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Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that requires abundant clinical experience and endoscopic skills, and can lead to various complications, some of which may progress to life-threatening conditions. With expanding indications and technological advancements, ERCP is widely utilized, enhancing procedural accessibility. However, without proper quality management, the procedure can pose significant risks. Quality management in ERCP is essential to ensure safe and successful procedures and meet societal demands for improved healthcare competitiveness. To address these concerns, the Korean Society of Pancreatobiliary Endoscopy has developed a Korean-specific ERCP quality indicator reflecting domestic medical environments and realities. Initially, based on a review of foreign ERCP quality indicators and related literatures, key questions were formulated for five pre-procedural items, three intra-procedural items, and four post-procedural items. Descriptions and recommendations for each item were selected through peer evaluation. The developed Korean-specific ERCP quality indicator was reviewed by external experts based on the latest evidence and consensus in this fields. This Korean-specific indicator is expected to significantly contribute to improving ERCP quality in Korea, as it is tailored to local needs.

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that requires significant experiences and skills and has various procedure-related complications, some of which can be severe and even result in the death of patients. Expanding ERCP availability has the advantage of increasing accessibility for patients. However, ERCP poses a substantial risk if performed without proper quality management. ERCP quality management is essential for both ensuring safe and successful procedures and meeting the social demands for enhanced healthcare competitiveness and quality assurance. To address these concerns, the Korean Pancreatobiliary Association established a task force to develop ERCP quality indicators (QIs) tailored to the Korean medical environment. Key questions for five pre-procedure, three intra-procedure, and four post-procedure measures were formulated based on a literature search related to ERCP QIs and a comprehensive clinical review conducted by experts. The statements and recommendations regarding each QI item were selected through peer review. The developed ERCP QIs were reviewed by external experts based on the latest available evidence at the time of development. These domestically tailored ERCP QIs are expected to contribute considerably to improving ERCP quality in Korea.

Background: Hypoxia is the most frequently occurring adverse effect during endoscopic retrograde cholangiopancreatography (ERCP) under sedation; thus, oxygen must be properly supplied to prevent a reduction of oxygen saturation. In this study, we intend to verify the preventive effect for hypoxia during ERCP, using a high-flow nasal cannula (HFNC), in elderly patients., Methods: As a multicenter prospective randomized trial, patients who underwent ERCP with propofol-based sedation were randomly assigned into two groups: Patients in the HFNC group were supplied with oxygen via an HFNC, and those in the standard nasal cannula group were supplied with oxygen via a low-flow nasal cannula. The co-primary end points were the lowest oxygen saturation rate and hypoxia during the overall procedure., Results: A total of 187 patients (HFNC group: 95; standard nasal cannula group: 92) were included in the analysis. Unexpected hypoxia events were more frequently observed among patients in the standard nasal cannula group than among patients in the HFNC group (13% vs. 4%, odds ratio 3.41, 95% confidence interval 1.06-11.00, p = 0.031). The mean of the lowest oxygen saturation rate during ERCP was significantly lower in the standard nasal cannula group than in the HFNC group (95% vs. 97%, p = 0.002)., Conclusion: Oxygen supplementation with an HFNC can prevent oxygen desaturation and hypoxia events in patients undergoing ERCP under sedation. Trial registration Clinical Research Information Service (CRIS; KCT0004960)., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Hypoxemia can occur during endoscopic retrograde cholangiography (ERCP) and it is difficult to achieve adequate ventilation with the prone position. High-flow nasal oxygen (HFNO) has been recommended to be more effectively help ventilation than conventional low flow oxygen. The aim of this study was to evaluate the effect of HFNO during sedated ERCP and to identify predictors of desaturation during ERCP. The investigated variables were age, gender, American Society of Anesthesiologists classes (ASA), duration of exam, and sedative used for midazolam or/and propofol of 262 patients with sedated ERCP. The differences between categorical and continuous variables were analyzed using the Student's t test and the chi-square test. Desaturation (SpO 2  ≤ 90%) occurred in 9(3.4%) patients among 262 patients during sedated ERCP. The variables found to predict desaturation were older age (p < 0.01), higher sedation dose for midazolam or propofol (p < 0.01), and use of midazolam (p < 0.01). Desaturation rate was lower during sedated ERCP with HFNO compared to the preliminary study with conventional low flow nasal oxygen. Patients with older age, higher sedation dose, or the use of midazolam might require close monitoring for desaturation and hypoventilation by nursing staff. The study shows the use of high-flow nasal oxygen reduces the incidence of desaturation during ERCP.

Background/aims: Endoscopic retrograde cholangiopancreatography (ERCP) is used as a curative method for choledocholithiasis, but little is known about ERCP for patients with end-stage renal disease (ESRD) on hemodialysis (HD). The aim of the current study was to evaluate the efficacy and safety of ERCP for patients with ESRD on HD and to identify the risk factors of ERCP-related bleeding., Materials and Methods: The medical records of 61 ESRD patients with choledocholithiasis who underwent ERCP were retrospectively investigated with respect to successful bile duct stone removal and procedure-related adverse events such as pancreatitis, bleeding, and cholangitis., Results: For the study subjects, the overall stone removal success rate was 96.7%, and the overall ERCP-related adverse event rate was 21.3% (pancreatitis, 4.9%; bleeding, 13.1%; cholangitis, 6.6%). Endoscopic sphincterotomy (EST) was found to be associated with hemorrhage (p=0.02), and the occurrence of hemorrhage in patients who underwent EST with or without endoscopic papillary balloon dilation (EPBD) was significantly higher than that in patients who underwent EPBD alone (Odds ratio 1.27, 95% confidence interval 1.075-1.493, p=0.02)., Conclusion: ERCP for ESRD patients was found to be feasible and safe. However, EST was significantly related to hemorrhagic events. EPBD reduced the risk of hemorrhage and was as effective as EST in terms of stone removal.

Objectives: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP., Methods: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups., Results: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group., Discussion: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.

Background and Aim: Post endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis is not an uncommon adverse event but may not be avoidable. Various pharmacological and endoscopic techniques have been used to prevent post-ERCP pancreatitis (PEP), but most have been ineffective. The aim of this study was to evaluate the preventative effect of an intrapancreatic duct injection of nafamostat mesilate (NM) on PEP. Methods: This experimental study was conducted on 8 mini pigs. Animals were randomly allocated to a control group ( n  = 4) and or a NM group ( n  = 4). Pancreatitis was induced by infusing contrast medium into the main pancreatic duct by ERCP in all animals. After contrast medium injection, NM (50 mg/5 cc) was infused in the NM group and the same amount of 5% dextrose solution was infused in the control group. Twenty-four hours after endoscopic procedures, pancreatic inflammation, edema, vacuolization, necrosis and hemorrhage were evaluated histologically. Results: All animals survived until the end of the experiment. No peri-procedural technical difficulty or adverse event was encountered. Histologic examinations confirmed acute pancreatitis in all animals. In histologic acute pancreatitis scoring, no significant intergroup differences were observed between edema ( P  = 0.134), leukocyte infiltration ( P  = 0.356), vacuolization ( P  = 1.000), or hemorrhage ( P  = 0.071) scores. However, mean necrosis score was significantly lower in the NM group (1.0) than in controls (1.75, P  = 0.024). Conclusion: NM injection into the intrapancreatic duct produced promising results with respect to the prevention of PEP development, especially regarding the prevention of necrosis.

Background/aims: A reproducible, endoscope-based, large animal model, of acute pancreatitis was developed to meet the need for a suitable means of preclinically testing treatments. The aim of this study was to develop an endoscope-based animal model of acute pancreatitis., Methods: This experimental study was conducted on six mini-pigs. The pancreatitis model was induced by infusing contrast medium (CM) or sodium taurocholate (TCA) under high pressure (100 mmHg) into the main pancreatic duct by endoscopic retrograde pancreatography. Animals were randomly allocated to three groups: a CM group, a 10% TCA group, and a 20% TCA group. Pancreatic injuries were evaluated histologically, and serum amylase and lipase levels were measured., Results: Acute pancreatitis was observed in all animals during hematologic and histologic examinations. Serum amylase and lipase levels were significantly higher (> 10 times baseline), and pancreatic edema, vacuolization of acinar cells, and hemorrhagic necrosis were observed. Severity of pancreatitis tended to be greater in the TCA groups than in the CM group as assessed using histologic scores, and degrees of pancreatitis were found to be dose-dependently related to TCA concentration., Conclusion: The two endoscopic procedures described are effective and safe for creating a swine model of acute pancreatitis. The authors hope the described endoscopic methods will assist in the development of a suitable treatment strategy.

Background and Aim: Although endoscopic papillary large balloon dilation (EPLBD) has been widely used to facilitate the removal of difficult common bile duct stones, however, the outcomes have not yet been investigated in terms of the diameter of the balloon used. We aimed to compare the clinical outcomes between EPLBD using smaller (12-15 mm, S-EPLBD) and larger balloons (> 15 mm, L-EPLBD)., Methods: Six hundred seventy-two patients who underwent EPLBD with or without endoscopic sphincterotomy for common bile duct stone removal were enrolled from May 2004 to August 2014 at four tertiary referral centers in Korea. The outcomes, including the initial success rate, the success rate without endoscopic mechanical lithotripsy, the overall success rate, and adverse events between S-EPLBD and L-EPLBD groups, were retrospectively compared., Results: The initial success rate, the success rate without mechanical lithotripsy, the overall success rate, and the overall adverse events were not significantly different between the two groups. The rate of severe-to-fatal adverse events was higher in the L-EPBLD group than in the S-EPLBD group (1.6% vs 0.0%, 0.020). One case of severe bleeding and two cases of fatal perforation occurred only in the L-EPLBD group. In the multivariate analysis, the use of a > 15-mm balloon was the only significant risk factor for severe-to-fatal adverse events (>0.005, 23.8 [adjusted odds ratio], 2.6-214.4 [95% confidence interval])., Conclusions: L-EPLBD is significantly related to severe-to-fatal adverse events compared with S-EPLBD for common bile duct stone removal., (© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background: Endoscopic papillary large balloon dilation (EPLBD) without prior endoscopic sphincterotomy (EST) produces excellent outcomes for the treatment of large common bile duct (CBD) stones. However, it remains unclear how the outcomes of EPLBD alone compare with those of EPLBD with EST. In this study, we assessed the safety and therapeutic outcomes of EPLBD with vs. without EST for the removal of large bile duct stones., Methods: This prospective, multicenter study was conducted on 200 patients with bile duct stones of ≥ 10 mm in diameter. Patients were randomly assigned to an EPLBD alone group (n = 100) or an EPLBD with EST group (n = 100). These two groups were compared with respect to overall procedure-related adverse events, overall stone removal success rate, number of endoscopic sessions required for complete stone removal, need for mechanical lithotripsy, and total procedure time., Results: The incidence of adverse events was not significantly different between the groups (EPLBD alone vs. EPLBD with EST: overall adverse events 6 % vs. 4 %, P  = 0.75; pancreatitis 1 % vs. 3 %, P  = 0.62). Overall success ( P  = 0.35), initial success ( P  = 0.28), and the need for mechanical lithotripsy ( P  = 0.39) were also similar between groups. Median total procedure time tended to be greater in the EPLBD alone group (20.5 minutes) than in the EPLBD with EST group (18 minutes; P  = 0.08)., Conclusion: The therapeutic outcomes and adverse events of EPLBD alone for the removal of large bile duct stones were comparable to those of EPLBD with EST., Competing Interests: None, (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aim: Endoscopic access to the common bile duct remains difficult in 10% of cases undergoing endoscopic retrograde cholangiopancreatography (ERCP). In the current study, we evaluated the effectiveness of a stiff-shaft and flexible-tip guidewire (Visiglide2 ® ) for selective biliary access., Methods: We conducted a prospective, randomized controlled study in a single center involving patients with a naïve papilla who required biliary cannulation. We randomly allocated the patients to the Visiglide 2 group (group V) or to the conventional guidewire group (group C). Primary success rate of biliary cannulation, cannulation time, number of papillary attempts, number of pancreatic duct cannulations, total procedure time and final success rate were recorded during the endoscopic procedure., Results: Total of 100 patients were enrolled and assigned to groups V (n = 50) and C (n = 50). Primary selective biliary cannulation of group V tended to show a higher success rate than that of group C (group V, 96% (48/50); group C, 86% (43/50); P = 0.08). Final success rate for biliary cannulation was 100% in both groups. Mean times for biliary cannulation were 174.9 s for group V and 363.5 s for group C (P = 0.04). Number of papillary attempts for cannulation was significantly fewer in group V (1.84) than in group C (3.44; P < 0.01)., Conclusion: Use of Visiglide 2 guidewire might facilitate selective biliary cannulation compared to conventional guidewire in terms of reducing cannulation time and papilla attempts., (© 2017 Japan Gastroenterological Endoscopy Society.)

Background and Study Aim: Fully covered, self-expandable metal stents (FCSEMSs) are acceptable tools for treating benign biliary stricture (BBS). However, little is known about the long-term outcomes of this technique. The aim of the present study was to evaluate the procedural and long-term outcomes of FCSEMSs for treating BBSs., Patients and Methods: A total of 134 consecutive patients (median age 56 years; range 21 - 83) with BBS were retrospectively reviewed. The main outcomes were technical and clinical success, stricture resolution, recurrence, and adverse events. Outcomes were analyzed by reviewing patient medical records., Results: The success rates of FCSEMS placement and removal were 99.3 % and 98.2 %, respectively. Stricture resolution occurred in 103/132 (78.0 %) of the patients (median stent duration, 93 days; range 1 - 489). The associated factors for stricture resolution were longer stent indwelling period (≥ 120 days) and absence of stent migration. Stricture recurrence was seen in 26/103 patients (25.2 %; 95 % confidence interval [CI] 0.17 - 0.34) within a median of 390 days (range 4 - 903 days). Chronic pancreatitis was associated with stricture recurrence (hazard ratio [HR] 2.59, 95 %CI 1.20 - 5.61; P = 0.02). Stent migration occurred in 41/132 patients (31.1 %; 95 %CI 0.23 - 0.39). The FCSEMS with anchoring flaps appeared to protect against stent migration (HR 0.22, 95 %CI 0.08 - 0.63; P < 0.01)., Conclusion: FCSEMSs had a high success rate for BBS resolution. Longer indwelling periods and the absence of stent migration might be important factors for stricture resolution., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background/aim: Endoscopic treatment for removal of large or impacted bile duct stones is challenging, and may not be successful. The aim of this study was to evaluate the safety and efficacy of endoscopic balloon dilation lithotripsy (EBDL) as a means of treating difficult extrahepatic bile duct stones refractory to failed conventional endoscopic treatments., Patients and Methods: The patients were included in the indication of EBDL only if stones were confirmed as brown-pigmented stones or recurrent. Balloon dilation was performed using a balloon dilation catheter in order to crush large and/or impacted stones at the common hepatic duct or common bile duct level in seven cases, and then fragmented stones were removed using a basket and/or an extraction balloon catheter., Results: The median diameter of the balloons used for EBDL was 32.4 ± 10.5 mm (range, 12.4-52.1). Balloon dilation was performed for 60 s per session. The mean number of EBDL sessions required to crush stones was two (range, 1-5), the mean number of ERCP sessions required for complete stone removal was 2.4 ± 0.8 (range, 1-3), the overall procedure-related complication rate was 0% (0/7), and the success rate was 100% (7/7)., Conclusion: EBDL might be a safe and effective option for the treatment of large and impacted extrahepatic bile duct stones refractory to conventional endoscopic treatments.