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Background: Predicting Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis (PEP) risk can be determinant in reducing its incidence and managing patients appropriately, however studies conducted thus far have identified single-risk factors with standard statistical approaches and limited accuracy. Aim: To build and evaluate performances of machine learning (ML) models to predict PEP probability and identify relevant features. Methods: A proof-of-concept study was performed on ML application on an international, multicenter, prospective cohort of ERCP patients. Data were split in training and test set, models used were gradient boosting (GB) and logistic regression (LR). A 10-split random cross-validation (CV) was applied on the training set to optimize parameters to obtain the best mean Area Under Curve (AUC). The model was re-trained on the whole training set with the best parameters and applied on test set. Shapley-Additive-exPlanation (SHAP) approach was applied to break down the model and clarify features impact. Results: One thousand one hundred and fifty patients were included, 6.1% developed PEP. GB model outperformed LR with AUC in CV of 0.7 vs 0.585 (p-value=0.012). GB AUC in test was 0.671. Most relevant features for PEP prediction were: bilirubin, age, body mass index, procedure time, previous sphincterotomy, alcohol units/day, cannulation attempts, gender, gallstones, use of Ringer's solution and periprocedural NSAIDs. Conclusion: In PEP prediction, GB significantly outperformed LR model and identified new clinical features relevant for the risk, most being pre-procedural.

Background The European Society of Gastrointestinal Endoscopy recommends rectal indomethacin or diclofenac before endoscopic retrograde cholangiopancreatography (ERCP) to prevent post-ERCP pancreatitis. However, data on the prophylactic effect in patients with primary sclerosing cholangitis (PSC) are lacking. Methods This was a retrospective case-control study. In 2009-2018, a total of 2000 ERCPs were performed in 931 patients with PSC. Case procedures (N = 1000 after November 2013) were performed after administration of rectal diclofenac. Control procedures (N = 1000 before November 2013) were performed with the same indication but without diclofenac. Acute post-ERCP pancreatitis and other ERCP-related adverse events (AEs) were evaluated. Results Post-ERCP pancreatitis developed in 49 (4.9%) procedures in the diclofenac group and 62 (6.2%) procedures in the control group (p = 0.241). No difference existed between the groups in terms of the severity of pancreatitis or any other acute AEs. The risk of pancreatitis was elevated in patients with native papilla: 11.4% in the diclofenac group and 8.7% in the control group (p = 0.294). In adjusted logistic regression, diclofenac did not reduce the risk of pancreatitis (odds ratio (OR) = 1.074, 95% confidence interval 0.708-1.629, p = 0.737). However, in generalised estimation equations with the advanced model, diclofenac seemed to diminish the risk of pancreatitis (OR = 0.503) but not significantly (p = 0.110). Conclusion In this large patient cohort in a low-risk unit, diclofenac does not seem to reduce the risk of post-ERCP pancreatitis in patients with PSC. The trend in the pancreatitis rate after ERCP is decreasing. The evaluation of the benefits of diclofenac among PSC patients warrants a randomised controlled study targeted to high-risk patients and procedures.

Background Difficult biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) increases the risk of post-ERCP pancreatitis (PEP). The purpose of this prospective, randomized, multicenter study was to compare two advanced rescue methods, transpancreatic biliary sphincterotomy (TPBS) and a double-guidewire (DGW) technique, in difficult common bile duct (CBD) cannulation. Methods Patients with native papilla and planned CBD cannulation were recruited at eight Scandinavian hospitals. An experienced endoscopist attempted CBD cannulation with wire-guided cannulation. If the procedure fulfilled the definition of difficult cannulation and a guidewire entered the pancreatic duct, randomization to either TPBS or to DGW was performed. If the randomized method failed, any method available was performed. The primary end point was the frequency of PEP and the secondary end points included successful cannulation with the randomized method. Results In total, 1190 patients were recruited and 203 (17.1 %) were randomized according to the study protocol (TPBS 104 and DGW 99). PEP developed in 14/104 patients (13.5 %) in the TPBS group and 16/99 patients (16.2 %) in the DGW group (P = 0.69). No difference existed in PEP severity between the groups. The rate of successful deep biliary cannulation was significantly higher with TPBS (84.6 % [88/104]) than with DGW (69.7 % [69/99]; P = 0.01). Conclusions In difficult biliary cannulation, there was no difference in PEP rate between TPBS and DGW techniques. TPBS is a good alternative in cases of difficult cannulation when the guidewire is in the pancreatic duct.

In European Society of Gastrointestinal Endoscopy guidelines, biliary cannulation of native papilla is defined as difficult in the presence of5 papilla contacts,5 min cannulation time or1 unintended pancreatic duct cannulation (5-5-2). The aim is to test 5-5-2-criteria in a single-center practice predicting the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), and to study the efficacy of transpancreatic biliary sphincterotomy (TPBS) as an advanced method for biliary cannulation.Prospectively collected data of 821 patients with native papilla were analyzed. Primary cannulation was the first method chosen for cannulation (sphincterotome and a guidewire). Advanced cannulation method was endoscopist-chosen cannulation method after failed primary cannulation.Primary cannulation succeeded in 599 (73%) patients in a median of 2 min. TPBS ± needle knife resulted in a 90% success rate. The final cannulation success was 814 (99.1%) cases in a median of 5.3 min. PEP risk was 4.0%. When primary cannulation succeeded, the PEP rate was 2.3%. When advanced methods were needed, the PEP rate increased to 13.5%. Altogether 311 (37.9%) patients fulfilled at least one 5-5-2-criterion. In patients without 5-5-2-criteria, the primary cannulation succeeded in 79.6% (n = 477), compared to 20.4% (n = 122) with the criteria, P0.001, indicating the need to exchange the cannulation method instead of persistence. If all the 5-5-2-criteria were present, the risk of PEP was 12.7%.The results support the use of the 5-5-2-criteria for difficult cannulation. TPBS is an effective advanced cannulation method with an acceptable complication rate.

Introduction: Risk of post-ERC pancreatitis (PEP) in patients with primary sclerosing cholangitis (PSC) is 1-7.8%. PSC is often associated with inflammatory bowel disease and autoimmune hepatitis, which are usually treated with thiopurines. The role of thiopurines in PEP risk is still unclear. Aims and methods: We evaluated the thiopurine use in PEP. The data of 354 PSC patients who underwent 985 ERCs between 2009 and 2018 were collected. 177 patients treated with thiopurines (study group, SG) and 177 controls (CG) were matched with a propensity score (PSM). Odds ratios (ORs) with 95% confidence interval (95% CI) were calculated. Multivariable logistic regression analysis and generalized linear mixed model were performed. The P-value < 0.05 was significant. Results: In matched data, 472 ERCs were performed in SG and 513 in CG. Thiopurines were used in 373/472 (79.0%) ERCs in SG. The PEP rate was 5.3% in SG and 5.7% in CG ( p = 0.889). Unintentional pancreatic duct cannulation (OR 1.28, 95%CI 1.07-1.51, p = 0.004), and periampullary diverticulum (OR 4.87, 95%CI 1.72-11.98, p = 0.001) increased the risk of PEP. Conclusion: Prior or present thiopurine use did not increase the risk of PEP. (c) 2021 The Author(s). Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )

Background Transpancreatic biliary sphincterotomy (TPBS) is an advanced cannulation method for accessing common bile duct (CBD) in endoscopic retrograde cholangiopancreatography (ERCP). If CBD cannulation is difficult, an endoscopist can open the septum between the pancreatic and biliary duct with a sphincterotome to gain access. Long-term results of this procedure are unclear. We wanted to evaluate the short- and long-term complications of TPBS on patients with native papilla and benign indication for ERCP. Patients and Methods ERCPs performed in Helsinki University Hospital between 2007 and 2013 were reviewed. The study group comprised 143 consecutive patients with TPBS and 140 controls (CG). Data were collected from patient records and a phone survey was performed as a follow-up ≥ 4 years after the index ERCP. Results Post-ERCP pancreatitis (PEP) developed in seven patients (4.9%) in TPBS and one patient (0.7%) in CG (p = 0.067). The rates of other acute complications were similar between the groups. ERCP ended with no access to CBD in four cases (2.8%) in TPBS. The median length of follow-up was 6 years in TPBS and 7 years in CG. During this period, three patients (2.1%) in TPBS and six patients (4.3%) in CG suffered from acute pancreatitis (AP) (p = 0.238). One (0.7%) patient in CG and none in TPBS developed chronic pancreatitis (CP). Abdominal pain was suffered by ten patients (6.9%) in TPBS and twelve patients (8.6%) in CG daily, whereas by six patients (4.2%) in TPBS and twelve patients (8.6%) in CG weekly. Conclusion TPBS is a useful procedure, with acceptable complication rates. No significant difference occurred between the groups when evaluating the short-term or long-term complications with a follow-up period of four to 10 years. Additionally, no significant differences occurred in upper abdominal pain, episodes of AP, or development of CP.

Objectives Surgically altered anatomy complicates endoscopical procedures of pancreatobiliary tree. Biliary or hepaticojejunal anastomosis strictures have been managed using percutaneous transhepatic or double balloon enteroscopy (DBE) techniques with multiple plastic stents, or fully covered self-expandable metal stents. We report the first seven cases with surgically altered anatomy treated with biodegradable stents with DBE. Materials and methods Seven cases with altered anatomy, all with Roux-en-Y hepaticojejunostomy (HJ), were treated for HJ anastomosis strictures (3 cases) and intrahepatic biliary stricture (4 cases). Fujifilm DB enteroscope with a 200 cm long and 3.2 mm wide working channel was used. Balloon dilatations were first performed and then 1-3 biodegradable stents were deployed with a pusher over a guidewire. Results Two patients had HJ due to liver resections, one due to biliary injury in cholecystectomy and four due to liver transplantation because of primary sclerosing cholangitis (PSC). Median duration of the procedures was 56 min. Deployment of the stents took less than 20 min per patient. There were no stent or cholangiography related adverse events, but one patient required endotracheal intubation for nose bleeding caused by the placement of nasopharyngeal tube. Two PSC patients had recurrent cholangitis in the follow up. There was one stent migration in 90 day follow up. With all the HJ anastomotic strictures resolution of strictures seemed to be achieved. Conclusions Treatment of biliary or anastomosis strictures in altered anatomy is complex and time consuming. The biodegradable stent, which can be passed through working channel of a long enteroscope, seems promising in the treatment of these strictures. The benefit is that no stent removal is needed.

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.

Background: A dipstick test for urine trypsinogen-2 has been used in the diagnosis of acute pancreatitis, but there are only a few studies exploring the effectiveness of this test for early diagnose of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Goals: The authors explore if the rapid point-of-care urine trypsinogen-2 dipstick test can replace assay of amylase in diagnosing PEP. Study: For this prospective study, from Helsinki University Hospital 400 ERCP patients were enrolled in whom the authors analyzed plasma amylase or pancreas-specific amylase, bilirubin, and urine trypsinogen-2, and urine trypsinogen-2 with dipstick before, 4 and 24 hours after ERCP. Results: PEP developed in 15 (3.8%) patients. Urine trypsinogen-2 concentrations were significantly higher in PEP than in non-PEP patients 24 hours after ERCP (P=0.001, Mann-Whitney U test) but not 4 hours after ERCP (P=0.094). When combined with abdominal pain symptoms at 4 hours the dipstick test had a sensitivity of 60%, a specificity of 99%, a positive predictive value of 64%, and a negative predictive value 98%. At 24 hours, sensitivity was 100%, specificity 98%, positive predictive value 71%, and negative predictive value 100%. Conclusions: A positive dipstick seems to identify PEP cases and a negative test excludes PEP with high accuracy.

We explored prediction of severe acute pancreatitis (AP) and development of organ dysfunction (OD).Serum concentrations of serine peptidase inhibitor Kazal type 1 (SPINK1), trypsinogen 1, trypsinogen 2, and trypsinogen 3, complex between trypsin 2 and α1-antitrypsin, serum C-reactive protein, creatinine, and pancreatic amylase were measured in 239 AP patients with disease onset within 72 hours.SPINK1 distinguished most accurately patients who later developed severe AP. The area under the receiver operating characteristic curve for SPINK1 was 0.742, followed by trypsinogen 2 (0.726), complex between trypsin 2 and α1-antitrypsin (0.657), creatinine (0.656), trypsinogen 1 (0.652), trypsinogen 3 (0.557), and C-reactive protein (0.499). With a cutoff of 166 μg/L, SPINK1 had a specificity of 93%, a sensitivity of 48%, and diagnostic odds ratio of 11.52. In multivariate logistic regression analysis, only SPINK1 was an independent predictor of severe AP among patients presenting without OD on admission (P0.001).Plasma levels of the biomarkers and creatinine correlated with the severity of AP and development of OD. In patients presenting without OD at admission, SPINK1 was an independent marker for later development of severe AP.

Introduction: Acute Pancreatitis (AP) is the most frequent complication after Endoscopic Retrograde Cholangiopancreatography (ERCP). Some prophylactic strategies are the use of pancreatic stents or peri-procedural nonsteroidal anti-inflammatory drugs (NSAIDs). Statins are widely used lipid-lowering drugs. Recent studies suggest that chronic statin intake may be associated to a lower incidence of AP. Methods: Our aim is to investigate whether chronic statin and/or acetylsalicylic acid (ASA) intake is associated to a lower incidence of PEP. Stark project is an international, multicenter, prospective, cohort study, developed under the auspices of “Pancreas 2000”. Consecutive patients undergoing ERCP in seven european centers, older than 18, were included prospectively. Demographic and medical data were retrieved by anamnesis. Patients were followed-up to detect those with PEP. The sample size was estimated to be 1, 016 participants. A univariate analysis and multivariate analysis (binary logistic regression) were performed. Results: 1150 patients were included. Mean age was 68.4 years (SD 14.5). 561 (48.8%) patients were female. 70 patients developed post-ERCP-AP (PEP) (6.1%) ; 25 patients (8.1%) under chronic statin treatment versus 45 patients (5.4%) who do not (p= 0.086). Multivariate analysis showed an aOR of 1.679 (0.941-2.994), p 0.079 for PEP incidence in statin users. Regarding ASA consumption, 11 patients (6.6%) under ASA treatment versus 59 patients (6%) who were not consuming ASA, developed PEP (p= 0.753). Multivariate analysis showed an aOR of 1.017 (0.487-2.127), p=0.963 for PEP incidence among ASA users. Conclusion: Our data suggest that chronic statin and/or ASA intake isnt statistically associated to an increase incidence of PEP.

Iatrogenic bile duct injury (BDI) is a common complication after cholecystectomy. Patients are mainly treated endoscopically, but the optimal treatment method has remained unclear. The aim was to analyze endoscopic treatment in BDI after cholecystectomy and to explore endoscopic sphincterotomy (ES), with or without stenting, as the primary treatment for an Amsterdam type A bile leak. All patients referred to Helsinki University Hospital endoscopy unit due to a suspected BDI between the years 2004 and 2014 were included in this retrospective study. To collect the data, all ERC reports were reviewed. Of the 99 BDI patients, 94 (95%) had bile leak of whom 11 had concomitant stricture. Ninety-three percent of all patients were treated endoscopically. Seventy-one patients had native papillae and a leak in the cystic duct or peripheral radicals. They were treated with ES (ES group, n = 50) or with sphincterotomy and stenting (EST group, n = 21). There was no difference between the closure time of the fistula (p = 0.179), in the time of discharge from hospital (p = 0.298), or in the primary healing rate between the ES group and the EST group (45/50 vs 19/21 patients, p = 0.951). After the right patient selection, the success rate of endoscopic treatment can approach 100% for Amsterdam type A bile leak. ES is an effective and cost-effective single procedure with success rate similar to EST. It may be considered as a first-line therapy for the management of Amsterdam type A leaks.

Background Nonsteroidal anti-inflammatory drugs have an inhibitory role in pathogenesis of pancreatitis. Guidelines from the European Society of Gastrointestinal Endoscopy recommend routine rectal administration of 100 mg of diclofenac or indomethacin immediately before or after ERCP for all patients without contraindications. Aims Our aim was to evaluate the effect of diclofenac in preventing post-ERCP pancreatitis (PEP) in a high-volume, low-PEP-risk ERCP unit. Methods The rate and severity of PEP were compared in groups of 1000 historical controls prior to the routine use of diclofenac and in 1000 patients receiving 100 mg diclofenac before ERCP. Results PEP occurred in 56 (2.8%) of the 2000 patients, and the rate of the pancreatitis was 2.8% in control group and 2.8% in diclofenac group (p = 1.000). The PEP rate among the native papilla patients was 3.9% in control group and 3.6% in diclofenac group (p = 0.803). In subgroup analysis of patients with a high risk of PEP, diclofenac neither prevented PEP nor made its course milder. Conclusions In an unselected patient population in a center with a low incidence of PEP, diclofenac seems to have no beneficial effect.