. Eight malignancies were diagnosed in this subgroup, all of them within the first 5 years. From this subcohort, 112 patients had a follow-up time of more than 5 years, and no malignancy was diagnosed., Conclusions: In IPMN lesions with low-risk features at baseline, the risk of progression to malignancy after the first 5 years of follow-up was minimal. Furthermore, the main cyst characteristics remained unchanged during their surveillance.

Objective: This study aimed to evaluate Plectin-1 expression as a biomarker of malignant risk for intraductal papillary mucinous neoplasms (IPMNs)., Methods: Plectin-1 immunohistochemistry (IHC) was performed retrospectively on surgical (n = 71) and cytological (n = 33) specimens from Mayo Clinic Jacksonville and UCLA Medical Center, including IPMNs with low-grade dysplasia, high-grade dysplasia (HGD), or an associated invasive adenocarcinoma., Results: Plectin-1 expression was increased in invasive adenocarcinoma compared with adjacent in situ IPMN (P = 0.005), as well as the in situ HGD component of IPMNs with invasive cancer compared with HGD of IPMNs without invasive cancer (P = 0.02). Plectin IHC discriminated IPMNs with invasive adenocarcinoma from noninvasive IPMN (area under the curve [AUC] of 0.79, 75% sensitivity, and 85% specificity) but was insufficient for discriminating HGD IPMN from low-grade dysplasia IPMNs in surgical resections (AUC of 0.67, 56% sensitivity, and 64% specificity) or fine-needle aspiration specimens (AUC of 0.45)., Conclusions: Although Plectin-1 IHC has insufficient accuracy to be used as a definitive biomarker for malignant risk in the evaluation of IPMN biopsy or cytological specimens, increased Plectin-1 expression observed in both invasive cancer and in situ HGD of malignant IPMNs suggests that it might be successfully leveraged as a cyst fluid biomarker or molecular imaging target., Competing Interests: K.A.K. is affiliated with iTi Health, where a plectin targeting peptide imaging agent is licensed. All other authors declare no direct conflict of interest in relation to the present study..

Objectives: The aim of this study was to determine the accuracy of cytology, carcinoembryonic antigen (CEA), and amylase levels in the preoperative diagnosis of intraductal papillary mucinous neoplasms (IPMNs)., Methods: An international registry was started in 2005 and included patients with clinically suspected IPMNs. Those who underwent surgery and had preoperative endoscopic ultrasonography fine-needle aspiration were selected for the study., Results: One hundred eighty patients were included. Cytological analysis for neoplastic cells in IPMNs showed high specificity (87.8%) but low sensitivity (39.4%). The median CEA level was 525.5 ng/mL (n = 78) in IPMNs versus 9.7 ng/mL in nonmucinous cysts (n = 6), showing an area under the receiver operating characteristic curve (AUC) of 0.87. The optimal cutoff CEA value for distinguishing IPMN from nonmucinous cysts was 129 ng/mL. At this level, the sensitivity was 76.9%, and specificity was 83.3%, yielding a positive predictive value of 95.9% and a negative predictive value of 41.9%. Carcinoembryonic antigen was a poor predictor of neoplasia in IPMNs (AUC = 0.55). Amylase did not distinguish IPMNs from mucinous cystadenomas (MCAs) (median, 3759 U/L [n = 28 IPMNs] and 497 U/L [n = 3 MCAs], AUC = 0.65)., Conclusions: Cytology has a limited role because of its lack of sensitivity. Carcinoembryonic antigen modestly differentiated between mucinous and nonmucinous lesions. Amylase did not distinguish IPMNs versus MCAs.

Background & Aims: Increasingly, pancreatic cysts are discovered incidentally in patients undergoing cross-sectional imaging for nonpancreatic reasons. It is unclear whether this increase is caused by improved detection by progressively more sophisticated cross-sectional imaging techniques or by a true increase in prevalence. We aimed to determine the prevalence of incidental pancreatic cysts in patients undergoing magnetic resonance imaging (MRI) for nonpancreatic indications on successive, increasingly sophisticated MRI systems. Also, we compared prevalence based on the demographic characteristics of the patients., Methods: We collected data from MRIs performed at the Mayo Clinic in Florida during the sample months of January and February, from 2005 to 2014. Each patient's clinical chart was reviewed in chronological order to include the first 50 MRIs of each year (500 total). Patients were excluded if they had pancreatic disease including cysts, pancreatic surgery, pancreatic symptoms, pancreatic indication for the imaging study, or previous abdominal MRIs. An expert pancreatic MRI radiologist reviewed each image, looking for incidental pancreatic cysts., Results: Of the 500 patients analyzed, 208 patients (41.6%) were found to have an incidental cyst. A significant relationship was observed between pancreatic cysts and patient age (P < .0001), diabetes mellitus (P = .001), and nonpancreatic cancer (P = .01), specifically nonmelanoma skin cancer (P = .03) or hepatocellular carcinoma (P = .02). The multivariable model showed a strong association between hardware and software versions and detection of cysts (P < .0001); the old hardware detected pancreatic cysts in 30.3% of patients, whereas the newest hardware detected cysts in 56.3% of patients., Conclusions: Based on an analysis of data collected from 2005 through 2014, newer versions of MRI hardware and software corresponded with higher numbers of pancreatic cysts detected. Older age, diabetes, and the presence of nonpancreatic cancer (specifically nonmelanoma skin cancer and hepatocarcinoma) were also associated with the presence of cysts., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Intraductal papillary mucinous neoplasms of the pancreas are increasingly diagnosed. Due to their malignant potential, greater understanding of their nature is required., Aims: Define risk factors for malignancy in intraductal papillary mucinous neoplasms., Methods: An international, multicentre study was performed in Europe and the United States. Clinical databases were reviewed for patients with intraductal papillary mucinous neoplasms diagnosis., Results: Of 1126 patients, 84 were diagnosed with invasive carcinoma/high-grade dysplasia and were compared to the rest of the cohort. Multivariate logistic analysis showed a statistically significant association between cancer/high-grade dysplasia and the variables smoking history (OR 1.9, 95% CI [1.1-3.1]), body mass index (OR 1.1, 95% CI [1-1.1]), symptoms (OR 3.4, 95% CI [1.9-6]), jaundice (OR 0.1, 95% CI [0-0.3]), and steatorrhea (OR 0.3, 95% CI [0.1-0.8]). Univariate analysis showed no association between malignancy and the cyst number/location (p=0.3 and p=0.5, respectively) although a strong association was shown for cyst size (p<0.001). The presence and size of nodules (p<0.01) and main duct involvement (p<0.001) were also strongly related with malignancy., Conclusion: The presence of jaundice and steatorrhea, smoking, high body mass index, and imaging features such as cyst size, main duct involvement, and the presence and size of mural nodules are associated with high-grade neoplasia in intraductal papillary mucinous neoplasms., (Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Solid organ transplant recipients have an increased risk of cancer due to immunosuppressive therapy. Pancreatic cystic lesions are increasingly being detected, some with malignant potential. We aimed to determine the prevalence of these lesions and describe their clinical course in these patients., Methods: We identified the presence of pancreatic cystic lesions in a retrospective cohort of 3188 consecutive solid organ transplant recipients from 2000 to 2013 and compared lesion characteristics at initial and follow-up imaging, when available., Results: Lesion prevalence was 11.4% (365/3188), and increased with age. Median diameter of the largest lesions was 7mm (range: 1-31mm). We noted worrisome features in two patients (0.54%) at the time of cyst diagnosis. Of 155 patients who underwent follow-up imaging, the cysts size remained stable in 80%, increased in 16%, and decreased in 4%. Two patients (1.3%) developed features concerning for cancer. One underwent pancreatic surgery, and pathology confirmed the presence of high-grade dysplasia. The other continued with conservative management due to multiple comorbidities., Conclusions: Pancreatic cystic lesions are common in solid organ transplant recipients. In lesions without high-risk features, the development of features worrisome for cancer is rare. These lesions can be managed conservatively, and their presence should not affect transplant eligibility., (Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)