Endoscopic sphincterotomy (EST), especially when anticoagulants are used, carries a significant risk of delayed bleeding. However, the relationship between the use of antithrombotic agents, including direct oral anticoagulants, and post-EST bleeding remains unclear. This study aimed to identify the risk factors for post-EST delayed bleeding when antithrombotic agents were administered according to the guidelines.

We analyzed cases of patients who underwent endoscopic retrograde cholangiopancreatography and EST between January 2018 and August 2022, focusing on those with normal anatomy and naïve papillae. We examined the incidence of post-EST bleeding, endoscopic retrograde cholangiopancreatography procedure details, severity and timing of post-EST delayed bleeding, hemostatic interventions, and factors related to post-EST delayed bleeding.

Among the 502 patients included, 76 (15%) were taking antithrombotic agents. Post-endoscopic retrograde cholangiopancreatography delayed bleeding was noted in seven patients (1.4%). Mild, moderate, and severe delayed bleeding occurred in four, one, and two cases, respectively. Hemostatic injection completely controlled cases of delayed bleeding. Multivariate analysis identified a 1-day direct oral anticoagulants interruption (odds ratio: 20.5, 95% confidence interval: 3.33-125, p = 0.0011) and dialysis (odds ratio: 38.7, 95% confidence interval: 2.4-624, p = 0.0099) as significant risk factors for delayed bleeding. No thromboembolic events related to the discontinuation of antithrombotic drugs were observed.

A 1-day direct oral anticoagulants interruption and dialysis are independent risk factors for post-EST delayed bleeding, necessitating careful consideration.

Acute pancreatitis, which sometimes results in mortality, is a significant complication of endoscopic retrograde cholangiopancreatography (ERCP). Many studies have been conducted to predict and prevent post-ERCP pancreatitis (PEP), and meta-analyses have been reported that summarized these studies. However, many issues remain unresolved. Many risk factors for PEP have been reported, and it is rare for patients undergoing ERCP to have only one risk factor. The use of artificial intelligence may be important for analyzing complex and diverse risk factors. It is desirable to develop an alternative test for pancreatic enzymes that can predict the onset of PEP within 1 h after ERCP. The effectiveness of low-dose nonsteroidal anti-inflammatory drugs (NSAIDs) are controversial. Nitrate and tacrolimus are considered medications that have additional effects on NSAIDs and may be used for the prevention of PEP. Pancreatic stent placement with deliberate placement of the guidewire into the pancreatic duct may be more effective in preventing PEP. A comparison between transpancreatic sphincterotomy with deliberate guidewire placement into the pancreatic duct and needle-knife precut sphincterotomy is necessary. Early precutting is thought to be effective for the prevention of PEP, and the effectiveness of primary precut has been reported. However, the optimal timing of precut for the prevention of PEP has not been sufficiently discussed. Further research on prediction and prevention must be conducted to eliminate the mortality caused by PEP.

This study aimed to determine the impact of the coronavirus disease 2019 (COVID-19) pandemic on the treatment of acute cholangitis caused by choledocholithiasis.

The Japanese government declared a state of emergency in April 2020 due to the COVID-19 pandemic. We retrospectively reviewed the medical records of 309 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for acute cholangitis caused by choledocholithiasis between April 2017 and December 2022.

Patients were categorized into a pregroup (n = 134) and a postgroup (n = 175), depending on whether they were diagnosed before or after the state of emergency declaration. The total number of ERCP cases and the number of ERCP cases with endoscopic stone removals increased after the state of emergency declaration. Compared with the pregroup, the numbers of patients with performance status of 0-1 and surgically altered anatomy increased, whereas the numbers of patients taking oral antiplatelets or anticoagulants and those with cerebrovascular disease decreased in the postgroup. The number of single-stage endoscopic stone removals increased and hospital stays were significantly shorter in the postgroup. No differences in adverse event rates were detected between the two groups.

Although our hospital provides tertiary care, the number of patients with cholangitis in good general condition and no underlying disease increased after the state of emergency declaration. The COVID-19 pandemic resulted in an increase in the number of single-stage endoscopic treatments and shortened hospital stays for patients with acute cholangitis caused by choledocholithiasis. No safety issues with ERCP were detected, even during the pandemic.

Early and effective management of choledocholithiasis is imperative to decrease patient morbidity. Despite the widespread use of ERCP, advancements in laparoscopy and choledochoscopy have renewed interest in laparoscopic CBD exploration (LCBDE). This meta-analysis compares outcomes of 2-stage ERCP followed by laparoscopic cholecystectomy (LC) versus one-stage transcystic LCBDE plus LC.

A comprehensive literature search was performed in PubMed, CENTRAL, and Embase databases according to PRISMA guidelines. Studies were selected based on specific criteria. Data on stone clearance, postoperative pancreatitis, bleeding, mortality, and length of stay were extracted.

Seven comparative non-randomized studies enrolling 669 "one-stage LCBDE patients" and 724 "two-stage ERCP patients" were included. Overall, there were no statistically significant differences regarding the rates of stone clearance, pancreatitis, bleeding, and mortality between the 2 groups.

One-stage transcystic LCBDE is noninferior to the 2-stage ERCP + LC approach, supporting its use as a first-line treatment for choledocholithiasis.

Recent meta-analyses suggested diclofenac may be superior to indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). The aim of our study was to compare the efficacy of 100 mg rectal indomethacin versus diclofenac on PEP incidences.

This multicentre, double-blinded, randomised controlled trial was conducted in nine tertiary centres in China. Patients with low and high risk for PEP and native papilla were randomly allocated (1:1) to receive 100 mg diclofenac or 100 mg indomethacin rectally before ERCP. The primary outcome was the occurrence of PEP defined by the Cotton consensus. The intention-to-treat principle was conducted for the analysis.

The trial was terminated early for futility after the predetermined first interim analysis. Between June 2023 and May 2024, 1204 patients were randomised into the diclofenac group (n=600) or indomethacin group (n=604). Baseline characteristics were balanced. The primary outcome occurred in 53 patients (8.8%) of 600 patients allocated to the diclofenac group and 37 patients (6.1%) of 604 patients allocated to the indomethacin group (relative risk 1.44; 95% CI 0.96 to 2.16, p=0.074). PEP occurred in 35 (14.2%) of 247 high-risk patients in the diclofenac group and 26 (9.8%) of 266 high-risk patients in the indomethacin group (p=0.124). PEP incidences were also comparable in low-risk patients between the two groups (18/353 (5.1%) vs 11/338 (3.3%), p=0.227). Other ERCP-related complications did not differ between the two groups.

Pre-procedure 100 mg rectal diclofenac was not superior to the same dose of rectal indomethacin regarding preventing PEP. These findings supported current clinical practice guidelines of 100 mg indomethacin or diclofenac for PEP prophylaxis in patients without contraindications.

ClinicalTrials.gov (NCT05947461).

Delayed bleeding after endoscopic sphincterotomy (EST) constitutes a significant adverse event, occurring in ~0.5-5% of patients. The number of patients receiving anticoagulants to prevent cardiovascular and cerebrovascular disease has increased with the aging society worldwide; however, anticoagulants (direct oral anticoagulants [DOACs] and warfarin) are one of the most major risk factors for postprocedure bleeding. This review investigated post-EST bleeding in anticoagulant users, focusing on risk factors, clinical guidelines, pharmacological characteristics, and the future of post-EST bleeding. Several clinical guidelines for antithrombotic drug users have been established to prevent postprocedure bleeding; nevertheless, the risk of bleeding is believed to be several times higher than for nondrug users, regardless of clinical guideline compliance. The major problem in this field is that patients who experience delayed bleeding are often receiving multiple antithrombotic drugs, and no parameters that can accurately monitor the anticoagulant effect of DOACs have been identified. Therefore, identifying patients with a generally high-risk of postprocedure bleeding is crucial. Recently, the plasma level and antifactor Xa activity of factor Xa inhibitors have been investigated in relation to the risk of major bleeding in users. Similar to the prothrombin time-international normalized ratio for warfarin, plasma levels, and antifactor Xa activity may be useful parameters for monitoring the anticoagulant effect and identifying DOAC users at higher risk of postprocedure bleeding, including post-EST bleeding. Future studies should stratify the risk of post-EST delayed bleeding based on a scoring system to prevent this complication.

Laparoscopic transcystic bile duct exploration (LTCBDE) represents a secure and efficacious approach for managing common bile duct (CBD) stones, particularly in patients concurrently undergoing laparoscopic cholecystectomy (LC). The decision to proceed with LTCBDE hinges on real-time assessment of the intraoperative cholangiogram (IOC), which is highly operator-dependent and poorly interpreted. No established criteria exist to guide the evaluation of IOCs for LTCBDE. This study aims to ascertain the concordance among surgeons, experienced in LTCBDE, on critical aspects of IOC interpretation.

A retrospective collection of IOC images of 40 patients who underwent LC, IOC, and LTCBDE at a tertiary university hospital between 2017 and 2018 was undertaken. Two hepato-pancreato-biliary (HPB) and 2 acute care surgery (ACS) specialists independently reviewed the images. They were tasked with assessing IOC features hypothesized to influence duct exploration and stone extraction complexity, along with overall suitability for LTCBDE based exclusively on the IOC images. Agreement percentages were calculated and Kappa inter-rater reliability statistics were assessed.

The overall agreement percentages concerning IOC features ranged between 52.5% and 82.5% with agreements surpassing 75% deemed robust. Maximum agreement was achieved in the interpretation of cystic duct morphology, whether straight or characterized by spiral valves. The concurrence for amenability of LTCBDE also demonstrated substantial accord among surgeons (ACS: 92.5%, HPB: 95%, total: 87.5%). Consistently high agreement was evident within specialty groups.

Anatomical attributes displayed superior agreement levels, as opposed to variables necessitating measurements. We recommend the development of a structured approach for the interpretation of IOC to facilitate surgical education in LTCBDE.

Laparoscopic cholecystectomy is the preferred treatment for symptomatic cholelithiasis and acute cholecystitis, with increasing applications even in severe cases. However, the possibility of postoperative endoscopic retrograde cholangiopancreatography (ERCP) to manage choledocholithiasis or biliary injuries poses significant clinical challenges. This study aimed to develop a predictive model for ERCP incidence following emergency laparoscopic cholecystectomy using advanced machine learning techniques.

We conducted a retrospective cohort study using the Tokushukai Medical Database, which includes data from 42 hospitals. The study population consisted of adult patients undergoing emergency laparoscopic cholecystectomy. We used four machine learning models-logistic regression, random forest, gradient-boosting decision trees (GBDTs), and multilayer perceptrons on a dataset divided into training/validation and testing groups. We also calculated Shapley additive explanation values for GBDTs to identify variables with larger feature importance.

Of 9,695 patients from July 2010 to June 2020, 8,854 met the inclusion criteria. The incidence of postoperative ERCP was 5.7% (362/6,377) and 6.4% (158/2477) in the training/validation and testing datasets, respectively. The GBDT demonstrated superior performance, with the highest predictive capacity for postoperative ERCP. Significant predictors identified included common bile duct dilatation on CT or ultrasound, serum albumin, and lactate dehydrogenase levels, which showed larger feature importance.

This study successfully developed a robust predictive model for ERCP following emergency laparoscopic cholecystectomy.

Endoscopic retrograde cholangiopancreatography (ERCP)-related adverse events (AEs) are associated with morbidity, mortality, and health care expenditure. We aimed to assess incidences and comparisons of ERCP AEs.

We included studies performed after 2000 reporting on ERCP AEs from database inception through March 12, 2024. Outcomes included pancreatitis, bleeding, cholangitis, cholecystitis, perforation, and death. DerSimonian and Laird random effects meta-analyses were performed to calculate incidences of AEs. Subgroup and pairwise meta-analyses were performed. Meta-regression was performed on median recruitment year to assess temporal trends in pancreatitis incidence.

A total of 380 studies were included. The incidence of death attributable to ERCP was 0.2% (95% confidence interval [CI], 0.1%-0.3%; I2, 44%; n = 47,258) in all-comers. The overall incidence of pancreatitis was 4.6% (95% CI, 4.0%-5.1%; I2, 96%; n = 293,378) among all-comers and 6.5% (95% CI, 5.9%-7.1%, I2, 89%; n = 88,809) among first-time patients. Pancreatitis incidence remained stable between 2000 and 2023 (average annual percent change 0.06, 95% CI, -0.27 to 0.39). The overall incidences of the following AEs for all-comers were: bleeding (1.5%; 95% CI, 1.2%-1.7%; I2, 93%; n = 229,655), cholangitis (2.5%; 95% CI, 1.9%-3.3%; I2, 96%; n = 121,619), cholecystitis (0.8%; 95% CI, 0.5%-1.2%; I2, 39%; n = 7799), and perforation (0.5%; 95% CI, 0.4%-0.6%; I2, 90%; n = 306,378).

ERCP-associated AEs remain common. Incidence of post-ERCP pancreatitis remained static despite improvements in techniques, prevention, and recognition. These results are important to patients, endoscopists, and policy makers to inform consent and to encourage implementation of available risk mitigation strategies.

Difficult biliary cannulation (DBC) is a known risk factor for developing post-ERCP pancreatitis (PEP). To better understand how DBC increases PEP risk, we examined the interplay between technical aspects of DBC and known PEP risk factors.

This was a secondary analysis of a multicenter, randomized controlled trial comparing rectal indomethacin alone with the combination of rectal indomethacin and prophylactic pancreatic duct (PD) stent placement for PEP prophylaxis in high-risk patients. Participants were categorized into 3 groups: DBC with high preprocedure risk for PEP, DBC without high preprocedure risk for PEP, and non-DBC at high preprocedure risk for PEP.

In all, 1601 participants (84.1%) experienced DBC, which required a mean of 12 cannulation attempts (standard deviation, 10) and mean duration of 14.7 minutes (standard deviation, 14.9). PEP rate was highest (20.7%) in DBC with a high preprocedure risk, followed by non-DBC with a high preprocedure risk (13.5%), and then DBC without a high preprocedure risk (8.8%). Increasing number of PD wire passages (adjusted odds ratio [aOR], 1.97; 95% confidence interval [CI], 1.25-3.1) was associated with PEP in DBC, but PD injection, pancreatic sphincterotomy, and number of cannulation attempts were not associated with PEP. Combining indomethacin with PD stent placement lowered the risk of PEP (aOR, .61; 95% CI, .44-.84) in DBCs. This protective effect was evident in up to at least 4 PD wire passages.

DBC confers higher PEP risk in an additive fashion to preprocedural risk factors. PD wire passages appear to add the greatest PEP risk in DBCs, but combining indomethacin with PD stent placement reduces this risk, even with increasing PD wire passages.

Although endoscopic retrograde cholangiopancreatography (ERCP) has been shown to be a safe and effective approach in treating these diseases while carrying lower morbidity than traditional surgical treatments, ERCP has associated risks, with post-ERCP pancreatitis (PEP) being the most common serious adverse event and carries significant morbidity and health care cost. PEP results from multifactorial factors involving trauma to the pancreatic duct and papilla, leading to subsequent obstruction and impairment of pancreatic drainage. Important risk factors for PEP include history of prior PEP, suspected sphincter of Oddi dysfunction, difficult cannulation, pancreatic duct contrast injections, and pancreatic sphincterotomy.

Unresectable malignant bile duct stricture (often caused by unresectable pancreatic cancer and cholangiocarcinoma) can be drained via insertion of self-expandable metal stents (SEMS) during endoscopic retrograde cholangiopancreatography (ERCP). Because recurrent biliary obstruction (RBO) and complications following stent insertion can delay chemotherapy and other treatments, a longer time to RBO (TRBO) is desirable. Although a longer TRBO has been reported among patients who undergo insertion with larger diameter SEMS, patients who undergo insertion with smaller diameter fully covered SEMS (FCSEMS) may have a lower incidence of complications than those with larger diameter FCSEMS. The aim of this study is to determine the TRBO and incidence of complications with 6-mm FCSEMS vs 10-mm FCSEMS in patients with unresectable malignant distal bile duct stricture.

In this multicenter, open-label, randomized controlled, non-inferiority trial (COSMIC UNISON), a target of 250 patients over 23 locations in Japan will receive either the 6-mm FCSEM or the standard 10-mm FCSEM during ERCP, with 125 patients in each group. The observation period will be 24 months, and patients will be enrolled from 15 March 2024 and assessed until the date of RBO or the study end (31 March 2029). The primary endpoint is TRBO, with RBO defined as the coexistence of abnormal liver enzyme values and dilation of the common bile duct and intrahepatic bile duct upstream of the stent. The secondary endpoints are the incidence and rates (at 3, 6, and 12 months) of non-RBO events, overall survival, cause of RBO, and symptomatic stent deviation. Adverse events from endoscopic procedures will be classified by the Lexicon Classification from the American Society of Endoscopy, and all other adverse events will be classified per the Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0.

The COSMIC UNISON study is anticipated to provide evidence regarding the efficacy and safety of 6-mm vs 10-mm FCSEMS to inform the use of 6-mm FCSEMS for the treatment of unresectable malignant distal bile duct stricture.

Japan Registry of Clinical Trials identifier: jRCT1042230170. Prospectively registered on 15 March 2024.

Acute pancreatitis is a frequent, burdensome adverse event of endoscopic retrograde cholangiography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (NSAIDs) have reduced post-ERCP pancreatitis (PEP) risk by about 50 % and show greater efficacy over parenteral or oral administration, although the mechanism for its superiority remains unclear. To probe this question, we investigated in a preclinical model, the pharmacokinetics in the blood, pancreas and other tissues of the NSAID diclofenac given via the rectal, intravenous, or intragastric routes.

The data on diclofenac was extracted from a larger study that examined a combination of diclofenac and tacrolimus. 20.8 mg diclofenac/kg body weight, which is the mouse equivalent dosing used in clinical practice for PEP prophylaxis, was administered to C57BL/6J mice via the rectal, intravenous and intragastric (oral) routes. Cross-collection of blood and tissues was done at various timepoints after administration for the evaluation of drug levels and pharmacokinetic parameters.

Rectal diclofenac demonstrated favorable blood pharmacokinetics and systemic bioavailability as well as sustained pancreas penetration. The total pancreas exposure to diclofenac over 24 h following rectal dosing was not significantly different as compared to intravenous and oral dosing.

Our findings suggest that the efficacy of rectal diclofenac in PEP prevention relates more to its higher and consistent systemic exposure than its absolute pancreas levels. The implications are that the rectal route provides both systemic and pancreas exposure for the full duration of PEP vulnerability.

Endoscopic and laparoscopic techniques are crucial for management of bile duct stone.

The aim of this study was to share our initial experiences with endoscopic and laparoscopic treatments for recurrent choledocholithiasis, with a particular focus on long-term complications.

From January 2014 to June 2017, a total of 153 patients with recurrent common bile duct stones were prospectively recruited in this study. Patients were scheduled for either an endoscopic procedure (ERCP/EST group, n = 84), or a laparoscopic procedure (LCBDE group, n = 69). Data were collected on comorbid conditions, presenting symptoms, bile duct clearance, and the incidence of both short-term and long-term complications.

Patients in ERCP/EST group had a stone clearance rate comparable to that of the LCBDE group (94.2% vs 91.7%, p = 0.549). Minor (Clavien-Dindo grade 1 and 2) and major short-term complications (Clavien-Dindo grade 3 and above) were similar between patients in two groups (ERCP/EST group 17.9% versus LCBDE group 26.1%, and ERCP/EST group 7.1% versus LCBDE group 5.8%, p = 0.227 and p = 0.740, respectively). Patients in the ERCP/EST group had a shorter stone free interval than patients in the LCBDE group (28.5 ± 14.7 months versus 43.3 ± 17.8 months, p = 0.029). During a mean follow-up period of 67.0 months, more patients in the ERCP/EST group experienced stone recurrence compared to those in the LCBDE group (26.1% vs 11.6%, p = 0.020). In the ERCP/EST group, 45.5% (10/22) of the recurrent cases experienced more than two recurrences, with three patients requiring choledochojejunostomy due to repeated recurrence. Among patients with a non-dilated common bile duct (d ≤ 8 mm), both groups had comparable short-term and long-term complication rates (p = 0.151 and p = 0.404, respectively).

Laparoscopic treatment is a safe and effective option for patients with recurrent choledocholithiasis, extending the stone free interval, reducing the likelihood of stone recurrence, and highlighting benefits of minimally invasive surgery.

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a severe and deadly adverse event following ERCP. The ideal method for predicting PEP risk before ERCP has yet to be identified. We aimed to establish a simple PEP risk score model (SuPER model: Support for PEP Reduction) that can be applied before ERCP.

This multicenter study enrolled 2074 patients who underwent ERCP. Among them, 1037 patients each were randomly assigned to the development and validation cohorts. In the development cohort, the risk score model for predicting PEP was established via logistic regression analysis. In the validation cohort, the performance of the model was assessed.

In the development cohort, five PEP risk factors that could be identified before ERCP were extracted and assigned weights according to their respective regression coefficients: -2 points for pancreatic calcification, 1 point for female sex, and 2 points for intraductal papillary mucinous neoplasm, a native papilla of Vater, or the pancreatic duct procedures (treated as 'planned pancreatic duct procedures' for calculating the score before ERCP). The PEP occurrence rate was 0% among low-risk patients (≤0 points), 5.5% among moderate-risk patients (1-3 points), and 20.2% among high-risk patients (4-7 points). In the validation cohort, the C statistic of the risk score model was 0.71 (95% CI 0.64-0.78), which was considered acceptable. The PEP risk classification (low, moderate, and high) was a significant predictive factor for PEP that was independent of intraprocedural PEP risk factors (precut sphincterotomy and inadvertent pancreatic duct cannulation) (OR 4.2, 95% CI 2.8-6.3; p<0.01).

The PEP risk score allows an estimation of the risk of PEP prior to ERCP, regardless of whether the patient has undergone pancreatic duct procedures. This simple risk model, consisting of only five items, may aid in predicting and explaining the risk of PEP before ERCP and in preventing PEP by allowing selection of the appropriate expert endoscopist and useful PEP prophylaxes.

No external funding was received for this work.

Pancreatitis is the most common serious adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). This meta-analysis aimed to precisely assess the risk factors for post-ERCP pancreatitis (PEP).

We searched electronic databases for studies that assessed risk factors for PEP after adjusting for ≥3 risk factors, including at least one pre-specified patient-related and one procedure-related risk factor, and reported the data as adjusted odds ratios (ORs) with 95% confidence intervals. Meta-analyses were conducted using a random-effects model, and pooled adjusted ORs for risk factors reported in ≥3 studies were constructed.

A total of 159 studies with 315,580 ERCPs were included, assessing 31 unique risk factors (20 patient-related and 11 procedure-related). Key patient-related predictors of PEP were age ≤60 years (OR, 1.81; high credibility), prior acute pancreatitis (OR, 2.59; moderate), age ≤40 years (OR, 2.33; moderate), asymptomatic choledocholithiasis (OR, 4.76; low), prior PEP (OR, 4.40; low), sphincter of Oddi dysfunction (OR, 3.11; low), and female gender (OR, 1.70; low). Key procedure-related predictors of PEP were any guidewire passage into the pancreatic duct (PD) (OR, 2.18; high), first ERCP with a native papilla (OR, 1.91; high), endoscopic papillary balloon dilation of an intact papilla (OR, 2.91; moderate), pancreatic acinarization (OR, 4.23; low), any PD cannulation (OR, 2.73; low), pancreatic sphincterotomy (OR, 2.64; low), difficult cannulation (OR, 2.60; low), any pancreatogram (OR, 2.40; low), and precut sphincterotomy (OR, 1.98; low).

Our meta-analysis focused on adjusted risk factors to provide precise estimates of the most important risk factors for PEP. Incorporating our results into a prediction model may reliably help identify high-risk patients, optimize informed consent, and guide prevention and management strategies for PEP.

Background: Ursodeoxycholic acid (UDCA), chenodeoxycholic acid (CDCA) plus UDCA (C&U), and terpene are widely administered to prevent common bile duct (CBD) stone recurrence and dissolve gallbladder (GB) stones. We evaluated and compared the combined effects of these agents on CBD stone recurrence and GB stone resolution. Methods: This study included patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) at six referral centers, retrospectively. A total of 940 patients who underwent cholecystectomy before or after CBD stone removal by ERCP were evaluated to assess CBD stone recurrence (the CBD recurrence cohort), and 98 patients with GB stones were assessed by abdominal or endoscopic ultrasonography before and 6 months after ERCP to evaluate GB stone resolution (GB cohort). Patients were divided into no-medication, single-agent treatment (UDCA, C&U, or terpene), or dual-agent treatment (terpene plus UDCA or C&U) groups for the analysis. Results: In the CBD recurrence cohort, baseline characteristics were similar in the three groups. CBD stone recurrence rates were 41.5%, 12.7%, and 9.8% in the no-medication, single-agent, and dual-agent groups, respectively (p < 0.001), and the recurrence rate was significantly lower for those administered C&U plus terpene (5.2% vs. 13.2%, p = 0.002). In the GB cohort, baseline characteristics were also similar in the groups. GB stone resolution rates of >30% were observed in 5.3%, 14.3%, and 34.8% of patients in the no-medication, single-agent, and dual-agent groups, respectively (p = 0.028). Conclusions: C&U plus terpene was significantly more effective for preventing CBD stone recurrence and achieving GB stone resolution than no medication or single agents.

Serum amylase (AMY) levels measured 2-6 h after ERCP are a predictor of post-ERCP pancreatitis (PEP). Trypsin is one of the pancreatic enzymes elevated in the development of PEP. The study assessed whether serum trypsin (TRY) can predict early-stage PEP.

This prospective study included patients who underwent ERCP from June 2022 to May 2023. TRY, AMY, serum pancreatic AMY (P-AMY), and serum lipase (LIP) levels were measured immediately after ERCP and 2 h later. The primary outcome was the diagnostic abilities of TRY levels measured immediately (0 h-TRY) and 2 h after (2 h-TRY) ERCP to predict PEP (compared with the other serum pancreatic enzymes).

Of 130 patients analyzed, 18 developed PEP. The sensitivity and specificity of 0 h-TRY were 83.3% and 69.6%, respectively, and those of 2 h-TRY were 88.9% and 72.3%, respectively. The area under the curve (AUC) for 0 h-TRY was significantly higher than that for 0 h-AMY (p = .006) and 0 h-P-AMY (p = .012), whereas the AUCs for 0 h-TRY and 0 h-LIP did not differ significantly (p = .563). The AUC for 2 h-TRY for predicting PEP was significantly higher than that for 2 h-AMY (p = .025), whereas there was no significant differences between the AUCs for 2 h-TRY and 2 h-P-AMY(p = .146), or between those for 2 h-TRY and 2 h-LIP (p = .792). The median increase ratio (expressed as a ratio relative to baseline) in TRY was highest among all of serum pancreatic enzymes tested immediately after ERCP (5.35, 1.72, 1.94, and 4.44 for TRY, AMY, P-AMY, and LIP, respectively).

Measuring TRY immediately after ERCP is useful for the early prediction of PEP.

Difficult biliary cannulation is an independent risk factor for post-ERCP pancreatitis (PEP); however, there is a noticeable lack of studies focusing on the incidence and risk factors of PEP among patients undergoing easy cannulation. Therefore, we systematically investigated the risk factors for PEP in patients who underwent easy cannulation.

We prospectively enrolled patients with naive major papillae who underwent diagnostic or therapeutic ERCP between June 2018 and June 2023. The primary endpoint was to determine the incidence of PEP in patients with easy cannulation; secondary endpoints were identifying PEP risk factors and evaluating procedure-related adverse events (AEs).

Overall, 1930 patients were included, with 1061 (54.9%) undergoing easy cannulation. Within this cohort, PEP incidence was 3.0%, whereas 2.9% experienced procedure-related AEs, excluding PEP. A history of acute pancreatitis (odds ratio [OR], 6.75; 95% confidence interval [CI], 1.83-20.14; P = .001) and acute cholangitis on admission (OR, 2.25; 95% CI, 1.07-5.08; P = .039) were identified as independent risk factors for PEP in patients with easy cannulation. Endoscopic sphincterotomy and biliary stent placement were independent factors for procedure-related AEs.

Our findings underscore the importance of assessing patient- and procedure-related factors to mitigate the risk of PEP in patients undergoing easy cannulation. Despite the low incidence of PEP, the potential for the occurrence of severe cases emphasizes the need for cautious intervention, particularly in patients with a history of acute pancreatitis and acute cholangitis on admission. (Clinical trial registration number: KCT0005950.).

Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors of and outcomes after CSPEB.

We analyzed multicenter prospective ERCP data between 2018 and 2024 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in (i) hemoglobin drop ≥ 20 g/L or transfusion and/or (ii) endoscopy to evaluate suspected bleeding and/or (iii) unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was used. P values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported.

CSPEB occurred after 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring after higher risk interventions (sphincterotomy, sphincteroplasty, precut sphincterotomy, and/or needle-knife access). Patients with CSPEB required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with 3 cases (2.3%) being fatal. P2Y 12 inhibitors were held for a median of 4 days (interquartile range 4) before higher risk ERCP. After higher risk interventions, P2Y 12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24), and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding after sphincterotomy (OR 2.32, 1.06-4.60), but not after sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days after CSPEB (OR 12.71, 4.75-32.54).

Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets.

Delayed endoscopic sphincterotomy-related bleeding (ES bleeding) is an unavoidable adverse event (AE) that can have serious ramifications. Intraoperative ES bleeding, which stops spontaneously in most cases, is a known risk factor for delayed bleeding. This study aimed to examine the preventive effect of a novel self-assembling peptide (SAP) for delayed ES bleeding in patients who attained spontaneous hemostasis after intraoperative ES bleeding.

A total of 1507 patients met the eligibility criteria for inclusion in this study. The rates of delayed ES bleeding and AE besides bleeding were compared between patients administered the SAP (SAP group) and those who were simply observed after spontaneous hemostasis of intraoperative ES bleeding (control group). Propensity score matching was performed to adjust for differences between the groups.

The rate of delayed ES bleeding was significantly lower in the SAP group than that in the control group (0.9% vs 3.8%, P = 0.044). The rates of AEs other than bleeding were 2.4% and 3.8% in the SAP and control groups, respectively, and the difference lacked statistical significance (P = 0.481). Multivariate analysis revealed that the use of SAP was significantly associated with a lower frequency of delayed ES bleeding (odds ratio, 0.35; 95% confidence interval, 0.13-0.98; P = 0.047).

Self-assembling peptide may be a simple, safe, and useful way to reduce the risk of delayed ES bleeding in patients who experienced intraoperative ES bleeding and obtained subsequent spontaneous hemostasis.

The standard salvage technique used for difficult bile duct cannulation is precut sphincterotomy, whereas endoscopic ultrasound-guided rendezvous technique (EUS-RV) is a relatively newer method. Prospective comparative data between these 2 techniques as salvage for biliary access in patients with benign biliary disease and difficult bile duct cannulation is lacking.

To compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction.

Participant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613).

Tertiary care academic institute from July 2020 to May 2021.

All patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy.

Patients were randomly assigned by computer-generated randomized blocks sequence in 1:1 fashion to either EUS-RV or precut sphincterotomy. Patients with failure in EUS-RV were crossed over to precut sphincterotomy and vice versa.

The primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events.

In total, 100 patients were randomly assigned to EUS-RV (n = 50) and precut sphincterotomy (n = 50). The technical success rate (92% vs. 90%; P = 1.00; relative risk, 1.02 [95% CI, 0.90 to 1.16]), median procedure time (10.1 vs. 9.75 minutes), and overall complication rate (12% vs. 10%; relative risk, 1.20 [CI, 0.39 to 3.68]) were similar between the 2 groups. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. All failed cases in either salvage group could be successfully cannulated when crossed over to the other group.

Single center study done by experts.

Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy have similar success rates as salvage techniques in the technically challenging cohort of difficult bile duct cannulation for benign biliary disease, with acceptable complications rates.

None.

We aimed to assess the hospital frailty risk score on the inpatient mortality, morbidity, and health care resource utilization among endoscopic retrograde cholangiopancreatography (ERCP)-related hospitalizations.

Data regarding the inpatient mortality, morbidity, and health care resource utilization of ERCP among frail individuals remain limited.

Using the Nationwide Inpatient Sample, we compared the odds of inpatient mortality and morbidity of ERCP-related hospitalizations among individuals with low frailty scores, intermediate frailty scores (IFSs), and high frailty scores (HFSs).

Overall, 776,025 ERCP-related hospitalizations were recorded from 2016 to 2020. 552,045 had a low frailty score, whereas 217,875 had an IFS, and 6105 had an HFS. Frail individuals had a 5-fold increase in mortality [IFS: adjusted odds ratio (aOR) = 4.81, 95% CI: 3.77-6.14; HFS: aOR = 4.62, 95% CI: 2.48-8.63]. An IFS was associated with a 24% increase in post-ERCP pancreatitis (aOR = 1.25, 95% CI: 1.11-1.41), a 3-fold increase in post-ERCP bleeding (aOR = 2.59, 95% CI: 1.82-3.67), and a 2-fold increase in post-ERCP duct perforation (aOR = 1.91, 95% CI: 1.38-2.64). Frail individuals experienced higher odds of in-hospital morbidity, including secondary sepsis, respiratory failure, acute kidney injury, cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.

In summary, our study presents strong evidence in support of using the hospital frailty risk score as an index to predict mortality and morbidity during ERCP-related hospitalizations. Additional caution is warranted in the management of frail individuals undergoing ERCP.

Endoscopic retrograde cholangiopancreatography (ERCP) is associated with a variety of adverse events (AEs). One of the most important AEs is post-ERCP pancreatitis (PEP), which is most common in cases of difficult biliary cannulation. Although the precut technique has been reported as a PEP risk factor, recent studies indicate that early precut could reduce PEP, and that precut itself is not a risk factor.

To evaluate the safety of the precut technique, especially in terms of PEP.

We conducted a retrospective study, spanning the period from November 2011 through December 2021. It included 1556 patients, aged ≥ 20 years, who underwent their initial ERCP attempt for biliary disease with a naïve papilla at the Kawasaki University General Medical Center. We compared the PEP risk between the early precut and the delayed precut group.

The PEP incidence rate did not significantly differ between the precut and non-precut groups. However, the PEP incidence was significantly lower in the early precut group than the delayed precut group (3.5% vs 10.5%; P = 0.02). The PEP incidence in the delayed precut group without pancreatic stent insertion (17.3%) was significantly higher compared to other cases (P < 0.01).

Our findings indicate that early precut may reduce PEP incidence. If the precut decision is delayed, a pancreatic stent should be inserted to prevent PEP.

Severity of microlithiasis- and sludge-induced pancreatitis in comparison to gallstone-induced pancreatitis has never been studied for a lack of definition.

In this retrospective cohort study, 263 patients with acute biliary pancreatitis treated at a tertiary care center from 2005 to 2021 were stratified according to the recent consensus definition for microlithiasis and sludge. The gallstone-pancreatitis cohort was compared to microlithiasis, sludge, and suspected stone passage pancreatitis cohorts in terms of pancreatitis outcome, liver function, and endosonography/endoscopic retrograde cholangiopancreatography results using one-way analysis of variance and χ 2 test. Multinomial logistic regression analysis was performed to correct for bias.

Microlithiasis- and sludge-induced pancreatitis, classified according to the revised Atlanta classification, did not present with a milder course than gallstone-induced pancreatitis ( P = 0.62). Microlithiasis and sludge showed an increase in bilirubin on the day of admission to hospital, which was not significantly different from gallstone-induced pancreatitis ( P = 0.36). The likelihood of detecting biliary disease on endosonography resulting in bile duct clearance was highest on the day of admission and day 1, respectively.

Microlithiasis and sludge induce gallstone-equivalent impaired liver function tests and induce pancreatitis with similar severity compared with gallstone-induced acute biliary pancreatitis.

Endoscopic sphincterotomy (ES) is not mandatory before biliary stenting. The impact of ES before biliary stent placement remains uncertain. Previous studies have reported that ES can increase adverse event rates by up to 4.5 times compared with no ES. We aimed to assess the occurrence of post-ERCP adverse events following biliary stent placement with and without ES.

PubMed, Embase, and Cochrane databases were systematically searched for randomized controlled trials. The primary outcome was post-ERCP pancreatitis (PEP). Subgroup analyses were performed with patients undergoing biliary drainage due to obstruction, using metal stents, and using plastic stents. Secondary outcomes were postprocedural bleeding, perforation, stent/catheter occlusion, stent/catheter migration, and cholangitis. Heterogeneity was examined with I2 statistics, and a random-effects model was used. Review Manager 5.4 was used for statistical analyses.

Seven RCTs with 1022 patients were included. There was no significant difference between the ES and non-ES groups (odds ratio [OR], .46; 95% CI, .19-1.09; P = .08; I2 = 59%) regarding PEP; however, a significant difference in bleeding rates was found between groups, favoring non-ES (OR, 7.01; 95% CI, 2.24-21.99; P = .0008; I2 = 0%). The analysis of the occurrence of cholangitis (OR, 1.25; 95% CI, .58-2.69; P = .56; I2 = 67%), perforation (OR, 1.95; 95% CI, .07-55.73; P = .70; I2 = 58%), stent/catheter migration (OR, 2.15; 95% CI, .61-7.57; P = 0.23; I2 = 6%), and stent/catheter occlusion (OR, .91; 95% CI, .37-2.25; P = .84; I2 = 0%) did not favor either group.

Performing ES before biliary drainage does not affect the PEP rate but is associated with an increased postprocedural bleeding rate.

Greater availability of less invasive biliary imaging to rule out choledocholithiasis should reduce the need for diagnostic endoscopic retrograde cholangiopancreatography (ERCP) in patients who have a remote history of cholecystectomy. The primary aims were to determine the incidence, characteristics, and outcomes of individuals who undergo first-time ERCP >1 year after cholecystectomy (late-ERCP).

Data from a commercial insurance claim database (Optum Clinformatics) identified 583,712 adults who underwent cholecystectomy, 4274 of whom underwent late-ERCP, defined as first-time ERCP for nonmalignant indications >1 year after cholecystectomy. Outcomes were exposure and temporal trends in late-ERCP, biliary imaging utilization, and post-ERCP outcomes. Multivariable logistic regression was used to examine patient characteristics associated with undergoing late-ERCP.

Despite a temporal increase in the use of noninvasive biliary imaging (35.9% in 2004 to 65.6% in 2021; P < .001), the rate of late-ERCP increased 8-fold (0.5-4.2/1000 person-years from 2005 to 2021; P < .001). Although only 44% of patients who underwent late-ERCP had gallstone removal, there were high rates of post-ERCP pancreatitis (7.1%), hospitalization (13.1%), and new chronic opioid use (9.7%). Factors associated with late-ERCP included concomitant disorder of gut-brain interaction (odds ratio [OR], 6.48; 95% confidence interval [CI], 5.88-6.91) and metabolic dysfunction steatotic liver disease (OR, 3.27; 95% CI, 2.79-3.55) along with use of anxiolytic (OR, 3.45; 95% CI, 3.19-3.58), antispasmodic (OR, 1.60; 95% CI, 1.53-1.72), and chronic opioids (OR, 6.24; 95% CI, 5.79-6.52).

The rate of late-ERCP postcholecystectomy is increasing significantly, particularly in patients with comorbidities associated with disorder of gut-brain interaction and mimickers of choledocholithiasis. Late-ERCPs are associated with disproportionately higher rates of adverse events, including initiation of chronic opioid use.

Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are said to be useful procedures for gallstone pancreatitis. However, there have been few reports on a large number of patients to whom they were used. The clinical usefulness of ERCP and EST is herein examined retrospectively.

ERCP and EST were performed to evaluate their clinical usefulness and safety in 108 patients who had gallbladder stones from December 1985 to October 2017 and were diagnosed as having gallstone pancreatitis. Of 108 patients, 83 were mild, and 25 were severe. Following the procedures, clinical courses were observed for three years in 108 patients who underwent the treatments.

Cholangiogram was successfully conducted in 108 patients. Bile duct stones were noted in 90 patients, and the stones were removed after EST. Of 18 patients who did not show bile duct stone in cholangiogram, 13 patients underwent EST, while five patients taking anticoagulants completed procedures only with cholangiogram. Accidental symptom was hemorrhage in three patients (2.7%; 3/108), but it was mild and conservatively resolving. During the three-year observation period, acute cholangitis was noted in three patients (2.7%; 3/108), but no relapsing pancreatitis was noted.

It was suggested that ERCP and EST could be useful therapies for gallstone pancreatitis.

The increased incidence of gallstones can be linked to previous gastrectomy (PG). However, the success rate of endoscopic retrograde cholangiopan-creatography after gastrectomy has significantly reduced. In such cases, laparoscopic transcystic common bile duct exploration (LTCBDE) may be an alternative. In this study, LTCBDE was evaluated for its safety and feasibility in patients with PG. We retrospectively evaluated 300 patients who underwent LTCBDE between January 2015 and June 2023. The subjects were divided into 2 groups according to their PG status: PG group and No-PG group. The perioperative data from the 2 groups were compared. The operation time in the PG group was longer than that in the No-PG group (184.69 ± 20.28 minutes vs 152.19 ± 26.37 minutes, P < .01). There was no significant difference in intraoperative blood loss (61.19 ± 41.65 mL vs 50.83 ± 30.47 mL, P = .087), postoperative hospital stay (6.36 ± 1.94 days vs 5.94 ± 1.36 days, P = .125), total complication rate (18.6 % vs 14.1 %, P = .382), stone clearance rate (93.2 % vs 96.3 %, P = .303), stone recurrence rate (3.4 % vs 1.7 %, P = .395), and conversion rate (6.8 % vs 7.0 %, P = .941) between the 2 groups. No deaths occurred in either groups. A history of gastrectomy may not affect the feasibility and safety of LTCBDE, because its perioperative results are comparable to those of patients with a history of No-gastrectomy.

Background and study aims Biliary sphincterotomy is a crucial step in endoscopic retrograde cholangiopancreatography (ERCP), a procedure known to carry a 5% to 10% risk of complications. The relationship between Pure cut, Endocut, post-ERCP pancreatitis (PEP) and bleeding is unclear. This systematic review and meta-analysis compared these two current types and their relationships with adverse events. Patients and methods This systematic review involved searching articles in multiple databases until August 2023 comparing pure cut versus Endocut in biliary sphincterotomy. The meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Results A total of 987 patients from four randomized controlled trials were included. Overall pancreatitis: A higher risk of pancreatitis was found in the Endocut group than in the Pure cut group ( P =0.001, RD=0.04 [range, 0.01 to 0.06]; I 2 =29%). Overall immediate bleeding: Statistical significance was found to favor Endocut, ( P =0.05; RD=-0.15 [range, -0.29 to -0.00]; I 2 =93%). No statistical significance between current modes was found in immediate bleeding without endoscopic intervention ( P =0.10; RD=-0.13 [range, -0.29 to 0.02]; I 2 =88%), immediate bleeding with endoscopic intervention ( P =0.06; RD=-0.07 [range, -0.14 to 0.00]; I 2 =76%), delayed bleeding (P=0.40; RD=0.01 [range, -0.02 to 0.05]; I 2 =72%), zipper cut ( P =0.58; RD=-0.03 [range, -0.16 to 0.09]; I 2 =97%), perforation ( P =1.00; RD=0.00 [range, -0.01 to 0.01]; I 2 =0%) and cholangitis ( P =0.77; RD=0.00 [range, -0.01 to 0.02]; I 2 =29%). Conclusions The available data in the literature show that Endocut carries an increased risk for PEP and does not prevent delayed or clinically significant bleeding, although it prevents intraprocedural bleeding. Based on such findings, Pure cut should be the preferred electric current mode for biliary sphincterotomy.