Initial experience with duodenoscopes with single-use end caps in pediatric endoscopic retrograde cholangiopancreatography: infection prevention comes at a cost.

BACKGROUND AND AIMS: Duodenoscopes with single-use end caps were introduced to minimize infection risk, but they are unstudied in pediatrics. METHODS: We collected clinical data and endoscopists' evaluations of duodenoscopes with single-use end caps versus reusable duodenoscopes over 18 months. RESULTS: A total of 106 ERCPs were performed for patients aged 1 to 18 (mean, 14.2) years. Forty-six involved single-use end caps, with 9 requiring crossover to reusable duodenoscopes. ERCPs involving single-use end caps resulted in more instances of mucosal trauma (10 vs 0; P < .05) and post-ERCP pancreatitis (4 vs 1; P < .05) and accounted for 8 of 9 ERCPs requiring advanced cannulation techniques. No post-ERCP infections occurred. Reported challenges included single-use end cap stiffness and difficulty with their alignment for cannulation. CONCLUSIONS: We report difficulty with advancement, greater reliance on advanced cannulation techniques, and higher rates of post-ERCP pancreatitis when using duodenoscopes with single-use end caps in pediatric ERCP. This area warrants further study.

Adverse Events of Endoscopic Clip Placement: A MAUDE Database Analysis.

BACKGROUND: Clips are endoscopic mechanical devices with tensile and closure strength that can approximate tissue and provide hemostasis through a tamponade effect. Clips are ubiquitously used in endoscopic practice, and numerous studies have validated the clinical efficacy of clips, with recent guidelines recommending them as a first-line intervention for recurrent and persistent nonvariceal gastrointestinal bleeding. However, the safety profile for these devices has yet to be delineated, thus, we aim to investigate this feature by examining the adverse events reported to the Food and Drug Administration. METHODS: Postmarketing surveillance data from the Food and Drug Administration Manufacturer And User Facility Device Experience database were analyzed from January 2012 to January 2021. The Manufacturer And User Facility Device Experience database is a reporting software and does not independently verify the details of complications. RESULTS: Two thousand five hundred forty reports were issued, of which 287 were patient adverse events and 2766 were device problems. Activation, separation, and positioning issues were most common. No consequences or clinically significant impact on patients were seen in 1968 reports. Foreign bodies were seen in 97 cases, hemorrhage in 57 cases, tissue damage in 42 cases, embedded clips in tissues/plaques in 16 cases, perforation in 15 cases, lacerations in 6 cases, and infection in 3 cases. CONCLUSIONS: While the most commonly reported device problems involved activation, separation, and positioning, most patients were clinically unaffected. Moreover, perforation and infection were exceedingly rare, further highlighting the safety profile of endoscopic clips.

Outcomes of ERCP in Patients With Cystic Fibrosis: A Nationwide Inpatient Assessment.

BACKGROUND: Cystic fibrosis (CF) is a multisystem disorder that leads to abnormal transport of chloride and sodium across secretory epithelia resulting in thickened, viscous secretions in the bronchi, biliary tract, pancreas, intestine, and the reproductive system. Defects in the biliary tract can predispose to stone formation requiring endoscopic retrograde cholangiopancreatography (ERCP). However, there is a paucity of data assessing ERCP outcomes in patients with CF. METHODS: We identified patients from the Healthcare Cost and Utilization Project (HCUP)-National Inpatient Sample (NIS) between the years 2016 and 2020. Our study group included patients with CF of all ages who underwent an inpatient ERCP. We used ICD10 diagnostic and procedural codes to identify patients, procedures, and complications of the procedure. RESULTS: From 2016 to 2020, a total of 860,679 inpatient ERCPs were identified. Of these procedures, 535 (0.06%) were performed in patients with CF. The mean age of patients with CF undergoing ERCP was 60.62 years, of which 48% were males and 52% were females. Patients in the CF group had a higher incidence of post-ERCP pneumothorax (0.93%) than the patients in the non-CF group (0.15%). The occurrence of other ERCP-related adverse events was similar in both groups (P>0.05). On multivariate regression analysis, patients with CF were 1.75 times more likely to develop post-ERCP infections [odds ratio (OR): 1.75; 95% CI: 1.03-2.94; P=0.035) and 7.64 times more likely to develop post-ERCP pneumothorax (OR: 7.64; 95% CI: 1.03-56.5; P=0.046) compared to patients without CF after adjusting for confounders. The groups had no significant difference in mortality, post-ERCP pancreatitis, bleeding, perforation, pneumoperitoneum, and gas embolism. There was also no significant difference in the length of stay between the study and control groups. CONCLUSIONS: ERCP is a safe procedure in patients with CF with a comparable risk of postprocedural complications and mortality to those who do not have cystic fibrosis. However, patients with CF may experience a higher risk of post-ERCP infections and post-ERCP pneumothorax. Further studies are needed to prospectively evaluate outcomes of ERCP in patients with CF and to determine methods of mitigating adverse events.

Pediatric ERCP: Evolving into an Outpatient Procedure.

BACKGROUND: While most adult ERCPs are performed on an outpatient basis, pediatric ERCPs are typically performed on an inpatient basis, or with ERCP followed by at least one night inpatient admission. We have begun performing a substantial proportion of our pediatric ERCPs on an outpatient basis, using our clinical judgment to guide the decision process. In the present study, we compare patient characteristics, indications, and adverse events associated with outpatient vs. inpatient ERCP. METHODS: Using our endoscopy database, we identified patients 18 years of age and under who underwent ERCP from 2019 to 2021. Demographics, hospitalization status, indications, findings, interventions, as well as available adverse event and clinical outcomes data were analyzed. RESULTS: 147 ERCP procedures were performed during the study period by one of two interventional endoscopists. A subset of 51 (34.7%) patients underwent outpatient ERCP. Comparison of the two groups (outpatient vs. inpatient ERCP) was notable for no statistically significant difference in patient age, range of indications, or proportion of index vs. subsequent ERCP. Overall rates of ERCP-associated adverse events were low and there was no statistically significant difference between adverse events in patients who underwent outpatient vs. inpatient ERCP. CONCLUSION: We analyzed outpatient and inpatient pediatric ERCP patient demographics and ERCP characteristics to identify factors that guide decision to determine whether pediatric ERCPs are performed on an outpatient vs. inpatient basis. There was no significant difference in adverse events associated with outpatient vs. inpatient pediatric ERCPs, attesting to the safety of outpatient ERCP for this subset of patients in the studied context. This is an area worthy of future prospective and multi-center study.

Advanced trainee perceptions of disposable duodenoscopes and disposable endcaps: results of a nationwide survey.

INTRODUCTION: Disposable duodenoscopes and duodenoscopes with disposable endcaps are being used in clinical practice to reduce or eliminate the risk of transmitting infections. The study aim was to assess perceptions and experiences regarding the use of these duodenoscopes among advanced endoscopy fellows in a nationally representative sample. METHODS: A 17-item electronic survey was sent to 74 advanced endoscopy training programs. The survey was completed by 50 participants and their responses were included for analysis. RESULTS: Most participants were from academic training programs (82.7%) and identified as being in their 7th year of post graduate training (92%; PGY-7). Participants performed an average of 414 ERCPs. 29% reported difficulty with cannulation using disposable duodenoscopes versus 15.7% with duodenoscopes with disposable endcaps (vs. standard duodenoscope). 96% of trainees perceived disposable duodenoscopes as not cost effective and 92% stated they would not use this device during independent practice. 100% of trainees stated that they would use duodenoscopes with disposable endcaps during independent practice. For their most challenging cases, 90% of trainees preferred using standard reprocessable duodenoscopes while no trainee indicated they would prefer using a disposable duodenoscope in this scenario. 82% of participants stated that disposable duodenoscopes and disposable endcaps should be used exclusively or preferentially for high-risk patients citing cost, functionality, and concerns regarding environmental impact. DISCUSSION: Advanced endoscopy fellows perceive disposable duodenoscopes as impacting technical maneuverability. Concerns about functionality, cost effectiveness and environmental impact are barriers to adoption.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Safety and efficacy of minor papillotomy in children and adolescents with pancreas divisum.

INTRODUCTION: Pancreas Divisum (PD) is a common pancreatic ductal variant which is twice as common in pediatric patients with acute recurrent pancreatitis (ARP) relative to the general population (14% vs. 7%). Endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy has been performed to facilitate drainage of pancreatic juice from the diminutive minor papilla to prevent pancreatitis and pancreatic damage. METHODS: We searched our prospectively-maintained endoscopy databases for patients 18 and younger who underwent ERCP with minor papillotomy between 2009 and 2019. Demographic data, indications, procedural interventions and findings, as well as available clinical outcomes data were analyzed. RESULTS: 54 ARP/PD patients underwent ERCP with minor papillotomy. Median age was 14 (range 7-18) years, and 26 (48.1%) patients were female. Post-ERCP pancreatitis developed in 10/54 patients (18.5%). 12-month post-ERCP clinical trajectory was available in 47/54 (87%) patients and most patients (38/47, 80.8%) improved clinically after minor papillotomy, with 9/47 (19.1%) experiencing resolution of pancreatitis episodes and none indicated worsening severity or frequency of pancreatitis episodes following ERCP. CONCLUSION: The majority of children and adolescents with PD and ARP who underwent ERCP with minor papillotomy experienced subjective improvement in their symptoms following the intervention. These data suggest that ERCP with minor papillotomy for pediatric patients with PD and ARP is beneficial and may be curative in a subset of patients-higher rates of improvement than have been previously reported in adults.

Preclinical safety evaluation of calcineurin inhibitors delivered through an intraductal route to prevent post-ERCP pancreatitis demonstrates endocrine and systemic safety.

OBJECTIVE: There is an urgent need for safe and targeted interventions to mitigate post-ERCP pancreatitis (PEP). Calcineurin inhibitors (CnIs) offer therapeutic promise as calcineurin signaling within acinar cells is a key initiating event in PEP. In previous proof-of-concept studies using experimental models, we showed that concurrent intra-pancreatic ductal administration of the CnIs, tacrolimus (Tac) or cyclosporine A (CsA) with the ERCP radiocontrast agent (RC) prevented PEP. To translate this finding clinically, we investigated potential toxic effects of intraductal delivery of a single-dose RC-CnI formulation on endocrine pancreas function and systemic toxicities in a preclinical PEP model. METHODS: C57BL/6J mice underwent ductal cannulation and received a single, intra-pancreatic ductal infusion of RC or RC with Tac or CsA (treatment groups) or underwent ductal cannulation without infusion ('sham' group). To assess endocrine function, intraperitoneal glucose tolerance test (IPGTT) was performed at two days before infusion and on day 2 and 14 post-surgery. To evaluate off-target tissue toxicities, renal and hepatic function-related parameters including blood urea nitrogen, plasma creatinine, potassium, aspartate aminotransferase, alanine aminotransferase, and total bilirubin were measured at the same time-points as IPGTT. Histological and biochemical indicators of pancreas injury and inflammation were also evaluated. RESULTS: No abnormalities in glucose metabolism, hepatic or renal function were observed on day 2 or 14 in mice administered with intraductal RC or RC with Tac or CsA. CONCLUSION: Intraductal delivery of RC-CnI formulation was safe and well-tolerated with no significant acute or subacute endocrine or systemic toxicities, underscoring its clinical utility to prevent PEP.

Rectal administration of tacrolimus protects against post-ERCP pancreatitis in mice.

OBJECTIVE: There is an unmet clinical need for effective, targeted interventions to prevent post-ERCP pancreatitis (PEP). We previously demonstrated that the serine-threonine phosphatase, calcineurin (Cn) is a critical mediator of PEP and that the FDA-approved calcineurin inhibitors, tacrolimus (Tac) or cyclosporine A, prevented PEP. Our recent observations in preclinical PEP models demonstrating that Cn deletion in both pancreatic and hematopoietic compartments is required for maximal pancreas protection, highlighted the need to target both systemic and pancreas-specific Cn signaling. We hypothesized that rectal administration of Tac would effectively mitigate PEP by ensuring systemic and pancreatic bioavailability of Tac. We have tested the efficacy of rectal Tac in a preclinical PEP model and in cerulein-induced experimental pancreatitis. METHODS: C57BL/6 mice underwent ductal cannulation with saline infusion to simulate pressure-induced PEP or were given seven, hourly, cerulein injections to induce pancreatitis. To test the efficacy of rectal Tac in pancreatitis prevention, a rectal Tac suppository (1 mg/kg) was administered 10 min prior to cannulation or first cerulein injection. Histological and biochemical indicators of pancreatitis were evaluated post-treatment. Pharmacokinetic parameters of Tac in the blood after rectal delivery compared to intravenous and intragastric administration was evaluated. RESULTS: Rectal Tac was effective in reducing pancreatic injury and inflammation in both PEP and cerulein models. Pharmacokinetic studies revealed that the rectal administration of Tac helped achieve optimal blood levels of Tac over an extended time compared to intravenous or intragastric delivery. CONCLUSION: Our results underscore the effectiveness and clinical utility of rectal Tac for PEP prophylaxis.

Prospective randomized comparison of endoscopist-facilitated endotracheal intubation and standard intubation for ERCP.

BACKGROUND AND AIMS: Complex endoscopic procedures are increasingly performed with anesthesia support, which substantially affects endoscopy unit efficiency. ERCP performed with the patient under general anesthesia presents unique challenges, as patients are typically first intubated, then transferred to the fluoroscopy table and positioned semi-prone. This requires additional time and staff while increasing the potential for patient/staff injury. We have developed the technique of endoscopist-facilitated intubation using an endotracheal tube backloaded onto an ultra-slim gastroscope as a potential solution to these issues and evaluated its utility prospectively. METHODS: Sequential patients undergoing ERCP were randomized to undergo endoscopist-facilitated intubation or to standard intubation. Demographic data, patient/procedure characteristics, endoscopy efficiency parameters, and adverse events were analyzed. RESULTS: During the study period, 45 ERCP patients were randomized to undergo either endoscopist-facilitated intubation (n = 23) or standard intubation (n = 22). Endoscopist-facilitated intubation was successful in all patients, with no hypoxic events. Median time from patient arrival in room to procedural start was shorter in patients undergoing endoscopist-facilitated intubation versus standard intubation (8.2 vs 29 minutes, P < .0001). Endoscopist-facilitated intubations were brisker than standard intubations (.63 vs 2.85 minutes, P < .0001). Patients undergoing endoscopist-facilitated intubation reported less postprocedure throat discomfort (13% vs 50%, P < .01) and fewer myalgia incidences (22% vs 73%, P < .01) than patients undergoing standard intubation. CONCLUSIONS: Endoscopist-facilitated intubation was technically successful in every patient. Median endoscopist-facilitated intubation time from patient arrival in room to procedural start was 3.5-fold lower, and median endoscopist-facilitated intubation time was >4-fold lower, than for standard intubation. Endoscopist-facilitated intubation significantly enhanced endoscopy unit efficiency and minimized staff and patient injury. General adoption of this novel approach may represent a paradigm shift in the approach to safe and efficient intubation of all patients requiring general anesthesia. Although the results of this controlled trial are promising, larger studies in a broad population are needed to validate these findings. (Clinical trial registration number: NCT03879720.).

Best Practices in Pancreatico-biliary Stenting and EUS-guided Drainage.

Indications for endoscopic placement of endoluminal and transluminal stents have greatly expanded over time. Endoscopic stent placement is now a well-established approach for the treatment of benign and malignant biliary and pancreatic diseases (ie, obstructive jaundice, intra-abdominal fluid collections, chronic pancreatitis etc.). Ongoing refinement of technical approaches and development of novel stents is increasing the applicability and success of pancreatico-biliary stenting. In this review, we discuss the important developments in the field of pancreatico-biliary stenting, with a specific focus on endoscopic retrograde cholangiopancreatography and endoscopic ultrasound-associated developments.

Pediatric Endoscopy Blocks: Enhanced Efficiency and Endoscopist Satisfaction.

OBJECTIVES: Endoscopic procedures are increasingly performed for children and adolescents and these interventions represent a central element of both pediatric gastroenterology (GI) care and revenues. It remains unclear, however, which scheduling paradigm maximizes efficiency of resource utilization and delivery of care in this arena. In this study, we evaluate the impact of shifting from shared endoscopy blocks to individual, provider-specific endoscopy blocks for scheduling endoscopic procedures in our tertiary care academic center. METHODS: The implemented endoscopy block system involves a single endoscopist performing procedures in an allocated room for the entire half-day period of time, with most providers having 1-3.5 day blocks per month. We analyzed block fragmentation (multiple providers in a single block), block utilization, and procedure volume, comparing the 8-month period prior to implementation of the block system (pre-implementation period) with the 8-month period following implementation of the block system (post-implementation period). Provider satisfaction and perceptions were assessed by survey pre- and post-implementation. Standard descriptive statistics were utilized for analysis. RESULTS: In the pre- and post-implementation periods, 22 half-day blocks were allocated to pediatric GI. In the pre-implementation period, mean utilization of these blocks was 65.9% (range: 47%-77%). In the post-implementation period, mean % utilization was 79.8% (range: 64%-89%). Overall endoscopy procedure volume increased from 279 in the pre-implementation period to 419 in the post-implementation period. Provider perception of endoscopy efficiency was enhanced by the block system, with 68.4% of pediatric GI respondents rating endoscopy as "efficient" post-implementation (vs 19% pre-implementation) and 63.2% indicating that the block system directly enhanced efficiency. A total of 63.2% reported increased personal procedure volume and 84.2% reported perceived increase in overall procedure volume with block system implementation. CONCLUSIONS: Strategic approaches for scheduling endoscopic procedures carry the potential to enhance efficiency and experience for both providers and patients. Implementation of the endoscopy block system was associated with increased procedure volumes and block utilization as well as a more positive experience for the majority of providers. Schedule adjustments with analysis of associated efficiency and satisfaction metrics can optimize pediatric endoscopy practice.

Influence of Frailty in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Biliary Stone Disease: A Nationwide Study.

BACKGROUND AND AIMS: Pancreaticobiliary diseases are common in the elderly. To this end, frailty represents a state of vulnerability that should be considered when assessing the risks and benefits of therapeutic endoscopic procedures. We aim to determine the rate of readmissions and clinical outcomes using the validated Hospital Frailty Risk Score in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Using the National Readmissions Database, we identified patients with an admission diagnosis of cholangitis with obstructive stone from 2016 to 2019. Patients were determined to be of low frailty risk with a score of < 5, while patients of medium to high frailty risk had a score of > 5. RESULTS: During the study period, 5751 patients were identified with acute cholangitis with obstructing stone. Mean age of index admissions was 69.4 years and 51.8% were female. From the total cohort, 5119 (89.2%) patients underwent therapeutic ERCP, 38.0% (n = 1947) of whom were regarded as frail (risk score > 5). Following ERCP, frail patients had a less but statistically insignificant readmission rate compared to non-frail patients (2.76% vs 4.05%, p = 0.450). However, compared to non-frail patients, frail patients experienced higher post-ERCP complications (6.20% vs 14.63%, p < 0.001). Frail patients were more likely to have longer lengths of stay, higher hospital cost, and mortality risk. CONCLUSION: ERCP is not a risk factor for readmission among frail patients. However, frail patients are at higher risk for procedure-related complications, healthcare utilization, and mortality.

Clinical insights into drug-associated pancreatic injury.

PURPOSE OF REVIEW: Drug-induced pancreatitis is one of the top three causes of acute pancreatitis. A drug exposure is traditionally determined to be the cause of pancreatitis only after other possible and common causes of pancreatitis have been excluded. RECENT FINDINGS: In this review, we challenge this traditional notion of drug-induced pancreatitis as a diagnosis of exclusion. Instead, we propose to shift the paradigm of conceptualizing what we term drug-associated pancreatic injury (DAPI); as a continuum of pancreatic injury that can be concomitant with other risk factors. The aims of this targeted review are to harness recent literature to build a foundation for conceptualizing DAPI, to highlight specific drugs associated with DAPI, and to describe a framework for future studies of DAPI. SUMMARY: Our hope is that probing and characterizing the mechanisms underlying the various types of DAPI will lead to safer use of the DAPI-inducing drugs by minimizing the adverse event of pancreatitis.

A review of the rationale for the testing of the calcineurin inhibitor tacrolimus for post-ERCP pancreatitis prevention.

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed for the management of pancreaticobiliary disorders. The most troublesome ERCP-associated adverse event is post-ERCP pancreatitis (PEP), which occurs in up to 15% of all patients undergoing ERCP. A substantial body of preclinical data support a mechanistic rationale for calcineurin inhibitors in preventing PEP. The findings are coupled with recent clinical data suggesting lower rates of PEP in patients who concurrently use the calcineurin inhibitor tacrolimus (e.g., solid organ transplant recipients). In this review, we will firstly summarize data in support of testing the use of tacrolimus for PEP prophylaxis, either in combination with rectal indomethacin or by itself. Secondly, we propose that administering tacrolimus through the rectal route could be favorable for PEP prophylaxis over other routes of administration.

Rectal INdomethacin, oral TacROlimus, or their combination for the prevention of post-ERCP pancreatitis (INTRO Trial): Protocol for a randomized, controlled, double-blinded trial.

BACKGROUND: Acute pancreatitis remains the most common and morbid complication of endoscopic retrograde cholangiopancreatography (ERCP). The use of rectal indomethacin and pancreatic duct stenting has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP), but these interventions have limitations. Recent clinical and translational evidence suggests a role for calcineurin inhibitors in the prevention of pancreatitis, with multiple retrospective case series showing a reduction in PEP rates in tacrolimus users. METHODS: The INTRO trial is a multicenter, international, randomized, double-blinded, controlled trial. A total of 4,874 patients undergoing ERCP will be randomized to receive either oral tacrolimus (5 mg) or oral placebo 1-2 h before ERCP, and followed for 30 days post-procedure. Blood and pancreatic aspirate samples will also be collected in a subset of patients to quantify tacrolimus levels. The primary outcome of the study is the incidence of PEP. Secondary endpoints include the severity of PEP, ERCP-related complications, adverse drug events, length of hospital stay, cost-effectiveness, and the pharmacokinetics, pharmacodynamics, and pharmacogenomics of tacrolimus immune modulation in the pancreas. CONCLUSIONS: The INTRO trial will assess the role of calcineurin inhibitors in PEP prophylaxis and develop a foundation for the clinical optimization of this therapeutic strategy from a pharmacologic and economic standpoint. With this clinical trial, we hope to demonstrate a novel approach to PEP prophylaxis using a widely available and well-characterized class of drugs. TRIAL REGISTRATION: NCT05252754, registered on February 14, 2022.

Cost utility analysis of strategies for minimizing risk of duodenoscope-related infections.

BACKGROUND AND AIMS: Transmission of multidrug-resistant organisms by duodenoscopes during ERCP is problematical. The U.S. Food and Drug Administration recently recommended transitioning away from reusable fixed-endcap duodenoscopes to those with innovative device designs that make reprocessing easier, more effective, or unnecessary. Partially disposable (PD) duodenoscopes with disposable endcaps and fully disposable (FD) duodenoscopes are now available. We assessed the relative cost of approaches to minimizing infection transmission, taking into account duodenoscope-transmitted infection cost. METHODS: We developed a Monte Carlo analysis model in R (R Foundation for Statistical Computing, Vienna, Austria) with a multistate trial framework to assess the cost utility of various approaches: single high-level disinfection (HLD), double HLD, ethylene oxide (EtO) sterilization, culture and hold, PD duodenoscopes, and FD duodenoscopes. We simulated quality-adjusted life years (QALYs) lost by duodenoscope-transmitted infection and factored this into the average cost for each approach. RESULTS: At infection transmission rates <1%, PD duodenoscopes were most favorable from a cost utility standpoint in our base model. The FD duodenoscope minimizes the potential for infection transmission and is more favorable from a cost utility standpoint than use of reprocessable duodenoscopes after single or double HLD at all infection rates, EtO sterilization for infection rates >.32%, and culture and hold for infection rates >.56%. Accounting for alternate scenarios of variation in hospital volume, QALY value, post-ERCP lifespan, and environmental cost shifted cost utility profiles. CONCLUSIONS: Our model indicates that PD duodenoscopes represent the most favorable option from a cost utility standpoint for ERCP, with anticipated very low infection transmission rates and a low-cost disposable element. These data underscore the importance of cost calculations that account for the potential for infection transmission and associated patient morbidity/mortality.

Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps.

BACKGROUND AND AIMS: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval. METHODS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. RESULTS: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common. CONCLUSIONS: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events.

Applicability, efficacy, and safety of over-the-scope clips in children.

BACKGROUND AND AIMS: Over-the-scope clips (OTSCs) are now becoming popular in endoscopy performed in adults for indications such as acute nonvariceal GI bleeding, anastomotic bleeding, and for closure of gastrocutaneous and postgastrostomy fistulae. Varied sizes of clip are available, but even the smallest, 8.5 to 9.8 mm in diameter with its loading device on the tip of the endoscope, increases device and endoscope intubation diameters up to 14.65 mm. This may present challenges in terms of the size of the patient in whom it might be used. OTSCs appear to be effective and safe in the hands of those who are trained appropriately in endoscopy on adult patients; however, the experience of OTSC application in children is not reported. Here we present results of a service evaluation of this technology at 2 regional/national referral pediatric endoscopy units in the United Kingdom and the United States. METHODS: Two tertiary centers' databases were searched to identify cases in which OTSCs were used. Demographics, presentation, anthropometry, comorbidities, efficacy, adverse events, and postprocedure follow-up were recorded, with identification of resolution or recurrence. RESULTS: OTSC procedures were performed on 24 occasions in 20 patients (11 girls) between February 2018 and February 2021. Patients had a mean age of 12 years (range, 5-17) and a mean weight of 44.42 kg (range, 18.2-70.3). Indications were nonhealing PEG site fistulae (n = 7), acute nonvariceal upper GI bleeding (ANUGIB) from gastric ulcers (5), ANUGIB from duodenal ulcers (3), nonhealing bleeding anastomotic ulcer (3), esophageal mucocutaneous fistula (1), and gastric perforation (1). Technical success was achieved in all but 1 case (95%), and clinical success was achieved in 18 cases (90%). CONCLUSIONS: The OTSC device appears to be effective in children (minimum age 5 years and minimum weight 18 kg) in a limited number of situations including anastomotic ulcer, closure of leaking PEG site, gastric perforation, and bleeding peptic ulcers. The operator should be an experienced endotherapeutic endoscopist with specific OTSC training, and the type and size of the OTSC device should be carefully considered, along with any comorbidities of the patient that may preclude success and/or lead to potential adverse events such as esophageal perforation.

Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).