The 90% effective dose (ED90) of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP.

BACKGROUND: Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, this study aims to determine the 90% effective dose (ED90) of remimazolam to inhibit responses to insertion of a duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP). METHODS: A dose-response study was carried out undergoing ERCP who received remimazolam-alfentanil anesthesia using 10 µg/kg of alfentanil between September 2021 and November 2021. The initial dose of remimazolam was 0.2 mg/kg. The dose was then decided based on the responses of earlier patients by exploiting the sequential ascend and descend according to a 9: 1 biased coin design. Upon failure, the dose of remimazolam was increased by 0.025 mg/kg in the next patient. When the insertion was successful, the succeeding patient was randomized to an identical dose or a dose that was lower by 0.025 mg/kg.The ED90 of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP was calculated. Adverse events and complications of remimazolam were recorded. RESULTS: A total of 55 elderly patients (age > 65) were included in the study. 45 successfully anesthetized patients, and 10 unsuccessfully. The ED90 of remimazolam was 0.300 mg/kg (95% CI = 0.287-0.320). ED95 was 0.315 (95% CI = 0.312-0.323) and ED99 was 0.323 (95% CI = 0.323-0.325). Among the patients, 9 patients developed hypotension, 2 patients developed bradycardia and 1 patient developed tachycardia, and hypoxia occurred in 2 patients. CONCLUSIONS: A loading dose of 0.300 mg / kg of remimazolam for elderly patients undergoing ERCP can safely, effectively, and quickly induce patients to fall asleep and inhibit responses to the insertion of a duodenoscope. TRIAL REGISTRATION: The study protocol was registered at the website ClinicalTrials.gov on 22/09/2021(NCT05053763).

Safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation of elderly patients undergoing ERCP.

BACKGROUND: Proper sedation of patients, particularly elderly individuals, who are more susceptible to sedation-related complications, is of significant importance in endoscopic retrograde cholangiopancreatography (ERCP). This study aims to assess the safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation in elderly patients undergoing ERCP, compared to a group of middle-aged patients. METHODS: The medical records of 610 patients with common bile duct stones who underwent elective ERCP under deep sedation with a three-drug regimen, including midazolam, alfentanil, and propofol at Shandong Provincial Third Hospital from January 2023 to September 2023 were retrospectively reviewed in this study. Patients were categorized into three groups: middle-aged (50-64 years, n = 202), elderly (65-79 years, n = 216), and very elderly (≥ 80 years, n = 192). Intraoperative vital signs and complications were compared among these groups. RESULTS: The three groups showed no significant difference in terms of intraoperative variation of systolic blood pressure (P = 0.291), diastolic blood pressure (P = 0.737), heart rate (P = 0.107), peripheral oxygen saturation (P = 0.188), bispectral index (P = 0.158), and the occurrence of sedation-related adverse events including hypotension (P = 0.170) and hypoxemia (P = 0.423). CONCLUSION: The results suggest that a low-dose three-drug regimen consisting of midazolam, alfentanil, and propofol seems safe and effective for deep sedation of elderly and very elderly patients undergoing ERCP procedures. However, further studies are required to verify these findings and clarify the benefits and risks of this method.

Risk Factors and Risk Assessment for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

OBJECTIVE: To analyse the pertinent risk factors associated with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) and develop a predictive scoring system for assessing the risk of PEP in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) procedures. STUDY DESIGN: Descriptive study. Place and Duration of the Study: Department of Gastroenterology, Nantong First People's Hospital, Jiangsu, China, from January 2022 to January 2023. METHODOLOGY: Clinical data of 375 patients who underwent successful ERCP treatment were collected and organised. Relevant risk factors for PEP were analysed, and a scoring system was established to predict the risk of PEP. RESULTS: Among the 375 patients who underwent ERCP, the incidence of PEP was 9.07% (34/375). Univariate analysis revealed that female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, sphincter of Oddi dysfunction (SOD), and biliary stenting were risk factors for PEP. Multivariate analysis showed that female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, and SOD were independent risk factors for PEP. A scoring system was developed, and the receiver operating characteristic (ROC) curve analysis determined a cut-off value of 1.5 points. Patients with a score less than 1.5 points had a low probability of developing PEP, while those with a score greater than 1.5 points had a significantly higher probability of PEP. CONCLUSION: Female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, and SOD were independent risk factors for PEP. Additionally, a reliable scoring system was established to predict the risk of PEP. Clinicians can use this scoring system to assess the risk of PEP in patients and implement preventive measures to reduce the incidence of PEP. KEY WORDS: Endoscopic retrograde cholangiopancreatography, Post-ERCP pancreatitis, Risk factors, Risk assessment, Preventive measure.

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

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) has found extensive use in pediatric patients; however, challenges persist in the application of therapeutic ERCP in infants. CASE PRESENTATION: This 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. CONCLUSIONS: In 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.

Morphology of the papilla can predict procedural safety and efficacy of ERCP-a systematic review and meta-analysis.

Endoscopic Retrograde Cholangiopancreatography (ERCP) is the primary therapeutic procedure for pancreaticobiliary disorders, and studies highlighted the impact of papilla anatomy on its efficacy and safety. Our objective was to quantify the influence of papilla morphology on ERCP outcomes. We systematically searched three medical databases in September 2022, focusing on studies detailing the cannulation process or the rate of adverse events in the context of papilla morphology. The Haraldsson classification served as the primary system for papilla morphology, and a pooled event rate with a 95% confidence interval was calculated as the effect size measure. Out of 17 eligible studies, 14 were included in the quantitative synthesis. In studies using the Haraldsson classification, the rate of difficult cannulation was the lowest in type I papilla (26%), while the highest one was observed in the case of type IV papilla (41%). For post-ERCP pancreatitis, the event rate was the highest in type II papilla (11%) and the lowest in type I and III papilla (6-6%). No significant difference was observed in the cannulation failure and post-ERCP bleeding event rates between the papilla types. In conclusion, certain papilla morphologies are associated with a higher rate of difficult cannulation and post-ERCP pancreatitis.

Italian Survey on Endoscopic Biliary Drainage Approach in Patients with Surgically Altered Anatomy.

Background and Objectives: Biliary drainage (BD) in patients with surgically altered anatomy (SAA) could be obtained endoscopically with different techniques or with a percutaneous approach. Every endoscopic technique could be challenging and not clearly superior over another. The aim of this survey is to explore which is the standard BD approach in patients with SAA. Materials and Methods: A 34-question online survey was sent to different Italian tertiary and non-tertiary endoscopic centers performing interventional biliopancreatic endoscopy. The core of the survey was focused on the first-line and alternative BD approaches to SAA patients with benign or malignant obstruction. Results: Out of 70 centers, 39 answered the survey (response rate: 56%). Only 48.7% of them declared themselves to be reference centers for endoscopic BD in SAA. The total number of procedures performed per year is usually low, especially in non-tertiary centers; however, they have a low tendency to refer to more experienced centers. In the case of Billroth-II reconstruction, the majority of centers declared that they use a duodenoscope or forward-viewing scope in both benign and malignant diseases as a first approach. However, in the case of failure, the BD approach becomes extremely heterogeneous among centers without any technique prevailing over the others. Interestingly, in the case of Roux-en-Y, a significant proportion of centers declared that they choose the percutaneous approach in both benign (35.1%) and malignant obstruction (32.4%) as a first option. In the case of a previous failed attempt at BD in Roux-en-Y, the subsequent most used approach is the EUS-guided intervention in both benign and malignant indications. Conclusions: This survey shows that the endoscopic BD approach is extremely heterogeneous, especially in patients with Roux-en-Y reconstruction or after ERCP failure in Billroth-II reconstruction. Percutaneous BD is still taken into account by a significant proportion of centers in the case of Roux-en-Y anatomy. The total number of endoscopic BD procedures performed in non-tertiary centers is usually low, but this result does not correspond to an adequate rate of referral to more experienced centers.

Balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography for hepatolithiasis in patients with hepaticojejunostomy.

BACKGROUND AND AIM: Balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) is an emerging procedure for pancreatobiliary diseases in patients with surgically altered anatomy. However, data on BE-ERCP for hepatolithiasis after hepaticojejunostomy (HJS) are still limited. METHODS: Stone removal success, adverse events and recurrence were retrospectively studied in consecutive patients who underwent BE-ERCP for hepatolithiasis after HJS between January 2011 and October 2022. Subgroup analysis was performed to compare clinical outcomes between patients who had undergone HJS over 10 years before (past HJS group) and within 10 years (recent HJS group). RESULTS: A total of 131 patients were included; 39% had undergone HJS for malignancy and 32% for congenital biliary dilation. Scope insertion and complete stone removal were successful in 89% and 73%, respectively. Early adverse events were observed in 9.9%. Four patients (3.1%) developed gastrointestinal perforation but could be managed conservatively. Hepatolithiasis recurrence rate was 17%, 20% and 31% in 1-year, 3-year, and 5-year after complete stone removal. The past HJS group was the only risk factor for failed stone removal (odds ratio 10.4, 95% confidence interval 2.99-36.5) in the multivariable analysis. Failed scope insertion (20%) and failed guidewire or device insertion to the bile duct (22%) were two major reasons for failed stone removal in the past HJS group. CONCLUSIONS: BE-ERCP for hepatolithiasis was effective and safe in cases with HJS but the complete stone removal rate was low in the past HJS group. Recurrent hepatolithiasis was common and careful follow up study is needed even after complete stone removal.

Comparison of laparoscopic common bile duct exploration plus cholecystectomy and endoscopic retrograde cholangiopancreatography followed by laparoscopic cholecystectomy for elderly patients with common bile duct stones and gallbladder stones.

BACKGROUND: Common bile duct (CBD) stones commonly occur in cholecystectomy cases. The management options include laparoscopic CBD exploration (LCBDE) or endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC). Although ERCP is fully developed, it has complications, and LCBDE is a proven alternative. This study aimed to evaluate the safety and efficacy of these treatments in elderly individuals aged ≥70 years. METHODS: A retrospective study between January 2015 and July 2022 included 160 elderly patients (aged ≥70 years) diagnosed with cholelithiasis and choledocholithiasis. The patients were divided into 1-stage (LCBDE [n = 80]) or 2-stage (ERCP followed by LC [n = 80]) treatment groups. Data collected encompassed comorbidities, symptoms, bile duct clearance, postoperative complications, and long-term outcomes for systematic analysis. RESULTS: This study analyzed 160 patients treated for CBD stones, comparing 1-stage and 2-stage groups. The 1-stage group had more female patients than the 2-stage group (57.5% vs 37.5%, respectively). The 1-stage group had a mean age of 80.55 ± 7.00 years, which was higher than the mean age in the 2-stage group. American Society of Anesthesiologists classification, Charlson Comorbidity Index, and laboratory findings were similar. Pancreatitis and cholangitis occurred after ERCP in the 2-stage group. Stone clearance rates (92.35% [1-stage group] vs 95.00% [2-stage group]) and biliary leakage incidence (7.5% [1-stage group] vs 3.0% [2-stage group]) were similar, as were postoperative complications and long-term recurrence rates (13.0% [1-stage group] vs 12.5% [2-stage group]). CONCLUSION: Our research indicates that both the combination of LCBDE and LC and the sequence of ERCP followed by LC are equally efficient and secure when treating CBD stones in elderly patients. Consequently, the 1-stage procedure may be considered the preferred treatment approach for this demographic.

A nomogram for prediction of ERCP success in patients with bile duct leaks: a multicenter study.

BACKGROUND: Bile duct leaks (BDLs) are serious complications that occurs after hepatobiliary surgery and trauma, leading to rapid clinical deterioration. Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line treatment for BDLs, but it is not clear which patients will respond to this therapy and which patients will require additional surgical intervention. The aim of our study was to explore the predictors of successful ERCP for BDLs. METHODS: A retrospective analysis was conducted using data from six centers' databases. All consecutive patients who were clinically confirmed as BDLs were included in the study. Collected data were demographics, disease severity, and ERCP procedure characteristics. Univariate and multivariate analysis were used to select independent predictive factors that affect the outcome of ERCP for BDLs, and a nomogram was established. Calibration and ROC curves were used to evaluate the models. RESULTS: Four hundred and forty-eight consecutive patients were clinically confirmed as BDLs and 347 were excluded. In the 101 patients included patients, clinical success was achieved in 78 patients (77.2%). In logistic multivariable regression, two independent factors were negatively associated with the success of ERCP: SIRS (OR, 0.183; 95% CI 0.039-0.864; P = 0.032) and high-grade leak (OR 0.073; 95% CI 0.010-0.539; P = 0.010). Two independent factors were positively associated with the success of ERCP: leak-bridging drainage (OR 4.792; 95% CI 1.08-21.21; P = 0.039) and cystic duct leak (OR 6.193; 95% CI 1.03-37.17; P = 0.046). The prediction model with these four factors was evaluated using a receiver-operating characteristic (ROC) curve, which demonstrated an area under the curve of 0.9351. The calibration curve showed that the model had good predictive accuracy. CONCLUSION: Leak-bridging drainage and cystic duct leak are positive predictors for the success of ERCP, while SIRS and high-grade leak are negative predictors. This prediction model with nomogram has good predictive ability and practical clinical value, and may be helpful in clinical decision-making and prognostication.

ERCP for common bile duct stones in the elderly: refining the procedure to improve outcomes.

Removal of common bile duct stones in patients with a previous cholecystectomy was one of the first indications for ERCP with biliary sphincterotomy. Thanks to a minimally invasive procedure, patients were prevented from having a new operation. Subsequently, as the technique proved to be successful, ERCP was extended to all patients with choledocholithiasis, regardless of whether or not they had gallbladder. Also contributing was the fact that, at least in the beginnings, surgical interventions on the bile duct with laparoscopic cholecystectomy were more difficult. Nowadays, many surgeons prefer to perform cholecystectomy with a bile duct clean of stones. In this issue of the Spanish Journal of Gastroenterology, Gardenyes et al. present a study on ERCP for common bile duct stones in elderly patients. The novelty of this study is not only to analyze the ERCP procedure, which we already knew has similar success and complication rates to younger patients, but also to focus on the long-term outcome, considering the frailty that frequently accompanies aging. The study concludes that older patients may benefit from enhanced care protocols to reduce medical adverse events and improve outcomes. For us gastroenterologists and endoscopists, another conclusion that can be drawn from this study is that we should not be satisfied that ERCP in older patients has the same success and complication rates as in younger patients, but rather we should strive to ensure that the results are even better.

Cost-effectiveness Analysis of Single-Use Duodenoscope Applied to Endoscopic Retrograde Cholangiopancreatography.

OBJECTIVES: Secondary infections due to transmission via the duodenoscope have been reported in up to 3% of endoscopic retrograde cholangiopancreatographies. The use of single-use duodenoscopes has been suggested. We investigate the cost-effectiveness of these duodenoscopes use in cholangiopancreatography. MATERIALS AND METHODS: A cost-effectiveness analysis was implemented to compare the performance of cholangiopancreatographies with reusable duodenoscopes versus single-use duodenoscopes. Effectiveness was analyzed by calculating quality-adjusted life years (QALY) from the perspective of the National Health System. Possibility of crossover from single-use to reusable duodenoscopes was considered. A willingness-to-pay of €25,000/QALY was set, the incremental cost-effectiveness ratio (ICER) was calculated, and deterministic and probabilistic sensitivity analyses were performed. RESULTS: Considering cholangiopancreatographies with single-use and reusable duodenoscopes at a cost of €2900 and €1333, respectively, and a 10% rate of single-use duodenoscopes, ICER was greater than €3,000,000/QALY. A lower single-use duodenoscope cost of €1211 resulted in an ICER of €23,583/QALY. When the unit cost of the single-use duodenoscope was €1211, a crossover rate of more than 9.5% made the use of the single-use duodenoscope inefficient. CONCLUSIONS: Single-use duodenoscopes are cost-effective in a proportion of cholangiopancreatographies if its cost is reduced. Increased crossover rate makes single-use duodenoscope use not cost-effective.

Percutaneous placement of a retrievable fully covered metal stent with anchoring flaps for the treatment of biliary anastomotic stricture following LDLT.

To investigate the outcomes following percutaneous placement of a retrievable fully covered self-expanding metal stent (fcSEMS) with anchoring flaps at proximal and distal ends for the treatment of biliary anastomotic strictures following living-donor liver transplantation (LDLT). We retrospectively reviewed the medical records of nine patients who underwent this procedure at our centre between April 2020 and March 2021. Percutaneous stent placement was technically successful in 100% patients, and all stents were successfully retrieved. No proximal or distal stent migration or occlusion was observed during the mean (±SD) stent indwelling period of 191(± 77) days. Clinical success was 89%. There was one major bleeding complication related to the biliary approach and one minor stent-related complication of calculus/sludge. During the mean (±SD) follow-up period of 595 ± 207 days after stent retrieval, only one patient developed recurrent clinical biliary stricture and symptoms. Percutaneous placement of a retrievable fcSEMS with anchoring flaps is safe and feasible for the treatment of biliary anastomotic strictures following LDLT.