Therapeutic ERCP Research Articles

The most dangerous factors for pancreatitis after ERCP – systematic review with a prevention approach

Summary Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is the most prevalent and harmful side effect of diagnostic and therapeutic ERCP. Identifying high risk patients and subsequent selection of alternative diagnostic methods needs a multifactorial study of PEP (post-ERCP pancreatitis) risk variables. To determine the most hazardous PEP-related variables, a systematic study was conducted. In order to find relevant studies published between 1/1/2017 and 1/10/2022, two independent researchers conducted searches (MT, SH R). A literature search of English language publications was conducted using MEDLINE through PubMed, EMBASETM through Ovid, the Cochrane Library, and Trip. In addition to Magiran and SID, we searched KoreaMed and LILACS for literature published in other languages. Endoscopic retrograde cholangiopancreatography OR Pancreatitis OR Risk factors OR ERCP OR Systematic review were used in the search strategy. A total of 174 studies were selected. After analyzing their compliance with the required criteria, a final review of five studies was conducted. This article presents the current findings on the most critical risk factors for post-ERCP pancreatitis. The most frequent ERCP operation side effect is PEP, which concerns individuals with high-risk factors. There is significant debate over PEP‘s pathophysiology. Due to its complex pathophysiology, PEP prevention should include a variety of criteria, including patient-related risk factors, pharmacological prophylaxis, and procedural methods. The patient‘s age, gender, and previous history of the disease are the most critical risk factors for pancreatitis after ERCP. Keywords pancreatitis, endoscopic retrograde cholangiography, risk factors, ERCP, PEP,

A therapeutic ERCP in an only 5.9 kg infant with obstruction jaundice using JF-260V duodenoscope

BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) has found extensive use in pediatric patients; however, challenges persist in the application of therapeutic ERCP in infants.Case presentationThis case report details the presentation of a 5.9-kilogram infant with obstructive jaundice and suspected hemolytic anemia who underwent ERCP to alleviate biliary obstruction. The infant was admitted due to clay-colored stools, jaundice, and liver injury. Ultrasound and magnetic resonance cholangiopancreatography (MRCP) revealed dilation of the common bile duct (CBD) accompanied by the presence of stones. ERCP was conducted using a JF-260V duodenoscope under general anesthesia. Successful stone extraction and biliary drainage were achieved.ConclusionsIn centers with considerable expertise in ERCP and pediatric anesthesia, the use of a conventional adult duodenoscope for therapeutic ERCP in infants can be considered safe and feasible, provided careful and stringent patient selection criteria are applied. In the future, clear guidelines and standardized protocols for the indications and procedures of pediatric ERCP should be established.

Safety, risk stratification, and cost of ERCP in patients with cirrhosis: a prospective controlled study

IntroductionGiven that ERCP has major procedure-related complications in non-cirrhotic patients, the complications and the cost of therapeutic ERCP were not studied in cirrhotic patients.AimWe aimed to study the complications and cost of ERCP compared to patients without cirrhosis.Patients and methodsOutcome and complications of therapeutic ERCP were prospectively studied in patients with cirrhosis and compared to patients without cirrhosis undergoing ERCP. Patients with cirrhosis were evaluated using the Child-Pugh classification, MELD, MELD Na, and APRI scores. Safety was assessed up to 30 days following the procedure.ResultsPancreatitis, perforation, bleeding, and cardiopulmonary complications were not different in both groups (8% vs. 9.3, 0% vs. 2%, 3.3% vs. 4%, and 4% vs. 2% respectively), while cholangitis occurred more frequently in cirrhosis (13.3% vs. 1.3% respectively). Hospital stay was longer, and mortality and costs were significantly higher among patients with cirrhosis. Patients with Child C cirrhosis developed more complications and had higher mortality. A MELD score cut-off of ≥ 11.5 separated all mortalities. Similarly, MELD-Na and APRI separated patients with cirrhosis who had more frequent complications and mortalities.ConclusionsPatients with cirrhosis experienced more complications and costs, and cirrhotic patients who developed moderate to severe complications were more likely to die.

Instant duodenal decompression after endoscopic retrograde cholangiopancreatography can effectively reduce the incidence of post-ERCP pancreatitis and hyperamylasemia.

Post-ERCP pancreatitis (PEP) is significantly influenced by the reflux of duodenal fluid. While gastrointestinal decompression represents a fundamental approach in acute pancreatitis management, the effectiveness of immediate duodenal decompression following ERCP to prevent PEP remains uncertain. This study aimed to investigate the impact of immediate duodenal decompression after ERCP on reducing the incidence of hyperamylasemia and PEP. This retrospective study encompassed patients with native papilla who underwent therapeutic ERCP for choledocholithiasis at the Department of Gastroenterology, Chun'an Branch of Zhejiang Provincial People's Hospital (Zhejiang, China) between January 2020 and June 2023. Based on the immediate placement of a duodenal decompression tube post-ERCP, patients were categorized into two groups: the duodenal decompression group and the conventional procedure group. Primary outcomes included the incidence of PEP and hyperamylasemia. A total of 195 patients were enrolled (94 in the duodenal decompression group and 101 in the conventional procedure group). Baseline clinical and procedural characteristics exhibited no significant differences between the two groups. PEP occurred in 2 patients (2.1%) in the duodenal decompression group, in contrast to 11 patients (10.9%) in the conventional procedure group (Risk difference [RD] 8.8%; 95% confidence interval [CI] 1.7%-16.5%, P = 0.014). Hyperamylasemia was observed in 8 patients (8.5%) in the duodenal decompression group, compared to 20 patients (19.8%) in the conventional procedure group (RD 11.3%; 95% CI 1.4%-21.0%; P = 0.025). Patients with PEP in both groups showed improvement after receiving active treatment. No severe cases of PEP occurred in either group, and no serious adverse events related to duodenal catheter decompression were reported. Immediate duodenal decompression following ERCP demonstrates an effective reduction in the incidence of hyperamylasemia and PEP.

Diagnosis of functional strictures in patients with primary sclerosing cholangitis using hepatobiliary contrast-enhanced MRI: a proof-of-concept study

ObjectivesPSC strictures are routinely diagnosed on T2-MRCP as dominant- (DS) or high-grade stricture (HGS). However, high inter-observer variability limits their utility. We introduce the “potential functional stricture” (PFS) on T1-weighted hepatobiliary-phase images of gadoxetic acid-enhanced MR cholangiography (T1-MRC) to assess inter-reader agreement on diagnosis, location, and prognostic value of PFS on T1-MRC vs. DS or HGS on T2-MRCP in PSC patients, using ERCP as the gold standard.MethodsSix blinded readers independently reviewed 129 MRIs to diagnose and locate stricture, if present. DS/HGS was determined on T2-MRCP. On T1-MRC, PFS was diagnosed if no GA excretion was seen in the CBD, hilum or distal RHD, or LHD. If excretion was normal, “no functional stricture” (NFS) was diagnosed. T1-MRC diagnoses (NFS = 87; PFS = 42) were correlated with ERCP, clinical scores, labs, splenic volume, and clinical events. Statistical analyses included Kaplan–Meier curves and Cox regression.ResultsInterobserver agreement was almost perfect for NFS vs. PFS diagnosis, but fair to moderate for DS and HGS. Forty-four ERCPs in 129 patients (34.1%) were performed, 39 in PFS (92.9%), and, due to clinical suspicion, five in NFS (5.7%) patients. PFS and NFS diagnoses had 100% PPV and 100% NPV, respectively. Labs and clinical scores were significantly worse for PFS vs. NFS. PFS patients underwent more diagnostic and therapeutic ERCPs, experienced more clinical events, and reached significantly more endpoints (p < 0.001) than those with NFS. Multivariate analysis identified PFS as an independent risk factor for liver-related events.ConclusionT1-MRC was superior to T2-MRCP for stricture diagnosis, stricture location, and prognostication.Clinical relevance statementBecause half of PSC patients will develop clinically-relevant strictures over the course of the disease, earlier more confident diagnosis and correct localization of functional stricture on gadoxetic acid-enhanced MRI may optimize management and improve prognostication.Key Points• There is no consensus regarding biliary stricture imaging features in PSC that have clinical relevance.• Twenty-minute T1-weighted MRC images correctly classified PSC patients with potential (PFS) vs with no functional stricture (NFS).• T1-MRC diagnoses may reduce the burden of diagnostic ERCPs.Graphical abstract

Utilization pattern of prophylactic measures for prevention of post-ERCP pancreatitis: a National Survey Study.

Post-ERCP pancreatitis (PEP) is the most frequent adverse event of ERCP. Various prophylactic measures are endorsed by the American Society for Gastrointestinal Endoscopy and the European Society of Gastrointestinal Endoscopy to both lower the incidence of PEP and to decrease its severity. The extent to which these interventions are practiced throughout the United States is unclear. The aim of this study was to describe the utilization pattern of various PEP measures and determine factors that affect utilization of these measures. A 27-question electronic survey was distributed using a cloud-based program (Qualtrics). The questions assessed ERCP training, practice setting, experience, practice patterns, and perceptions for PEP prophylaxis interventions. Endoscopists with practices based in the United States listed in the American Society for Gastrointestinal Endoscopy member directory received a survey invitation via e-mail. The invitation outlined the study and contained a link with instructions to complete the voluntary survey if they had an active ERCP practice. Data were de-identified for the purposes of analysis. Of survey respondents (N= 319), 46% reported therapeutic endoscopy fellowship training and 37% practiced in teaching programs. Annualized ERCP volume of >100 cases per year were reported by 47%, with pancreatic ERCP comprising≤5% of procedure volume reported by the majority of respondents (61%). The majority of respondents used prophylactic pancreatic stent (PPS), and 54% reported frequent use during high-risk ERCP. The most common indications for PPS were difficult cannulation, to assist biliary access, and multiple pancreatic duct injections. Most respondents reported frequent use of indomethacin (89%). Of physicians who did not use PPS, use of indomethacin was the most common reason (80%). Variables associated with frequent use of PPS were ERCP fellowship training (P≤ .001), practice at a teaching program (P≤ .001),<10 years in practice (P= .005), higher procedure volume (P≤ .001), and higher proportion of pancreatic cases (P≤ .001). Physicians with higher annual ERCP volume, who teach at hospital-based ERCP practices, and who regularly perform pancreatic ERCP are more likely to use PPS. Therapeutic ERCP fellowship training and recent entry into practice were also associated with PPS utilization. Indomethacin use seems to be more frequent than PPS. Our findings suggest that indomethacin is supplanting PPS as the preferred method of PEP prophylaxis.

Efficacy of a newly developed guidewire for selective biliary access

A clinical efficacy study of 0.025-inch guidewires (GWs) according to mechanical property analysis has not been reported yet. This study was designed to evaluate the clinical efficacy of a newly developed 0.025-inch GW for biliary access according to the basic mechanical property. Commercially available 0.025-inch GWs were in vitro tested based on parameters of mechanical property. Patients with naïve papilla requiring diagnostic or therapeutic ERCP were randomly assigned to an experimental 0.025-inch newly developed GW or a control 0.025-inch GW group. Technical success rate of wire-guided cannulation (WGC), difficult biliary cannulation (DBC), and adverse event rates were measured in this multicenter randomized trial. The technical success rate of primary WGC was 79.1% (151 of 191) in the experimental group and 70.8% (131 of 185) in the control group (95% two-sided confidence interval: 8.25%; p < 0.001; for a noninferiority margin of 15%). The technical success rate including cross-over to each other was also non-inferior. However, the chi-square test showed a statistical difference (81.7% vs. 68.1%; p = 0.002). Median biliary cannulation time was shorter in the experimental group (53 s vs. 77 s; p = 0.047). The rate of DBC was more frequent in the control group (34.6% vs. 50.3% p = 0.002). Multivariate analysis revealed that control group was one of contributing factors for DBC. Overall rate of post-ERCP pancreatitis was not different (4.7% vs. 8.6%; p = 0.125). WGC using a newly developed GW with superior physical performance GW in a bench test showed similar clinical efficacy and the rate of DBC was significantly lower in experimental GW.

Characteristics, management and outcomes of choledochal malformations in Finnish adult patients

Aim: We aimed to assess management, comorbidities, biliary histopathology and outcomes of choledochal malformations (CM) in adults. Methods: All adult CM patients managed during 1987–2021 at the Helsinki University Hospital were retrospectively reviewed. Results: Of the 39 patients (females 79%) identified, 19 (49%) underwent surgery, 5 (13%) therapeutic ERCP with papillotomy for type 3 CM and 15 (38%) were managed conservatively. Twenty-five (66%) patients had ≥1 comorbidity, and five (13%) patients had associated inflammatory bowel disease (IBD); ulcerative colitis (n = 3) and Crohn’s disease (n = 2). Most surgically treated patients underwent hepaticojejunostomy (n = 13) or pancreaticoduodenectomy (n = 3) and they were younger at presentation than other patients [29 (21 – 48) vs. 59 (41 – 71), p = 0.001]. Three patients (23%) suffered from pancreatitis following diagnostic ERCP. Early surgical complications occurred in six (32%) patients, including one anastomotic leakage. Biliary epithelial dysplasia was found in three (15%) patients in resected specimens, while no neoplastic changes were observed. Nine patients (47%) had long-term postoperative complications, cholangitis (n = 5) and anastomotic stricture (n = 3) being the most common ones. No evidence of malignant change was observed after median follow-up of 2.3 (0.60 − 4.5) years included all patient cohorts. Conservatively managed patients remained symptomless with unprogressive biliary tract imaging findings and normal liver biochemistry values during follow-up. Conclusions Nearly half of operated patients developed long-term postoperative complications. A novel association between CMs and IBD was observed. Although no hepatobiliary malignancies regardless of treatment modality were encountered, the number of patients and length of follow-up remained limited.

Development of a scoring system with laboratory and ultrasound parameters to predict the choledocholithiasis

Importance: ERCP is an effective method for this pathology but requires that reliable preoperative markers for the presence of choledocholithiasis are established to reduce the number of unnecessary endoscopic procedures. Objective: Develop a system of scoring with ultrasound and laboratory parameters to predict choledocholithiasis. Design, setting, and participants: It is an analytical, prospective, and quantitative study tested diagnostic (sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratio). The universe is represented by a total of 600 patients that were treated in the surgery service of the Hospital with Hepatobiliopancreatic pathology, the sample is represented by 400 patients of the universe, from January 2012 to July 2016. Exposures: It was conducted using a pre-established protocol review of medical records of Viedma Clinical Hospital. Main Outcome and Measures Determine if using simple a lab test along with the abdominal ultrasound, you can predict the existence of choledocholithiasis and decide to perform therapeutic ERCP. Results: By subjecting all patients studied to the scoring scale, we can see that those with one higher score (add of) &gt;4 have a 31% chance to find stones in the bile duct, and which those which have a score &lt;4 have a 5% chance to find stones in his bile duct, therefore the use of this scoring scale allows us to predict 6 times the probability of present gallstones in the bile duct that if we don't use the same. Conclusion and relevance: The use of diagnostic tests (sensitivity, specificity, predictive value, and likelihood ratio) are effective tests for their discriminatory power between sick and healthy patients. Patients with 4 or more criteria achieve a sensitivity of 66% and a specificity of 90% to predict choledocholithiasis.

Alterations in the pH of pancreatic juice are associated with chymotrypsin C inactivation and lithostathine precipitation in chronic pancreatitis patients: a proteomic approach

BackgroundThe progression of chronic pancreatitis (CP), an inflammatory disease of the pancreas, causes pancreatic stones to form within the pancreatic ductal lumen/parenchyma, which occurs via protein plug formation. Pain is the most common symptom that necessitates clinical attention, and pain relief is the therapeutic goal for these patients. Endoscopic therapy and surgery are complimentary forms of therapy for pain relief. This study was envisaged to clarify the mechanism by which protein plug/soft stones form in pancreatic ducts prior to undergoing calcification.MethodsProtein plugs were obtained from twenty CP patients undergoing therapeutic ERCP for stone removal. Pancreatic juice was obtained from five CP patients without stones. Proteins were isolated by TCA/acetone precipitation, SDS PAGE and 2-D gel electrophoresis to determine the protein profile. Protein spots from the 2-D gel were excised and subjected to matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) for identification. The effect of altered pH and elevated concentrations of trypsin on pancreatic juice protein was assessed by SDS‒PAGE to determine the protein profile. Differentially expressed protein bands were excised and subjected to MALDI-TOF. In silico analysis was performed by docking lithostathine with the calcite molecule using AutoDock Vina and PyMOL to clarify their interaction during stone formation.ResultsTwenty-three and twenty-nine spots from 2D gels of protein plugs and pancreatic juice, respectively, revealed that lithostathine (Reg1A) was the only protein in the protein plugs, whereas digestive enzymes and lithostathine were identified in pancreatic juice. Altered pH levels and increased trypsin concentrations in the pancreatic juice caused a protein to degrade via an unknown mechanism, and this protein was identified as chymotrypsin C (CTRC) by MALDI-TOF. Docking studies showed that the binding affinity of calcite was higher with the cleaved lithostathine, explaining the deposition of calcium that was observed around the protein plugs after calcified stones were formed through precipitation.ConclusionOur results suggest that chymotrypsin C (CTRC) is degraded in an acidic environment, leading to the precipitation of lithostathine in the ductal lumen.Graphical

One hundred most cited articles related to Endoscopic retrograde cholangiopancreatography: A bibliometric analysis.

Endoscopic retrograde cholangiopancreatography (ERCP) has developed over the past few decades into a reliable technology for diagnostic and therapeutic purposes. Through a bibliometric analysis, this research attempted to evaluate the characteristics of the top 100 articles on ERCP that had the most citations. We extracted pertinent publications from the Web of Science Core Collection (WoSCC) on July 9, 2022. The top 100 ERCP articles with the most citations were identified and analyzed. The following data were extracted: publication year, country/region, organization, total citation times, annual citation times, research type and research field, etc. To implement the network's visual analysis, a bibliographic coupling network based on keywords was built using the VOSviewer 1.6.17 program. The journal with the most publications were GASTROINTESTINAL ENDOSCOPY, with 45 articles. Most of the top 100 articles came from the United States (n = 47) and Italy (n = 14). Indiana University and the University of Amsterdam were among the most important institutions in ERCP research. ML Freeman of the University of Minnesota contributed the highest number (n = 9) and the most highly cited paper. The age of the paper and article type is closely related to citation frequency. Of the 100 most-cited articles, clinical application in the field of ERCP has focused on three aspects: diagnosis, treatment, and complications. Clinical use of ERCP has shifted from diagnosis to treatment. Post-ERCP pancreatitis is the focus of attention, and the clinical application of technically complex therapeutic ERCP is the future development trend. This study lists the most influential articles in ERCP by exposing the current state of the field, and showing the evolution of research trends to provide perspective for the future development of ERCP.

Cytology of Bile Duct Brushings: Streaming Ahead with Time

Endoscopic retrograde brush cytology of the biliary duct is an established tool for evaluation of obstructive biliary strictures or screening of primary sclerosing cholangitis (PSC) patients for dysplasia. It is a simple, minimally invasive procedure that can be performed during a therapeutic ERCP. Most authors have reported a sensitivity of 30-60% and a specificity of 90-100%. A positive result can be a reliable indicator of malignant neoplasm. However, there is no standardized reporting terminology designed specifically for bile duct brushings. Majority of bile duct brushings yield either benign ductal epithelium, reactive atypia of ductal epithelium or suspicious/positive for malignancy. Diagnosing malignancy in bile duct brushings is based on a constellation of cytologic features, and consideration of the overall picture- clinical presentation, radiology/endoscopy findings, etc. Different studies have highlighted various key features for diagnosing malignancy in bile duct brushings. Features most consistently associated with a malignant category are- loss of honeycomb architecture, 3D clusters, high n:c ratio, anisonucleosis (≥1:4 variation), irregular nuclear outlines, coarse clumped chromatin, and single malignant cells in the background. The utility of biliary brush cytology has been expanded by using FISH, immunocytochemistry, and Next-generation sequencing.

Guidewire-assisted cannulation of the common bile duct for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.

Cannulation techniques have been recognized as being important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP. To assess the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP in people undergoing diagnostic or therapeutic ERCP for biliary or pancreatic diseases. For the previous version of this review, we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL and major conference proceedings, up to February 2012, with no language restrictions. An updated search was performed on 26 February 2021 for the current version of this review. Two clinical trial registries, clinicaltrials.govand WHO ICTRP, were also searched in this update. Randomized controlled trials (RCTs) comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in people undergoing ERCP. Two review authors conducted study selection, data extraction, and methodological quality assessment independently. Using intention-to-treat analysis with random-effects models, we combined dichotomous data to obtain risk ratios (RR) with 95% confidence intervals (CI). We assessed heterogeneity using the Chi² test (P < 0.10) and I² statistic (> 50%). To explore sources of heterogeneity, we conducted a priori subgroup analyses according to trial design, publication type, risk of bias, use of precut sphincterotomy, inadvertent guidewire insertion or contrast injection of the pancreatic duct (PD), use of a PD stent, cannulation device, and trainee involvement in cannulation. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR versus odds ratio (OR)) and meta-analytic models (fixed-effect versus random-effects) and per-protocol analysis. 15 RCTs comprising 4426 participants were included. There was moderate heterogeneity among trials for the outcome of PEP (P = 0.08, I² = 36%). Meta-analyses suggest that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique (RR 0.51, 95% CI 0.36 to 0.72, 15 studies, moderate-certainty evidence). In addition, the guidewire-assisted cannulation technique may result in an increase in primary cannulation success (RR 1.06, 95% CI 1.01 to 1.12, 13 studies, low-certainty evidence), and probably reduces the need for precut sphincterotomy (RR 0.79, 95% CI 0.64 to 0.96, 10 studies, moderate-certainty evidence). Compared to the contrast-assisted cannulation technique, the guidewire-assisted cannulation technique may result in little to no difference in the risk of post-sphincterotomy bleeding (RR 0.87, 95% CI 0.49 to 1.54, 7 studies, low-certainty evidence) and perforation (RR 0.93, 95% CI 0.11 to 8.23, 8 studies, very low-certainty evidence). Procedure-related mortality was reported by eight studies, and there were no cases of deaths in both arms (moderate-certainty evidence).Subgroup analyses suggest that the heterogeneity for the outcome of PEP could be explained by differences in trial design. The results were robust in sensitivity analyses. There is moderate-certainty evidence that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique. There is low-certainty evidence that the guidewire-assisted cannulation technique may result in an increase in primary cannulation success. There is low- and very low-certainty evidence that the guidewire-assisted cannulation technique may result in little to no difference in the risk of bleeding and perforation. No procedure-related deaths were reported. Therefore, the guidewire-assisted cannulation technique appears to be superior to the contrast-assisted cannulation technique considering the certainty of evidence and the balance of benefits and harms. However, the routine use of guidewires in biliary cannulation will be dependent on local expertise, availability, and cost. Future research should assess the effectiveness and safety of the guidewire-assisted cannulation technique in the context of other pharmacologic or non-pharmacologic interventions for the prevention of PEP.

Multidisciplinary Management of Common Bile Duct Stones: A Single Centre Experience of 844 Patients over a Five and a Half Year Period

Background: CBD stone diagnosis and management has deeply changed during the last 30 years, with the inclusion of imaging, like EUS and MRCP and laparoscopy. We present our data on the contemporary management of CBD stones. Methods: A retrospective study of case records of patients treated for CBD stones from jan 2012 to jun 2017 at our institute was undertaken. Various methods of treatment (endoscopic, surgical, interventional radiology) and their complications were taken into account. Results: 844 patients treated for CBD stones in a period of 66 months. 418 patients were males and 426 were females. The median age was 56yrs(6-94 yrs). EUS was performed on all patients.Our data showed sensitivity(95.75%) and PPV (95.27%) of EUS over MRI(Sensitivity 93.5%, PPV 95.08%).This was followed by therapeutic ERCP on the same day if EUS was positive for stones. Only sick patients with cholangitis underwent ERCP drainage as primary procedure. Of the 1592 ERCPs performed, 889 were performed for CBD stones. Our Success rate was 89.7%. Surgical Intervention was required in 532 cases. In 386 patients, laparoscopic cholecystectomy was performed within 48 hrs of the ERCP and were discharged home with 3-5 days of hospital stay.There were 35 interval cholecystectomies, 67 laparoscopic CBD explorations and 25 open explorations.Surgical complications were minimal- 3 patients having collection in GB fossa, 1 with port site abscess. Conclusion: This combined use of EUS, ERCP and Laparoscopy results in excellent success rates of common bile duct clearance and near zero mortality over a large series of cases.

Safety, Risk Stratification and Cost of ERCP in Patients with Cirrhosis

Introduction: Procedure related complications and cost of therapeutic ERCP in patients with cirrhosis were compared to patients without cirrhosis. Disease severity scores were used to stratify procedure risks. Patients and Methods: Outcome and complications of therapeutic ERCP were prospectively studied in patients with cirrhosis and compared to patients without cirrhosis undergoing ERCP. Patients with cirrhosis were evaluated using liver scores. Results: The study included 150 patients with cirrhosis (60% males, mean age 60+/-12.4 years), and 150 patients without cirrhosis (56% males, mean age 52.4+/-20.3 years). Biliary cannulation was successful in 98% and 98.3% of patients with and without cirrhosis. Clinical pancreatitis, perforation, bleeding and cardiopulmonary complications were not different in patients with and without cirrhosis (8% vs 9.3, 0% vs 2%, 3.3% vs 4%, and 4% vs 2% respectively), while cholangitis occurred more frequently in patients with cirrhosis (13.3% vs 1.3% respectively). Hospital stay was longer and mortality and costs were significantly higher among patients with cirrhosis. Patients with Child C cirrhosis developed more complications and had higher mortality. A MELD score cut off of ≥11.5 separated all mortalities. Conclusions: Patients with cirrhosis experienced more complications and costs, and patients with cirrhosis who developed moderate to severe complications were more likely to die.

Prospective study of EUS guided ERCP or IOC approach in the detection of common bile duct stones in patients undergoing cholecystectomy

Introduction: Choledocholithiasis (common bile duct stones) develops in up to 20 percent of patients with gallbladder stones. It is generally accepted that stones in the common bile duct (CBD) should be removed, even if patients are asymptomatic, because they may be associated with severe complications such as pancreatitis and cholangitis. Materials and Methods: This is a Prospective and analytical study conducted at Department of Surgical Gastroentrology in a Tertiary care Teaching Hospital with suspected common bile duct stones consenting to study protocol were recruited and outcome on management was recorded for each arm of the study over a period of 1 year. In positive EUS group, therapeutic ERCP was performed at the same EUS session or later if CBD stone was found. In the EUS group negative for CBD stones, IOC was performed during laparoscopic cholecystectomy. Result: Mean patient age was 62 years (range, 44 to 74 years), 12 were women and 7 men. Eight of 19 patients (42%) had undergone a previous cholecystectomy; none had undergone previous ERCP. Seven patients (37%) had mild acute biliary pancreatitis (Glasgow score &lt;3) at admission. Six patients, who were referred by other hospitals for EUS, previously had undergone MRCP without evidence of biliary stones. Conclusion: MRCP and EUS have only diagnostic roles, and ERCP is needed for therapeutic purposes. It has been suggested that, when CBDS are found at EUS, they should be treated in the same session. Ideally EUS should be performed in a facility that allows ERCP and to be performed immediately thereafter with no interruption.

S970 New Automated Cleaning System Is More Effective in Reducing Bioburden vs Standard Manual Clean in Duodenoscopes

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein < 6.4 ug/cm^2 and carbohydrates < 2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology. Methods: A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning. Results: The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p = 0.03). Conclusion: Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device – involving multiple channels and an elevator mechanism at the distal tip – makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes.Table 1.: Residual Protein and Carbohydrate Post Manual Versus Automated Clean *One manually cleaned duodenoscope had levels of both protein and carbohydrate above FDA threshold.

Cost-effectiveness analysis of optimal diagnostic strategy for patients with symptomatic cholelithiasis with intermediate probability for choledocholithiasis

EUS, MRCP, and intraoperative cholangiogram (IOC) are the recommended diagnostic modalities for patients with intermediate probability for choledocholithiasis (IPC). The relative cost-effectiveness of these modalities in patients with cholelithiasis and IPC is understudied. We developed a decision tree for diagnosing IPC (base-case probability, 50%; range, 10%-70%); patients with a positive test were modeled to undergo therapeutic ERCP. The strategies tested were laparoscopic cholecystectomy with IOC (LC-IOC), MRCP, single-session EUS+ ERCP, and separate-session EUS+ ERCP. Costs and probabilities were extracted from the published literature. Effectiveness was assessed by assigning utility scores to health states, average proportion of true-positive diagnosis of IPC, and the mean length of stay (LOS) per strategy. Cost-effectiveness was assessed by extrapolating a net-monetary benefit (NMB) and average cost per true-positive diagnosis. LC-IOC was the most cost-effective strategy to diagnose IPC (base-case probability of 50%) among patients with cholelithiasis in health state-based effectiveness analysis (NMB of $34,612), diagnostic test accuracy-based effectiveness analysis (average cost of $13,260 per true-positive diagnosis), and LOS-based effectiveness analysis (mean LOS of 4.13) compared with strategies 2 (MRCP), 3 (single-session EUS+ ERCP), and 4 (separate-session EUS+ ERCP). These findings were robust on deterministic and probabilistic sensitivity analyses. For patients with cholelithiasis with IPC, LC-IOC is a cost-effective approach that should limit preoperative testing and may shorten hospital LOS. Our findings may be used to design institutional and organizational management protocols.

Is Insulin-Like Growth Factor-I (IGF-I) efficient as a Diagnostic ‎Biomarker in Differentiating Cholangiocarcinoma from Benign ‎Biliary Obstruction?‎‎

Background and study aim: Cholangiocarcinoma (CCA) is a rarely curable cancer and is infrequently diagnosed early. There is a ‎growing interest in evaluating CCA biomarkers in serum and bile. CCA cells express insulin-like growth ‎factor-I (IGF-I) which modulates cell growth and reduces apoptosis.‎ The aim of this study is to evaluate biliary and serum IGF-I as diagnostic biomarkers in patients with extrahepatic ‎cholangio-carcinoma vs. benign biliary obstruction‎‎‎‎. Patients and Method: We conducted a prospective cross-sectional study on 60 patients with extrahepatic biliary obstruction ‎divided into: CCA group (n=30) and benign obstruction (n=30). All patients had diagnostic and therapeutic ‎ERCP with IGF-I assessment in serum and bile‎‎.‎ Results: The CCA group mean age was significantly higher than the benign obstruction group (69.0±4.68 vs. ‎‎56.0±6.47years, p˂0.001). The etiologies of benign biliary obstruction were bile duct stones (n=18), benign ‎stricture (n=11) and cholangitis (n=2). The mean biliary IGF-I in CCA patients was significantly higher (19-‎‎20 folds) than the benign biliary obstruction group (639.14±86.77 vs. 33.60±8.75, p˂0.001). The mean ‎serum IGF-I in the CAA group was higher than the benign group, however, this was non-significant ‎‎(223.06±76.53 vs. 198.34±38.74, p=0.192). Biliary IGF-I cutoff of 292.24ng/ml in CCA vs. benign group ‎showed 100% sensitivity and specificity (AUC=1, p=<0.001). While a serum IGF-I cutoff of 236.32ng/mL ‎in CCA vs. benign group showed a sensitivity/ specificity of 50%/80% respectively (AUC=0.614, p=0.081)‎. Conclusion: Biliary but not serum IGF-I was an excellent marker in differentiating extrahepatic CCA from extrahepatic ‎benign biliary obstruction with a 100% sensitivity and specificity. The diagnostic utility of serum IGF-I in ‎biliary malignancies needs further study‎ ‎‎.

ERCP-related perforations: covert or overt adverse events? A prospective case series

Background Perforations related to endoscopic retrograde cholangiopancreatography are a rare but feared adverse events, with significant morbidity and mortality. In order to describe the potential patient profiles related to post-ERCP perforations we present a case series of three patients, documenting several particular aspects related to their ERCP related complications. Material and methods: Between 01.01.2018 and 31.08.2020 a total of 403 patients underwent therapeutic ERCP in the tertiary medical center represented by “Sf. Spiridon” County Clinical Emergency Hospital, Iasi, Romania. Three duodenal and pancreaticobiliary perforations were identified (0.74%). Results: Three types of perforations (according to Stapfer et al., 2000 classification) were described: type 2, type 3 and type 4. All patients presented patient-related risk factors and developed post-ERCP comorbidities that proved to be of significant impact to their prognosis resulting in two cases of fatal outcome. Given each case particularities, positive diagnosis was established using cross-sectional imaging. The therapeutical approach was complex and included surgical treatment, as advocated in current literature. Conclusions: Post-procedural diagnosis of perforations can prove to be challenging but an early diagnosis, an appropriate therapeutic approach and a well conducted post-procedural patient surveillance can significantly improve patient outcome.