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.

Uncovering the spread of drug-resistant bacteria through next-generation sequencing based surveillance: transmission of extended-spectrum ß-lactamase-producing Enterobacterales by a contaminated duodenoscope.

Contamination of duodenoscopes is a significant concern due to the transmission of multidrug-resistant organisms (MDROs) among patients who undergo endoscopic retrograde cholangiopancreatography (ERCP), resulting in outbreaks worldwide. In July 2020, it was determined that three different patients, all had undergone ERCP with the same duodenoscope, were infected. Two patients were infected with blaCTX-M-15 encoding Citrobacter freundii, one experiencing a bloodstream infection and the other a urinary tract infection, while another patient had a bloodstream infection caused by blaSHV-12 encoding Klebsiella pneumoniae. Molecular characterization of isolates was available as every ESBL-producing isolate undergoes Next-Generation Sequencing (NGS) for comprehensive genomic analysis in our center. After withdrawing the suspected duodenoscope, we initiated comprehensive epidemiological research, encompassing case investigations, along with a thorough duodenoscope investigation. Screening of patients who had undergone ERCP with the implicated duodenoscope, as well as a selection of hospitalized patients who had ERCP with a different duodenoscope during the outbreak period, led to the discovery of three additional cases of colonization in addition to the three infections initially detected. No microorganisms were detected in eight routine culture samples retrieved from the suspected duodenoscope. Only after destructive dismantling of the duodenoscope, the forceps elevator was found to be positive for blaSHV-12 encoding K. pneumoniae which was identical to the isolates detected in three patients. This study highlights the importance of using NGS to monitor the transmission of MDROs and demonstrates that standard cultures may fail to detect contaminated medical equipment such as duodenoscopes.

Unveiling 8 years of duodenoscope contamination: insights from a retrospective analysis in a large tertiary care hospital.

OBJECTIVE: Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated with gastrointestinal microorganisms. This study aimed to provide an overview of duodenoscope contamination over time, identify risk factors and study the effects of implemented interventions. DESIGN: Duodenoscope culture sets between March 2015 and June 2022 at a Dutch tertiary care centre were analysed. Contamination was defined as (1) the presence of microorganisms of oral or gastrointestinal origin (MGO) or (2) any other microorganism with ≥20 colony-forming units/20 mL (AM20). A logistic mixed effects model was used to identify risk factors and assess the effect of interventions, such as using duodenoscopes with disposable caps, replacing automated endoscope reprocessors (AER) and conducting audits in the endoscopy department. RESULTS: A total of 404 culture sets were analysed. The yearly contamination rate with MGO showed great variation, ranging from 14.3% to 47.5%. Contamination with AM20 increased up to 94.7% by 2022. For both MGO and AM20, the biopsy and suction channels were the most frequently contaminated duodenoscope components. The studied interventions, including audits, AER replacement and implementation of duodenoscopes with disposable caps, did not show a clear association with contamination rates. CONCLUSION: Duodenoscope contamination remains a significant problem, with high contamination rates despite several interventions. Reprocessing the biopsy and suction channels is especially challenging. Changes in the design of reusable duodenoscopes, such as enabling sterilisation or easily replaceable channels, are necessary to facilitate effective duodenoscope reprocessing and to eliminate the risk of duodenoscope-associated infections.

A Novel Dry Simulator Model for Learning Comprehensive Endoscopic Retrograde Cholangiopancreatography/Endoscopic Sphincterotomy Procedures while Minimizing Adverse Bleeding Events (with Video).

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. METHODS: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. RESULTS: The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. CONCLUSIONS: This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.

BACKGROUND: Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP. RESULTS: Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08). CONCLUSIONS: The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.

Single-use accessories and endoscopes in the era of sustainability and climate change-A balancing act.

Gastrointestinal (GI) endoscopy is among the highest waste generator in healthcare facilities. The major reasons include production of large-volume non-renewable waste, use of single-use devices, and reprocessing or decontamination processes. Single-use endoscopic accessories have gradually replaced reusable devices over last two decades contributing to the rising impact of GI endoscopy on ecosystem. Several reports of infection outbreaks with reusable duodenoscopes raised concerns regarding the efficacy and adherence to standard disinfection protocols. Even the enhanced reprocessing techniques like double high-level disinfection have not been found to be the perfect ways for decontamination of duodenoscopes and therefore, paved the way for the development of single-use duodenoscopes. However, the use of single-use endoscopes is likely to amplify the net waste generated and carbon footprint of any endoscopy unit. Moreover, single-use devices challenge one of the major pillars of sustainability, that is, "reuse." In the era of climate change, a balanced approach is required taking into consideration patient safety as well as financial and environmental implications. The possible solutions to provide optimum care while addressing the impact on climate include selective use of disposable duodenoscopes and careful selection of accessories during a case. Other options include use of disposable endcaps and development of effective high-level disinfection techniques. The collaboration between the healthcare professionals and the manufacturers is paramount for the development of environmental friendly devices with low carbon footprint.

Effect of a novel endoscope cleaning brush on duodenoscope contamination.

BACKGROUND: Current duodenoscope reprocessing protocols are insufficient to prevent contamination and require adaptations to prevent endoscopy-associated infections (EAIs). This study aimed to investigate the effect of a new endoscope cleaning brush on the contamination rate of ready-to-use duodenoscopes. METHODS: This retrospective before-and-after intervention study collected duodenoscope surveillance culture results from March 2018 to June 2022. Contamination was defined as ≥1 colony-forming unit of a microorganism of gut or oral origin (MGO). In December 2020, an endoscope cleaning brush with a sweeper design was introduced as an intervention in the manual cleaning of duodenoscopes. A logistic mixed-effects model was used to study the effects of this intervention. RESULTS: Data were collected from 176 culture sets before the new brush's introduction and 81 culture sets afterwards. Pre-introduction, culture sets positive with an MGO comprised 45.5% (95%CI 38.3%-52.8%; 80/176), decreasing to 17.3% (95%CI 10.6%-26.9%; 14/81) after implementation of the new brush. Compared with the former brush, duodenoscopes cleaned with the new brush had lower odds of contamination with MGOs (adjusted odds ratio 0.25, 95%CI 0.11-0.58; P=0.001) CONCLUSIONS: Use of the new brush in manual cleaning reduced contamination with MGOs and is expected to prevent EAIs. These findings should be confirmed in future prospective randomized studies.

Beyond duodenoscope-transmitted infections: Analysis of surface bioburden and UV-C mitigation within a tertiary care endoscopy unit.

BACKGROUND: An inpatient endoscopy unit is a care hub for patients from throughout the hospital and can be the site of health care-associated infections (HAIs). Shared surfaces and other nonmedical devices (keyboards) have been increasingly recognized as sites of pathogen transmission. Beyond standard cleaning of high-touch target areas, we queried whether the addition of automated devices delivering low-intensity doses of ultraviolet (UV)-C radiation could further reduce bioburden in an academic endoscopy unit. METHODS: Bioburden on previously identified high-touch/communal surfaces was measured before and after the installation of automated, low-intensity UV-light emitting devices (UV Angel) that passively monitor and disinfect targeted surfaces with Ultraviolet-C light (UV-C) light. RESULTS: High-touch sites (keyboards) had a baseline bacterial contamination of >80%, whereas individual procedure rooms and common areas had a >57% contamination rate. Following the implementation of automated UV-C light decontamination, bioburden was reduced on average by >91% at high-touch surfaces and within procedure rooms. DISCUSSION/CONCLUSIONS: Nonsterile hubs of patient care could serve as sites of "silent" HAI transmission. We have identified high-touch surfaces within an endoscopy unit that have a high bioburden of bacterial contamination and demonstrated that the installation of passive, automated UV-C light disinfection devices can reduce bioburden significantly, possibly mitigating HAI transmission between patients.

A Road Less Traveled: Endoscopic Retrograde Cholangiopancreatography in a Patient with Long-standing Achalasia and Sigmoid Esophagus.

Endoscopic retrograde cholangiopancreatography in a patient with achalasia and sigmoid esophagus poses a unique technical challenge, as one must safely guide the side viewing duodenoscope across a severely distorted distal esophagus and non-relaxing lower esophageal sphincter. In such patients, the use of an overtube is a simple solution that allows the safe passage of a duodenoscope and the removal of common bile duct stones.

Duodenoscope insertion difficulty due to perigastric adhesions overcome using an overtube.

Kawakami and colleagues report a case of duodenoscope insertion difficulty through the pyloric ring due to perigastric adhesions which was successfully overcome using an overtube. The overtube can be attached to both standard and therapeutic duodenoscopes, allowing successful biliary or pancreatic intervention in patients in whom duodenoscopic insertion is challenging.

Efficacy of cap-assisted endoscopy for the visualization of the major duodenal papilla: a systematic review and meta-analysis.

BACKGROUND AND AIMS: The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative. METHODS: A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP. RESULTS: Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I2 = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I2 = 45.303%). CONCLUSIONS: CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes.

Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Identification and control of two outbreaks of unrelated New Delhi metallo-ß-lactamase-producing carbapenem-resistant Escherichia coli traced to the same endoscope defect.

We report 2 outbreaks of genetically unrelated carbapenem-resistant New Delhi metallo-ß-lactamase-producing Escherichia coli caused by contaminated duodenoscopes. Using endoscopes with disposable end caps, adherence to the manufacturer's reprocessing instructions, routine audits, and manufacturer evaluation are critical in preventing such outbreaks.

ERCP with single-use disposable duodenoscopes in four different set-ups.

Endoscopic retrograde cholangiopancreatography (ERCP) has until now always been performed using a reusable non-sterile duodenoscope. The introduction of the new single-use disposable duodenoscope makes it possible to perform perioperative transgastric and rendezvous ERCP in an almost sterile manner. It also eliminates the risk of patient-to-patient transmission of infection in non-sterile settings. We present four patients who underwent different types of ERCP using a sterile single-use duodenoscope. This case report aims to demonstrate the use and the many potential advantages of the new disposable single-use duodenoscope in both sterile and non-sterile settings.