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.

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.

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.

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.

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.

Pilot study on cultural and metagenomic analysis of bile and biliary stentslead to unveiling the key players in stent occlusion.

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with biliary stenting is a minimally invasive medical procedure employed to address both malignant and benign obstructions within the biliary tract. Benign biliary strictures (BBSs), typically arising from surgical interventions such as liver transplants and cholecystectomy, as well as chronic inflammatory conditions, present a common clinical challenge. The current gold standard for treating BBSs involves the periodic insertion of plastic stents at intervals of 3-4 months, spanning a course of approximately one year. Unfortunately, stent occlusion emerges as a prevalent issue within this treatment paradigm, leading to the recurrence of symptoms and necessitating repeated ERCPs. In response to this clinical concern, we initiated a pilot study, delving into the microbial composition present in bile and on the inner surfaces of plastic stents. This investigation encompassed 22 patients afflicted by BBSs who had previously undergone ERCP with plastic stent placement. Our preliminary findings offered promising insights into the microbial culprits behind stent occlusion, with Enterobacter and Lactobacillus spp. standing out as prominent bacterial species known for their biofilm-forming tendencies on stent surfaces. These revelations hold promise for potential interventions, including targeted antimicrobial therapies aimed at curtailing bacterial growth on stents and the development of advanced stent materials boasting anti-biofilm properties.

Evaluation of the effectiveness and safety of single-operator cholangiopancreatoscopy with the SpyGlass™ system / Evaluación de la eficacia y seguridad de la colangiopancreatoscopia de un solo operador con el sistema SpyGlass®

Background and study aims The single-operator cholangiopancreatoscopy (SOCP) with the SpyGlass™ system is a endoscopy technique whose use has grown exponentially in recent years. The aims of this study were to evaluate the efficacy and safety of SOCP with SpyGlass™ and determine the factors related to the onset of adverse events (AEs). Patients and methods Retrospective study at a single tertiary institution with inclusion of all consecutive patients undergoing SOCP with SpyGlass™ from February-2009 to December-2021. No exclusion criteria were considered. A descriptive statistical analysis was performed. The factors associated with the existence of AE were analyzed using Chi-square and Student's t-test. Results A total of 95 cases were included. The most common indications were biliary strictures (BS) evaluation (66.3%) or treatment of difficult common bile duct stones (27.4%). Technical and clinical success was attained in 98.9%. Single-session stone clearance was obtained in 84%. The AE rate was 7.4%. To detect malignancy in BS, optical diagnosis presents a sensitivity and specificity of 100% and 91.2%, respectively; while histology results were 36.4% and 100% respectively. A previous endoscopic sphincterotomy was associated with a lower rate of AEs (2.4% vs 41.7%; p < 0.001). Conclusions SOCP with SpyGlass™ is a safe and effective technique to diagnose and treat pancreatobiliary pathology. The presence of sphincterotomy performed prior to the procedure could improve the technique's safety (AU)

Antecedentes y objetivos del estudio La colangiopancreatoscopia de un solo operador (SOCP) con el sistema SpyGlass® es una técnica endoscópica cuyo uso ha crecido exponencialmente durante los últimos años. Los objetivos de este estudio fueron evaluar la eficacia y seguridad de la SOPC con SpyGlass® y determinar los factores relacionados con la aparición de eventos adversos (EA). Pacientes y métodos Estudio retrospectivo realizado en un único centro terciario, con inclusión consecutiva de todos los pacientes sometidos a SOCP con SpyGlass® desde febrero de 2009 hasta diciembre de 2021. No hubo criterios de exclusión. Se realizó un análisis estadístico descriptivo. Los factores asociados a la aparición de EA se analizaron mediante χ2 y la prueba t de Student. Resultados Se incluyeron un total de 95 casos. Las indicaciones más frecuentes fueron la evaluación de estenosis biliares (EB) (66,3%) o el tratamiento de coledocolitiasis difícil (27,4%). El éxito técnico y clínico se logró en 98,9%. La extracción de todas las litiasis en una sola sesión se obtuvo en 84%. La tasa de EA fue de 7,4%. Para la detección de malignidad en EB, el diagnóstico óptico presenta una sensibilidad y especificidad de 100% y 91,2%, respectivamente; mientras que los resultados de la histología fueron 36,4 y 100%, respectivamente. La esfinterotomía endoscópica previa se asocia con una menor tasa de EA (2,4 vs. 41,7%; p < 0,001). Conclusiones La SOCP con SpyGlass® es una técnica segura y eficaz para diagnosticar y tratar la patología biliopancreática. La presencia de esfinterotomía previa al procedimiento podría mejorar la seguridad de la técnica (AU)

A Novel Technique for the Management of Persistent Biliary Fistulas Developing After Liver Hydatid Cyst Surgeries: Drain Clamping Technique.

BACKGROUND: External biliary fistula, where the residual cyst is associated with the biliary tree, is one of the most common complications after liver hydatid cyst surgery. Surgical procedures become a consideration for patients in whom the biliary fistula persists despite all endoscopic procedures. However, reoperation for biliary fistula after hydatid cyst surgery leads to additional complications and increases morbidity and mortality. AIM: This study aims to treat persistent biliary fistulas that develop after liver hydatid cyst surgery using a simple noninvasive technique. MATERIALS AND METHODS: External drainage surgery was performed on 295 patients with liver hydatid cysts. Endoscopic treatment methods were used in patients who developed biliary fistula after surgery. Despite all endoscopic treatment methods, 14 patients developed persistent biliary fistulas. These patients were subsequently treated using the drain clamping technique. FINDINGS: All persistent fistulas occluded in 11.86 days (with a range of 8-20 days). No complications were observed in the one-year follow-up visits. CONCLUSION: Drain clamping, a novel approach to the treatment of persistent biliary fistulas developed despite all available endoscopic methods, can be safely used. This technique resulted in a complete recovery in patients without the need for surgical procedures.

Curative surgical treatment of common bile duct stones: Retrospective cohort study.

BACKGROUND: In the event of symptomatic common bile duct (CBD) stones with dilated CBD, one possible curative treatment option is stone extraction through choledocotomy associated with cholecystectomy. Endoscopic treatment is only reserved for residual stones at 6 weeks. The aim of this study was to evaluate the results from laparoscopic curative surgical treatment of CBD stones with dilated CBD. METHODS: This is a retrospective single-centered cohort study. All consecutive patients admitted for laparoscopic cholecystectomy with evidence of CBD stones with dilated CBD from January 2010 to December 2020 at our center were included. Success was defined by CBD clearance at 6 weeks. Need for additional procedures, such as endoscopic sphincterotomy, immediate, and end-of-procedure morbi-mortality as well as factors associated with procedure failure, were also studied. RESULTS: A total of 246 patients who received curative treatment were included in the study. The success rate for the curative treatment was 93.1% (229 patients). Immediate postoperative morbidity was 24.4% with a 5.3% reintervention rate. Immediate and 6-week postoperative mortality rates were zero and 0.4%, respectively. The mean length of stay was 11.3 days. Factors associated with procedure failure appeared to be the occurrence of an early postoperative complication and the need for readmission during the period between surgery and drain removal. CONCLUSION: This study indicates that laparoscopic curative surgical treatment for symptomatic CBD stones may be performed with acceptable results without routine need for additional procedures.

Accessibility to ERCP-performing hospitals among patients with pancreatic cancer living in SEER regions.

BACKGROUND AND AIMS: The two most common interventions used to treat painless jaundice from pancreatic cancer are endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic biliary drainage (PTBD). Our study aimed to characterize the geographic distribution of ERCP-performing hospitals among patients with pancreatic cancer in the United States and the association between geographic accessibility to ERCP-performing hospitals and biliary interventions patients receive. METHODS: This is a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database for pancreatic cancer from 2005 to 2013. Multilevel models were used to examine the association between accessibility to ERCP hospitals within a 30- and 45-min drive from the patient's residential ZIP Code and the receipt of ERCP treatment. A two-step floating catchment area model was used to calculate the measure of accessibility based on the distribution across SEER regions. RESULTS: 7464 and 782 patients underwent ERCP and PTBD, respectively, over the study period. There were 808 hospitals in which 8246 patients diagnosed with pancreatic cancer in SEER regions from 2005 to 2013 received a procedure. Patients with high accessibility within both 30- and 45-min drive to an ERCP-performing hospital were more likely to receive an ERCP (30-min adjusted odds ratio [aOR]: 1.53, 95% confidence interval [CI]: 1.17-2.01; 45-min aOR: 1.31, 95% CI: 1.01-1.70). Furthermore, in the adjusted model, Black patients (vs. White) and patients with stage IV disease were less likely to receive ERCP than PTBD. CONCLUSIONS: Patients with pancreatic cancer and high accessibility to an ERCP-performing hospital were more likely to receive ERCP. Disparities in the receipt of ERCP persisted for Black patients regardless of their access to ERCP-performing hospitals.

Impact of duodenal papilla anatomy on needle knife papillotomy safety and efficacy in patients with difficult biliary canulation.

BACKGROUND AND AIMS: Needle-knife papillotomy (NKP) is widely performed when biliary cannulation is difficult during endoscopic retrograde cholangiopancreatography (ERCP). However, its safety and efficacy in different types of duodenal papilla are not clear. PATIENTS AND METHODS: This retrospective study analyzed 217 patients with difficult biliary cannulation who underwent NKP during ERCP procedures from June 2013 to May 2022 in our institution. Patients were classified according to Haraldsson classification type of duodenal papilla: type 1, regular; type 2, small; type 3, protruding or pendulous; and type 4, creased or ridged. Outcome measures were successful biliary cannulation and incidence of adverse events. RESULTS: Haraldsson classification was type 1 in 115 patients, type 2 in 29, type 3 in 52, and type 4 in 21. Biliary cannulation was successful in 166 patients (76.5%) Success rates according to Haraldsson type were as follows: type 1, 74.8%; type 2, 82.8%; type 3, 80.8%; and type 4, 66.7%. The rates did not significantly differ among the types (p = 0.48). Overall incidence of adverse events was 9.22%. Incidence of adverse events did not significantly differ among the types (p = 0.69). CONCLUSIONS: NKP was useful to achieve successful cannulation in patients with difficult biliary cannulation. The rate of successful cannulation and incidence of adverse events were similar among the different types of duodenal papilla.

Will Endoscopic-Ultrasound-Guided Choledocoduodenostomy with Electrocautery-Enhanced Lumen-Apposing Metal Stent Placement Replace Endoscopic Retrograde Cholangiopancreatography When Treating Distal Malignant Biliary Obstructions?

Malignant distal biliary obstructions are becoming increasingly common, especially in patients with cancers of the pancreatic head, despite progress in medical oncology research. ERCP is the current gold standard for management of such strictures, but the emergence of EC-LAMS has rendered EUS-CDS both safe and efficient. It is a "game changer"; originally intended for ERCP failure, two randomised clinical trials recently proposed EUS-CDS as a first-intent procedure in palliative settings. For resectable diseases, the absence of iatrogenic pancreatitis associated with a lower rate of postsurgical adverse events (compared with ERCP) leads us to believe that EUS-CDS might be used in first-intent as a pre-operative endoscopic biliary drainage.

Endoscopic Management of Difficult Biliary Stones: An Evergreen Issue.

Choledocholithiasis is one of the most common indications for endoscopic retrograde cholangiopancreatography (ERCP) in daily practice. Although the majority of stones are small and can be easily removed in a single endoscopy session, approximately 10-15% of patients have complex biliary stones, requiring additional procedures for an optimum clinical outcome. A plethora of endoscopic methods is available for the removal of difficult biliary stones, including papillary large balloon dilation, mechanical lithotripsy, and electrohydraulic and laser lithotripsy. In-depth knowledge of these techniques and the emerging literature on them is required to yield the most optimal therapeutic effects. This narrative review aims to describe the definition of difficult bile duct stones based on certain characteristics and streamline their endoscopic retrieval using various modalities to achieve higher clearance rates.