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.).

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.

Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Sequential endoscopist-driven phone calls improve the capture rate of adverse events after ERCP: a prospective study.

BACKGROUND AND AIMS: ERCP is a high-risk endoscopic procedure, yet reports of ERCP-related adverse events are largely limited to early adverse events based on immediate postprocedure assessment. We hypothesize that immediate/1-day follow-up underestimates the true adverse event rate, and later follow-up calls may enable a more accurate assessment of adverse events, leading to enhanced postprocedural patient care. METHODS: Consecutive patients undergoing ERCP at our tertiary care academic medical center from 2018 to 2019 were analyzed. Patients were encouraged to contact us with postprocedure symptoms, and they received phone calls at 1, 7, 14, and 30 days after the procedure using a standardized script to assess for delayed adverse events and unplanned health care encounters. RESULTS: This study is notable for a high rate of successful patient follow-up at day 1 (94%) and day 7 (93%). The overall adverse event rate was 1.9% immediately postprocedure, 3.3% on day 1, and 9.8% on day 7. Increased detection of adverse events was accomplished by the day 7 call relative to the day 1 call (pancreatitis 2% vs 0.5%; bleeding 0.5% vs 0.2%; infection 0.9% vs 0.5%). Follow-up calls at 14 and 30 days were lower yield for detection of post-ERCP adverse events. CONCLUSIONS: Initial postprocedure assessment and day 1 follow-up calls underestimate adverse event rates/unplanned health care encounters related to ERCP, due to delayed evolution of some adverse events. The day 7 call is optimal in that it resulted in a >3-fold higher rate of detection of adverse events and successful direction of over 10% of symptomatic patients to appropriate assessment and follow-up health care.

Quality metrics in the performance of EUS: a population-based observational cohort of the United States.

BACKGROUND AND AIMS: There are few data on the quality of EUS in the community setting. We characterized EUS performance at the individual facility level in 3 large American states, using need for repeat biopsy (NRB) as a metric for procedural failure, and the rate of unplanned hospital encounters (UHEs) as a metric for adverse events. METHODS: We collected data on 76,614 EUS procedures performed at 166 facilities in California, Florida, and New York (2009-2014). The endpoints for the study were 7-day rate of UHEs after EUS, and 30-day rate of NRB after EUS with fine-needle aspiration. Facility-level factors analyzed included annual procedure volume, urban/rural location, and free-standing status (facilities not attached to a larger hospital). Predictors for UHE and NRB were analyzed in both multivariable regression and nonparametric local regression. RESULTS: Facility volume did not predict risk for UHEs. However, high facility volume protected against NRB (P trend <.001) even after adjustment for other facility-level factors. When regressing facility volume against risk for NRB in local regression, a join point (inflection point) was identified at 97 procedures per annum. Once facilities reached this threshold volume, there appeared little additional protective effect of higher volume. Rural facility location (odds ratio, 1.81; 95% confidence interval, 1.36-2.40) and free-standing status (odds ratio, 1.57; 95% confidence interval, 1.16-2.13) were also associated with NRB. CONCLUSION: Facility volume does not predict risk for adverse events after EUS. However, high facility volume is associated with decreased rates of technical failure (as assessed by NRB). These data provide one of the first descriptions of EUS practice in community settings and highlight opportunities to improve endoscopic quality nationally.

Use of an Ultra-slim Gastroscope to Accomplish Endoscopist-Facilitated Rescue Intubation During ERCP: A Novel Approach to Enhance Patient and Staff Safety.

BACKGROUND: ERCP is often performed under monitored anesthesia care (MAC) rather than general anesthesia (GA), with patients positioned semi-prone on the fluoroscopy table. Rarely, a MAC ERCP must be converted to GA due to hypoxia or retained food in the stomach. In these circumstances, standard intubation is associated with a significant delay and potential for patient/staff injury during repositioning. We report a novel endoscopist-driven approach to intubation during ERCP using an ultra-slim, flexible gastroscope with an endotracheal tube backloaded onto it. MATERIALS AND METHODS: We identified patients who underwent ERCP from 2014 to 2019, and MAC to GA conversion events. Mode of intubation (standard vs. endoscopist-facilitated) and patient/procedure characteristics were evaluated. All endoscopist-facilitated intubations were performed under anesthesiologist supervision. RESULTS: A total of 3409 patients underwent ERCP; 1568 (46%) GA and 1841 (54%) MAC. Of these, 42 (2.3%) required intubation during ERCP and 16 underwent endoscopist-facilitated intubation due to retained food in the stomach and/or hypoxia. In 3 patients, aspirated material was suctioned from the trachea and bronchi using the ultra-slim gastroscope. Immediate post-procedure extubation was successful in all endoscopist-facilitated intubation patients and none exhibited radiographic evidence of aspiration pneumonia. CONCLUSIONS: Endoscopist-facilitated intubation using an ultra-slim flexible gastroscope is feasible and expeditious for MAC to GA conversion during ERCP. This technique is readily accomplished in the semi-prone position, while standard intubation requires patient transfer from fluoroscopy table to gurney, with associated delay/risks. These data suggest that further study of this approach is warranted, and this may be the most favorable approach for intubation during ERCP.

Goff Septotomy Is a Safe and Effective Salvage Biliary Access Technique Following Failed Cannulation at ERCP.

BACKGROUND: Biliary cannulation is readily achieved in > 85% of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). When standard cannulation techniques fail, salvage techniques utilized include the needle knife precut, double wire technique, and Goff septotomy. METHODS: Records of patients undergoing ERCP from 2005 to 2016 were retrospectively examined using a prospectively maintained endoscopy database. Patients requiring salvage techniques for biliary access were analyzed together with a control sample of 20 randomly selected index ERCPs per study year. Demographic and clinical variables including indications for ERCP, cannulation rates, and adverse events were collected. RESULTS: A total of 7984 patients underwent ERCP from 2005 to 2016. Biliary cannulation was successful in 94.9% of control index ERCPs, 87.2% of patients who underwent Goff septotomy (significantly higher than for all other salvage techniques, p ≤ 0.001), 74.5% of patients in the double wire group and 69.6% of patients in the needle knife precut group. Adverse event rates were similar in the Goff septotomy (4.1%) and index ERCP control sample (2.7%) groups. Adverse events were significantly higher in the needle knife group (27.2%) compared with all other groups. CONCLUSIONS: This study represents the largest study to date of Goff septotomy as a salvage biliary access technique. It confirms the efficacy of Goff septotomy and indicates a safety profile similar to standard cannulation techniques and superior to the widely employed needle knife precut sphincterotomy. Our safety and efficacy data suggest that Goff septotomy should be considered as the primary salvage approach for failed cannulation, with needle knife sphincterotomy restricted to Goff septotomy failures.

Unplanned Hospital Encounters After Endoscopic Retrograde Cholangiopancreatography in 3 Large North American States.

BACKGROUND & AIMS: We have few population-level data on the performance of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. We investigated the numbers of unplanned hospital encounters (UHEs), patient and facility factors associated with UHEs, and variation in quality and outcomes in the performance of ERCP in 3 large American states. METHODS: We collected data on 68,642 ERCPs, performed at 635 facilities in California, Florida, and New York from 2009 through 2014. The primary endpoint was number of UHEs with an ERCP-related event within 7 days of ERCP; secondary endpoints included number of UHEs within 30 days and mortality within 30 days. Each facility was assigned a risk-standardized cohort, and variations in number of UHEs were analyzed with multivariable analysis. RESULTS: Among all ERCPs, 5.8% resulted in a UHE within 7 days and 10.2% within 30 days. Performance of sphincterotomy was significantly associated with a higher risk of UHE at 7 and 30 days (P < .001). Younger age, female sex, and more advanced comorbidity were associated with UHE. There was substantial heterogeneity in rates of UHE among facilities: 4.2% at facilities in the 5th percentile and 25.2% at facilities in the 95th percentile. Increasing facility volume and ability to perform endoscopic ultrasonography were associated inversely with risk. The median number of ERCPs performed each year was 68.7, but 69% of facilities performed 100 or fewer ERCPs per year. Risk for UHE after sphincterotomy decreased with increasing facility volume until an inflection point of 157 ERCPs per year was reached. CONCLUSIONS: In an analysis of outcomes of 68,642 ERCPs performed in 3 states, we found a higher-than-expected number of UHEs. There is substantial unexplained variation in risk for adverse events after ERCPs among facilities, and volume is the strongest predictor of risk. Annual facility volumes above approximately 150 ERCPs per year may protect against UHE.

Triaging advanced GI endoscopy procedures during the COVID-19 pandemic: consensus recommendations using the Delphi method.

BACKGROUND AND AIMS: There is a lack of consensus on which GI endoscopic procedures should be performed during the COVID-19 pandemic, and which procedures could be safely deferred without having a significant impact on outcomes. METHODS: We selected a panel of 14 expert endoscopists. We identified 41 common indications for advanced endoscopic procedures from the ASGE Appropriate Use of GI Endoscopy guidelines. Using a modified Delphi method, we first achieved consensus on the patient-important outcome for each procedural indication. Panelists prioritized consensus patient-important outcome when categorizing each indication into one of the following 3 procedural time periods: (1) time-sensitive emergent (schedule within 1 week), (2) time-sensitive urgent (schedule within 1 to 8 weeks), and (3) non-time sensitive (defer for >8 weeks and then reassess the timing). Three anonymous rounds of voting were allowed before attempts at consensus were abandoned. RESULTS: All 14 invited experts agreed to participate in the study. The prespecified consensus threshold of 51% was achieved for assigning patient-important outcome(s) to each advanced endoscopy indication. The prespecified consensus threshold of 66.7% was achieved for 40 of 41 advanced endoscopy indications in stratifying them into 1 of 3 procedural time periods. For 12 of 41 indications, 100% consensus was achieved; for 20 of 41 indications, 75% to 99% consensus was achieved. CONCLUSIONS: By using a Modified Delphi method that prioritized patient-important outcomes, we developed consensus recommendations on procedural timing for common indications for advanced endoscopy. These recommendations and the structured decision framework provided by our study can inform decision making as endoscopy services are reopened.

Recent Trends and the Impact of the Affordable Care Act on Emergency Department Visits and Hospitalizations for Gastrointestinal, Pancreatic, and Liver Diseases.

BACKGROUND: The Affordable Care Act (ACA) with Medicaid expansion implemented in 2014, extended health insurance to >20-million previously uninsured individuals. However, it is unclear whether enhanced primary care access with Medicaid expansion decreased emergency department (ED) visits and hospitalizations for gastrointestinal (GI)/pancreatic/liver diseases. METHODS: We evaluated trends in GI/pancreatic/liver diagnosis-specific ED/hospital utilization over a 5-year period leading up to Medicaid expansion and a year following expansion, in California (a state that implemented Medicaid expansion) and compare these with Florida (a state that did not). RESULTS: From 2009 to 2013, GI/pancreatic/liver disease ED visits increased by 15.0% in California and 20.2% in Florida and hospitalizations for these conditions decreased by 2.6% in California and increased by 7.9% in Florida. Following Medicaid expansion, a shift from self-pay/uninsured to Medicaid insurance was seen California; in addition, a new decrease in ED visits for nausea/vomiting and GI infections, was evident, without associated change in overall ED/hospital utilization trends. Total hospitalization charges for abdominal pain, nausea/vomiting, constipation, and GI infection diagnoses decreased in California following Medicaid expansion, but increased over the same time-period in Florida. CONCLUSIONS: We observed a striking payer shift for GI/pancreatic/liver disease ED visits/hospitalizations after Medicaid expansion in California, indicating a shift in the reimbursement burden in self-pay/uninsured patients, from patients and hospitals to the government. ED visits and hospitalization charges decreased for some primary care-treatable GI diagnoses in California, but not for Florida, suggesting a trend toward lower cost of gastroenterology care, perhaps because of decreased hospital utilization for conditions amenable to outpatient management.

When Experts Fail: Use of a Short Turning Radius Colonoscope Facilitates Successful Completion of Colonoscopy in Patients with Bowel Fixity.

BACKGROUND: Rates of incomplete colonoscopy in non-expert settings range up to 13%. Expert colonoscopists can complete ~ 95% colonoscopies when other endoscopists fail; however, a small number remain incomplete even in expert hands, typically due to bowel fixity. AIMS: Pentax Retroview™ (EC-3490TLi) is a new slim colonoscope with a short turning radius (STR) and greater tip deflection (210°), which allows easy maneuverability across sharply angulated/fixed colonic bends. We evaluated the utility of this colonoscope for completing colonoscopies that fail even in the hands of expert colonoscopists. METHODS: Retrospective chart review was performed, and main outcomes measured included cecal intubation rate, lesions detected, dosage of sedation used, and complications. RESULTS: Using the STR colonoscope, complete colonoscopy to the cecum was possible in 34/37 patients (91.9%). No loss of lumen/blind advancement was necessary in any of the procedures. No adverse events occurred. Among the completed colonoscopies, 6/34 (17.6%) patients had adenomas, all proximal to the site of prior failure, including one advanced adenoma. All failures (n = 3, 8.1%) had a history of cancer surgeries, with peritoneal carcinomatosis/extensively fixed/frozen bowel (two patients) and an additional diverticular stricture with colo-vesical fistula (one patient). CONCLUSION: STR colonoscope facilitates completion of a high proportion (91.9%) of colonoscopies that previously failed in expert hands. Its STR allows easy maneuverability across segments of sharp angulation with bowel fixity without need for blind advancement. The use of this colonoscope led to the detection of adenomas in 17.6% of patients, all proximal to the site of prior failed colonoscopy.

Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography, From Training Through Independent Practice.

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.

Simethicone is retained in endoscopes despite reprocessing: impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values (with video).

BACKGROUND AND AIMS: Studies from our group and others demonstrate residual fluid in 42% to 95% of endoscope working channels despite high-level disinfection and drying. Additionally, persistent simethicone has been reported in endoscope channels despite reprocessing. METHODS: Endoscopy was performed by using water or varied simethicone concentrations (0.5%, 1%, 3%) for flushing. After high-level disinfection/drying, we inspected endoscope working channels for retained fluid by using the SteriCam borescope. Working channel rinsates were evaluated for adenosine triphosphate (ATP) bioluminescence. Fourier transform infrared spectroscopy was performed on fluid droplets gathered from a colonoscope in which low-concentration simethicone was used. RESULTS: Use of medium/high concentrations of simethicone resulted in a higher mean number of fluid droplets (13.5/17.3 droplets, respectively) and ATP bioluminescence values (20.6/23 relative light units [RLUs], respectively) compared with that of procedures using only water (6.3 droplets/10.9 RLUs; P < .001). Two automated endoscope reprocessing cycles resulted in return of a fluid droplet and ATP bioluminescence values to ranges similar to that of procedures that used only water (P = .56). Low-concentration simethicone did not increase the mean residual fluid or ATP bioluminescence values compared with procedures that used only water (5.8 droplets/15.6 RLUs). Fourier transform infrared analysis revealed simethicone in the endoscope working channel after use of low-concentration simethicone. CONCLUSIONS: Use of medium/high concentrations of simethicone is associated with retention of increased fluid droplets and higher ATP bioluminescence values in endoscope working channels, compared with endoscopes in which water or low concentration simethicone was used. However, simethicone is detectable in endoscopes despite reprocessing, even when it is utilized in low concentrations. Our data suggest that when simethicone is used, it should be used in the lowest concentration possible. Facilities may consider 2 automated endoscope reprocessor cycles for reprocessing of endoscopes when simethicone has been used.

Comparison of automated and manual drying in the elimination of residual endoscope working channel fluid after reprocessing (with video).

BACKGROUND AND AIMS: Residual fluid within endoscope working channels after reprocessing may promote growth of pathogens. Current reprocessing guidelines therefore recommend endoscope drying with administration of forced filtered air; however, the duration and modality of administered air are not specified. The new DriScope Aid device enables automated administration of filtered air at controlled pressure through all internal endoscope channels. We systematically compared, for the first time, the impact of manual drying and automated drying on retained working channel fluid and bioburden after reprocessing. METHODS: We assessed for residual working channel fluid after reprocessing and/or drying by using the SteriCam borescope. Drying was performed either manually (forced filtered air) or was automated (DriScope Aid) for either 5 or 10 minutes. Adenosine triphosphate (ATP) bioluminescence testing was performed on working channel rinsates after drying, to evaluate for residual bioburden. RESULTS: Significantly more fluid droplets were evident after manual drying (4.55 ± 6.14) than with automated device-facilitated drying for either 5 minutes (0.83 ± 1.29; P = .007) or 10 minutes (0 ± 0; P = .001). ATP bioluminescence values were higher for manual drying compared with automated drying at 48 hours (P = .001) and 72 hours (P = .014) after reprocessing. CONCLUSIONS: We demonstrate significantly fewer water droplets and delayed ATP bioluminescence values within endoscope working channels after automated drying compared with manual drying. In particular, virtually no retained fluid was evident within endoscope working channels after automated drying for 10 minutes. These findings support recommendations for automation of as many reprocessing steps as possible. Automated drying may decrease the risk of transmission of infection related to endoscopy.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Radiation Training, Radiation Protection, and Fluoroscopy Utilization Practices Among US Therapeutic Endoscopists.

BACKGROUND: Fluoroscopy use during ERCP exposes patients and providers to deleterious effects of radiation. Formal training in fluoroscopy/radiation protection is not widely emphasized during therapeutic endoscopy training, and radiation use during GI endoscopy has not previously been characterized in the USA. In this study, we evaluated radiation training, fluoroscopy use patterns, and radiation protection practices among US therapeutic endoscopists. METHODS: An anonymous electronic survey was distributed to US therapeutic endoscopists, and responses were analyzed using descriptive statistics. State-specific requirements for fluoroscopy utilization were determined from state radiologic health branches. RESULTS: A total of 159 endoscopists (response rate 67.8%) predominantly those working in university hospitals (69.2%) with > 5 years of experience performing ERCP (74.9%) completed the questionnaire. Although the majority of endoscopists (61.6%) reported that they personally controlled fluoroscopy during ERCP, most (56.6%) had not received training on operating their fluoroscopy system. Only a minority (18-31%) of all respondents reported consistently utilizing modifiable fluoroscopy system parameters that minimize patient radiation exposure (pulsed fluoroscopy, frame rate modification or collimation). Endoscopists appear to undertake adequate personal radiation protective measures although use of a dosimeter was not consistent in half of respondents. The majority of states (56.8%) do not have any stated requirement for certification of non-radiologist physicians who intend to operate fluoroscopy. CONCLUSIONS: Most US gastroenterologists performing ERCP have not received formal training in operating their fluoroscopy system or in minimizing radiation exposure to themselves and to their patients. Such formal training should be included in all therapeutic endoscopy training programs, and fluoroscopy system-specific training should be offered at all hospitals.

Practice Patterns for Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography for Patients With Choledocholithiasis.

BACKGROUND & AIMS: Cholecystectomy (CCY) after an episode of choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction reduces recurrent biliary events compared to expectant management. We studied practice patterns for performance of CCY after ERCP for choledocholithiasis using data from 3 large states and evaluated the effects of delaying CCY. METHODS: We conducted a retrospective cohort study using the ambulatory surgery, inpatient, and emergency department databases from the states of California (years 2009-2011), New York (2011-2013), and Florida (2012-2014). We collected data from 4516 patients hospitalized with choledocholithiasis who underwent ERCP. We compared outcomes of patients who underwent CCY at index admission (early CCY), elective CCY within 60 days of discharge (delayed CCY), or did not undergo CCY (no CCY), calculating rate of recurrent biliary events (defined as an emergency department visit or unplanned hospitalization due to symptomatic cholelithiasis, cholecystitis, choledocholithiasis, cholangitis, or biliary pancreatitis), mortality, and cost by CCY cohort. We also evaluated risk factors for not undergoing CCY. The primary outcome measure was the rate of recurrent biliary events in the 365 days after discharge from index admission. RESULTS: Of the patients who underwent ERCP for choledocholithiasis, 41.2% underwent early CCY, 10.9% underwent delayed CCY, and 48.0% underwent no CCY. Early CCY reduced relative risk of recurrent biliary events within 60 days by 92%, compared with delayed or no CCY (P < .001). After 60 days following discharge from index admission, patients with early CCY had an 87% lower risk of recurrent biliary events than patients with no CCY (P < .001) and patients with delayed CCY had an 88% lower risk of recurrent biliary events than patients with no CCY (P < .001). A strategy of delayed CCY performed on an outpatient basis was least costly. Performance of early CCY was inversely associated with low facility volume. Hispanic race, Asian race, Medicaid insurance, and no insurance associated inversely with performance of delayed CCY. CONCLUSIONS: In a retrospective analysis of >4500 patients hospitalized with choledocholithiasis, we found that CCY was not performed after ERCP for almost half of the cases. Although early and delayed CCY equally reduce the risk of subsequent recurrent biliary events, patients are at 10-fold higher risk of recurrent biliary event while waiting for a delayed CCY compared with patients who underwent early CCY. Delayed CCY is a cost-effective strategy that must be balanced against the risk of loss to follow-up, particularly among patients who are ethnic minorities or have little or no health insurance.

Effects of a Brief Educational Program on Optimization of Fluoroscopy to Minimize Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND & AIMS: Fluoroscopy during endoscopic retrograde cholangiopancreatography (ERCP) is increasingly performed by therapeutic endoscopists, many of whom have not received formal training in modulating fluoroscopy use to minimize radiation exposure. Exposure to ionizing radiation has significant health consequences for patients and endoscopists. We aimed to evaluate whether a 20-minute educational intervention for endoscopists would improve use of fluoroscopy and decrease ERCP-associated exposure to radiation for patients. METHODS: We collected data from 583 ERCPs, performed in California from June 2010 through November 2012; 331 were performed at baseline and 252 following endoscopist education. The educational intervention comprised a 20-minute video explaining best practices for fluoroscopy, coupled with implementation of a formal fluoroscopy time-out protocol before the ERCP was performed. Our primary outcome was the effect of the educational intervention on direct and surrogate markers of patient radiation exposure associated with ERCPs performed by high-volume endoscopists (HVEs) (200 or more ERCPs/year) vs low-volume endoscopists (LVEs) (fewer than 200 ERCPs/year). RESULTS: At baseline, total radiation dose and dose area product were significantly higher for LVEs, but there was no significant difference between HVEs and LVEs following education. Education was associated with significant reductions in median fluoroscopy time (48% reduction for HVEs vs 30% reduction for LVEs), total radiation dose (28% reduction for HVEs vs 52% for LVEs) and dose area product (35% reduction for HVEs vs 48% reduction for LVEs). All endoscopists significantly increased their use of low magnification and collimation following education. CONCLUSIONS: A 20-minute educational program with emphasis on ideal use of modifiable fluoroscopy machine settings results in an immediate and significant reduction in ERCP-associated patient radiation exposure for low-volume and high-volume endoscopists. Training programs should consider radiation education for advanced endoscopy fellows.

Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).

BACKGROUND AND AIMS: Outbreaks of transmission of infection related to endoscopy despite reported adherence to reprocessing guidelines warrant scrutiny of all potential contributing factors. Recent reports from ambulatory surgery centers indicated widespread significant occult damage within endoscope working channels, raising concerns regarding the potential detrimental impact of this damage on the adequacy of endoscope reprocessing. METHODS: We inspected working channels of all 68 endoscopes at our academic institution using a novel flexible inspection endoscope. Inspections were recorded and videos reviewed by 3 investigators to evaluate and rate channel damage and/or debris. Working channel rinsates were obtained from all endoscopes, and adenosine triphosphate (ATP) bioluminescence was measured. RESULTS: Overall endoscope working channel damage was rated as minimal and/or mild and was consistent with expected wear and tear (median 1.59 on our 5-point scale). Our predominant findings included superficial scratches (98.5%) and scratches with adherent peel (76.5%). No channel perforations, stains, or burns were detected. The extent of damage was not predicted by endoscope age. Minor punctate debris was common, and a few small drops of fluid were noted in 42.6% of endoscopes after reprocessing and drying. The presence of residual fluid predicted higher ATP bioluminescence values. The presence of visualized working channel damage or debris was not associated with elevated ATP bioluminescence values. CONCLUSION: The flexible inspection endoscope enables high-resolution imaging of endoscope working channels and offers endoscopy units an additional modality for endoscope surveillance, potentially complementing bacterial cultures and ATP values. Our study, conducted in a busy academic endoscopy unit, indicated predominately mild damage to endoscope working channels, which did not correlate with elevated ATP values.

Liver transplant-related anastomotic biliary strictures: a novel, rapid, safe, radiation-sparing, and cost-effective management approach.

BACKGROUND AND AIMS: Biliary strictures after orthotopic liver transplantation (OLT) are typically managed by sequential ERCP procedures, with incremental dilation of the stricture and stent exchange (IDSE) and placement of new stents. This approach resolves >80% of strictures after 12 months but requires costly, lengthy ERCPs with significant patient radiation exposure. Increasing awareness of the harmful effects of radiation, escalating healthcare costs, and decreasing reimbursement for procedures mandate maximal efficiency in performing ERCP. We compared the traditional IDSE protocol with a sequential stent addition (SSA) protocol, in which additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation. METHODS: Patients undergoing ERCP for OLT-related anastomotic strictures from 2010 to 2016 were identified from a prospectively maintained endoscopy database. Procedure duration, fluoroscopy time, stricture resolution rates, adverse events, materials fees, and facility fees were analyzed for IDSE and SSA procedures. RESULTS: Seventy-seven patients underwent 277 IDSE and 132 SSA procedures. Mean fluoroscopy time was 64.5% shorter (P < .0001) and mean procedure duration 41.5% lower (P < .0001) with SSA compared with IDSE. SSA procedures required fewer accessory devices, resulting in significantly lower material (63.8%, P < .0001) and facility costs (42.8%, P < .0001) compared with IDSE. Stricture resolution was >95%, and low adverse event rates did not significantly differ. CONCLUSIONS: SSA results in shorter, cost-effective procedures requiring fewer accessory devices and exposing patients to less radiation. Stricture resolution rates are equivalent to IDSE, and adverse events do not differ significantly, even in this immunocompromised population.