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.).

Clinical and technical outcomes of patients undergoing endoscopic ultrasound-guided gastroenterostomy using 20-mm vs. 15-mm lumen-apposing metal stents.

BACKGROUND: Most studies on endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) for palliation of malignant gastric outlet obstruction (GOO) utilized a 15-mm lumen-apposing metal stent (LAMS). More recently, a 20-mm LAMS has become available. This study aimed to compare rates of technical and clinical success and adverse events (AEs) in patients undergoing EUS-GE using a 20-mm vs. 15-mm LAMS. METHODS: Patients who underwent EUS-GE with 15-mm or 20-mm LAMS for malignant GOO during the period from January 2018 to October 2020 were included. The primary outcome was clinical success, defined as an increase in the gastric outlet obstruction score (GOOS) by at least 1 point during follow-up. Secondary outcomes were technical success, maximum tolerated diet, re-intervention rate, and rate/severity of AEs. RESULTS: 267 patients (mean age 67 years, 43 % women) with malignant GOO from 19 centers underwent EUS-GE. Clinical success rates were similar for the 15-mm and 20-mm stents (89.2 % [95 %CI 84.2 %-94.2 %] vs. 84.1 % [77.4%-90.6 %], respectively). However, a significantly higher proportion of patients in the 20-mm group tolerated a soft solid/complete diet at the end of follow-up (91.2 % [84.4 %-95.7 %] vs. 81.2 % [73.9 %-87.2 %], P = 0.04). Overall, AEs occurred in 33 patients (12.4 % [8.4 %-16.3 %]), with similar rates for 15-mm and 20-mm stents (12.8 % [7.5 %-18.2 %] vs. 11.8 % [6 %-17.6 %]), including incidence of severe/fatal AEs (2 % [0.4 %-5.8 %] vs. 3.4 % [0.9 %-8.4 %]). CONCLUSIONS: The 20-mm and 15-mm LAMS show similar safety and efficacy for patients undergoing EUS-GE for malignant GOO. The 20-mm LAMS allows a more advanced diet and is, thus preferred for EUS-GE.

Novel rigidizing overtube for colonoscope stabilization and loop prevention (with video).

BACKGROUND AND AIMS: Loop formation can impede endoscope advancement, destabilize the tip, and cause pain. Strategies to mitigate looping include torque-based reduction maneuvers, variable stiffness shafts, and abdominal splinting. In some cases, these strategies are insufficient, and there is need for novel instruments. Loop formation is of particular concern in colonoscopy, but it can also impact performance of other endoscopic procedures such as enteroscopy and altered-anatomy ERCP. In this case series we demonstrate the utility of a novel rigidizing overtube (Pathfinder; Neptune Medical, Burlingame, Calif, USA) in colonoscopy and other endoscopic procedures where loop management is critical. METHODS: We describe our initial experience with the Pathfinder overtube in 29 patients. The overtube is 85 cm long and can accommodate a pediatric colonoscope. In its native state, the overtube is extremely flexible. Once the overtube is advanced to the desired location, application of a vacuum to the device causes the device to become 15 times stiffer. The endoscope can then be advanced through the overtube without loop formation in the region that the overtube traverses. RESULTS: The overtube was used in 29 patients to assist with difficult procedures. Patients were predominantly men (n = 18; 62.1%), with a median age of 66 years (interquartile range, 57-72). One patient received an upper endoscopy (3.4%), 24 received colonoscopy (82.8%), and 4 received enteroscopy (13.8%). The overtube was used in 12 procedures for incomplete colonoscopy (41.4%), 6 for depth (20.7%), and 11 for stability (37.9%). Colonoscopy was performed in the setting of screening (n = 3), surveillance given polyp history (n = 7), referrals for polyp removal (n = 10), workup of iron deficiency anemia (n = 2), and incomplete colonoscopy (n = 1). The lower endoscopy cases had a median cecal intubation time of 5 minutes (interquartile range, 4.25-7). Enteroscopy was performed in 4 patients: In one patient the distal 60 cm of the ileum was examined with a pediatric colonoscope to exclude ileitis, in another the overtube was used to stabilize a 6-mm endoscope to traverse a tight Crohn's ileocolonic stricture, in a third patient altered-anatomy ERCP was performed using an enteroscope through the overtube to reach a hepaticojejunostomy, and in the final patient upper enteroscopy was performed and the mid-jejunum was reached. We present 4 cases that demonstrate the use of the overtube. There were no adverse events. CONCLUSIONS: Initial experience with a novel rigidizing overtube suggests that this tool can be useful in colonoscopy and other endoscopic procedures affected by looping.

Enhanced EUS imaging (with videos).

BACKGROUND AND AIMS: EUS remains a primary diagnostic tool for the evaluation of pancreaticobiliary disease. Although EUS combined with FNA or biopsy sampling is highly sensitive for the diagnosis of neoplasia within the pancreaticobiliary tract, limitations exist in specific clinical settings such as chronic pancreatitis. Enhanced EUS imaging technologies aim to aid in the detection and diagnosis of lesions that are commonly evaluated with EUS. METHODS: We reviewed technologies and methods for enhanced imaging during EUS and applications of these methods. Available data regarding efficacy, safety, and financial considerations are summarized. RESULTS: Enhanced EUS imaging methods include elastography and contrast-enhanced EUS (CE-EUS). Both technologies have been best studied in the setting of pancreatic mass lesions. Robust data indicate that neither technology has adequate specificity to serve as a stand-alone test for pancreatic malignancy. However, there may be a role for improving the targeting of sampling and in the evaluation of peritumoral lymph nodes, inflammatory pancreatic masses, and masses with nondiagnostic FNA or fine-needle biopsy sampling. Further, novel applications of these technologies have been reported in the evaluation of liver fibrosis, pancreatic cysts, and angiogenesis within neoplastic lesions. CONCLUSIONS: Elastography and CE-EUS may improve the real-time evaluation of intra- and extraluminal lesions as an adjunct to standard B-mode and Doppler imaging. They are not a replacement for EUS-guided tissue sampling but provide adjunctive diagnostic information in specific clinical situations. The optimal clinical use of these technologies continues to be a focus of ongoing research.

Endoscopic ultrasound-guided gastroenterostomy using an oroenteric catheter-assisted technique: a retrospective analysis.

BACKGROUND : This study evaluated an oroenteric catheter (OEC)-assisted technique to distend the enteric loop for endoscopic ultrasound-guided gastroenterostomy (EUS-GE) in patients with gastric outlet obstruction (GOO). METHODS : Patient outcomes were reviewed. Proximal enteric loops were filled with water via an OEC (7 Fr or 8 Fr), providing a target for EUS-GE using a lumen-apposing metal stent (15-mm caliber). Clinical success was defined as toleration of a non-liquid diet by Day 3. RESULTS : 42 patients (mean age 73.1 [SEM 2.8] years; 23 male) underwent EUS-GE for malignant (n = 37) and benign (n = 5) duodenal strictures. EUS-GE creation was successful in 41/42 (98 %), with mean procedure time of 36 (SEM 3) minutes and no serious complications. Clinical success was achieved in 39/42 (93 %) at 5.7 (SEM 2.6) months' follow-up. Of 14 patients who died, 13 (93 %) maintained oral intake until death. EUS-GE provided good symptom relief in all 28 surviving patients until follow-up. CONCLUSIONS : OEC-assisted EUS-GE provided satisfactory relief of GOO symptoms, with high technical success (98 %) and no serious complications.

Techniques and devices for the endoscopic treatment of gastroparesis (with video).

BACKGROUND AND AIMS: Gastroparesis is a symptomatic chronic disorder of the stomach characterized by delayed gastric emptying in the absence of mechanical obstruction. Several endoscopic treatment modalities have been described that aim to improve gastric emptying and/or symptoms associated with gastroparesis refractory to dietary and pharmacologic management. METHODS: In this report we review devices and techniques for endoscopic treatment of gastroparesis, the evidence regarding their efficacy and safety, and the financial considerations for their use. RESULTS: Endoscopic modalities for treatment of gastroparesis can be broadly categorized into pyloric, nonpyloric, and nutritional therapies. Pyloric therapies such as botulinum toxin injection, stent placement, pyloroplasty, and pyloromyotomy specifically focus on pylorospasm as a therapeutic target. These interventions aim to reduce the pressure gradient across the pyloric sphincter, with a resultant improvement in gastric emptying. Nonpyloric therapies, such as venting gastrostomy and gastric electrical stimulation, are intended to improve symptoms. Nutritional therapies, such as feeding tube placement, aim to provide nutritional support. CONCLUSIONS: Several endoscopic interventions have shown utility in improving the quality of life and symptoms of select patients with refractory gastroparesis. Methods to identify which patients are best suited for a specific treatment are not well established. Endoscopic pyloromyotomy is a relatively recent development that may prove to be the preferred pyloric-directed intervention, although additional and longer-term outcomes are needed.

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos).

BACKGROUND AND AIMS: As the prevalence of obesity continues to rise, increasing numbers of patients undergo bariatric surgery. Management of adverse events of bariatric surgery may be challenging and often requires a multidisciplinary approach. Endoscopic intervention is often the first line of therapy for management of these adverse events. This document reviews technologies and techniques used for endoscopic management of adverse events of bariatric surgery, organized by surgery type. METHODS: The MEDLINE database was searched through May 2018 for articles related to endoscopic management of adverse events of bariatric interventions by using relevant keywords such as adverse events related to "gastric bypass," "sleeve gastrectomy," "laparoscopic adjustable banding," and "vertical banded sleeve gastroplasty," in addition to "endoscopic treatment" and "endoscopic management," among others. Available data regarding efficacy, safety, and financial considerations are summarized. RESULTS: Common adverse events of bariatric surgery include anastomotic ulcers, luminal stenoses, fistulae/leaks, and inadequate initial weight loss or weight regain. Devices used for endoscopic management of bariatric surgical adverse events include balloon dilators (hydrostatic, pneumatic), mechanical closure devices (clips, endoscopic suturing system, endoscopic plication platform), luminal stents (covered esophageal stents, lumen-apposing metal stents, plastic stents), and thermal therapy (argon plasma coagulation, needle-knives), among others. Available data, composed mainly of case series and retrospective cohort studies, support the primary role of endoscopic management. Multiple procedures and techniques are often required to achieve clinical success, and existing management algorithms are evolving. CONCLUSIONS: Endoscopy is a less invasive alternative for management of adverse events of bariatric surgery and for revisional procedures. Endoscopic procedures are frequently performed in the context of multidisciplinary management with bariatric surgeons and interventional radiologists. Treatment algorithms and standards of practice for endoscopic management will continue to be refined as new dedicated technology and data emerge.

Devices and techniques for endoscopic treatment of residual and fibrotic colorectal polyps (with videos).

BACKGROUND AND AIMS: Residual neoplasia after macroscopically complete EMR of large colon polyps has been reported in 10% to 32% of resections. Often, residual polyps at the site of prior polypectomy are fibrotic and nonlifting, making additional resection challenging. METHODS: This document reviews devices and methods for the endoscopic treatment of fibrotic and/or residual polyps. In addition, techniques reported to reduce the incidence of residual neoplasia after endoscopic resection are discussed. RESULTS: Descriptions of technologies and available outcomes data are summarized for argon plasma coagulation ablation, snare-tip coagulation, avulsion techniques, grasp-and-snare technique, EndoRotor endoscopic resection system, endoscopic full-thickness resection device, and salvage endoscopic submucosal dissection. CONCLUSIONS: Several technologies and techniques discussed in this document may aid in the prevention and/or resection of fibrotic and nonlifting polyps.

Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopic transoral outlet reduction (TORe) has been used to manage weight regain after Roux-en-Y gastric bypass. We conducted a meta-analysis to summarize the efficacy and safety of the two most commonly used techniques: full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe). METHODS: A literature search of publication databases was performed from their inception to February 2020 for relevant studies. The outcomes of interest were percentage total body weight loss, gastrojejunal anastomosis (GJA) diameter, and adverse events (AEs). The pooled effect estimates were analyzed using a random-effects model. Meta-regression was conducted to identify associations between GJA diameter and weight loss. RESULTS: Nine ft-TORe (n = 737) and 7 APMC-TORe (n = 888) studies were included. APMC-TORe was performed as a series of sessions (mean number of sessions ranging from 1.2 to 3), whereas ft-TORe was mostly performed as a single session. Percentage total body weight loss was 8.0% (95% confidence interval [CI], 6.3%-9.7%), 9.5% (95% CI, 8.1%-11.0%), and 5.8% (95% CI, 4.3%-7.1%) after ft-TORe and 9.0% (95% CI, 4.1%-13.9%), 10.2% (95% CI, 8.4%-12.1%), and 9.5% (95% CI, 5.7%-13.2%) after APMC-TORe at 3, 6, and 12 months, respectively, with no weight-loss difference at 3 and 6 months (P > .05). Only one severe AE was observed after APMC-TORe and none after ft-TORe. Stricture formation was the most common AE (ft-TORe 3.3% and APMC-TORe 4.8%, P = .38). All were successfully treated by endoscopic dilation or conservative treatment. Smaller aperture of the post-TORe GJA and greater change in the GJA diameter correlated with greater weight loss in APMC-TORe and numerical trends in ft-TORe. CONCLUSIONS: This meta-analysis demonstrates that both ft-TORe and APMC-TORe offer significant and comparable weight-loss outcomes with a high and comparable safety profile. However, APMC-TORe typically required multiple endoscopic sessions. Identifying a goal for the final and change in GJA diameter could be useful treatment targets.

Effectiveness of combination endoscopic therapy for colonic anastomotic leaks.

BACKGROUND: Colonic anastomotic leaks are associated with significant morbidity and mortality. Whereas small case series suggest that fully covered self-expandable metal stents (FCSEMS) are effective, no larger studies have examined the impact of combination endoscopic therapy on colonic anastomotic leaks. METHODS: Our retrospective cohort study reviewed 51 patients undergoing endoscopic therapy for colonic anastomotic leaks between 2011 and 2018. Patients receiving combination therapy involving FCSEMS plus local closure (n = 24) were compared with patients receiving FCSEMS alone (n = 18) or endoscopic suturing alone (n = 9). The primary outcomes were technical and clinical success (resolution of leak, removal of percutaneous drains, avoidance of surgical reoperation, and reversal of temporary diversion). RESULTS: Clinical success was achieved in 55 % of patients. Clinical success was achieved in 18/24 patients (75 %) with combination therapy compared with 6/18 patients receiving FCSEMS alone (33 %, adjusted risk ratio [RR] 2.16, 95 % confidence interval [CI] 1.10 - 4.24; P = 0.02) and 4 /9 patients undergoing endoscopic suturing alone (44 %, RR 1.91, 95 %CI 0.84 - 4.31; P = 0.10). Stent migration occurred in 40 % of patients. CONCLUSIONS: This large series demonstrates that combination therapy was associated with a higher rate of clinical success, and future prospective studies are warranted.

Endoscopic simulators.

BACKGROUND AND AIMS: Simulation refers to educational tools that allow for repetitive instruction in a nonpatient care environment that is risk-free. In GI endoscopy, simulators include ex vivo animal tissue models, live animal models, mechanical models, and virtual reality (VR) computer simulators. METHODS: After a structured search of the peer-reviewed medical literature, this document reviews commercially available GI endoscopy simulation systems and clinical outcomes of simulation in endoscopy. RESULTS: Mechanical simulators and VR simulators are frequently used early in training, whereas ex vivo and in vivo animal models are more commonly used for advanced endoscopy training. Multiple studies and systematic reviews show that simulation-based training appears to provide novice endoscopists with some advantage over untrained peers with regard to endpoints such as independent procedure completion and performance time, among others. Data also suggest that simulation training may accelerate the acquisition of specific technical skills in colonoscopy and upper endoscopy early in training. However, the available literature suggests that the benefits of simulator training appear to attenuate and cease after a finite period. Further studies are needed to determine if meeting competency metrics using simulation will predict actual clinical competency. CONCLUSIONS: Simulation training is a promising modality that may aid in endoscopic education. However, for widespread incorporation of simulators into gastroenterology training programs to occur, simulators must show a sustained advantage over traditional mentored teaching in a cost-effective manner. Because most studies evaluating simulation have focused on novice learners, the role of simulation training in helping practicing endoscopists gain proficiency using new techniques and devices should be further explored.

Advances in the diagnosis and surveillance of Barrett's esophagus (with videos).

BACKGROUND AND AIMS: Most patients diagnosed with esophageal adenocarcinoma do not carry a known diagnosis of Barrett's esophagus (BE), suggesting that an improved approach to screening may potentially be of benefit. The use of dysplasia as a biomarker and random biopsy protocols for its detection has limitations. In addition, detecting and appropriately classifying dysplasia in patients with known BE can be difficult. METHODS: This document reviews several technologies with a recently established or potential role in the diagnosis and/or surveillance of BE as well as risk stratification for progression to esophageal adenocarcinoma. RESULTS: Two technologies were reviewed for imaging or tissue sampling: (1) wide-area transepithelial sampling and (2) volumetric laser endomicroscopy. Four technologies were reviewed for molecular and biomarker technologies for diagnosis and risk stratification: (1) Cytosponge, (2) mutational load, (3) fluorescence in situ hybridization, and (4) immunohistochemistry. CONCLUSION: Several technologies discussed in this document may improve dysplasia detection in BE in a wide-field manner. Moreover, the addition of different biomarkers may aid in enhanced risk stratification to optimize approaches to surveillance or treatment for patients with BE.

Inspection of endoscope instrument channels after reprocessing using a prototype borescope.

BACKGROUND AND AIMS: Visual inspection of the instrument channel has been proposed as a quality assurance step during endoscope reprocessing. However, the nature and severity of findings in a broad array of endoscopes (gastroscopes, colonoscopes, duodenoscopes, and echoendoscopes) after systemic implementation of an inspection protocol remain unknown. In addition, a study using borescope inspection in upper endoscopes and colonoscopes raised concerns about persistent simethicone residue despite full reprocessing. METHODS: A pilot inspection study using a prototype borescope (SteriCam Inspection Scope; SteriView Inc, San Rafael, Calif) was performed on routinely used endoscopes after high-level disinfection, manual forced-air dry of the instrument channel, and overnight vertical storage. Video recordings 1.5 to 2 minutes in duration were reviewed for visible moisture, debris, discoloration, scratches, channel shredding (scratches that result in strips or filaments of the channel lining protruding into the lumen), and visible evidence of biofilm or simethicone residue. RESULTS: A total of 97 inspections of 59 endoscopes were reviewed. The most common finding was scratches, seen in 51 devices (86%). Channel shredding was found in 35 devices (59%). Intrachannel debris was identified in 22 (23%) of the 97 inspections. No moisture was seen (0%) in the 74 inspections performed after forced-air dry and overnight vertical storage compared with moisture in 5 of 18 inspections (28%) performed after storage alone. No visual evidence of biofilm or simethicone residue was discovered despite its frequent use in our unit. CONCLUSION: Internal defects of the instrument channel appear to occur frequently. Manual forced-air drying of the channel appears to be highly effective in eliminating moisture compared with overnight hang drying alone. Video inspection of the endoscope channel may be useful to audit reprocessing performance and to identify damaged endoscopes.

Duodenoscope reprocessing practice patterns in U.S. endoscopy centers: a survey study.

BACKGROUND AND AIMS: After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing 1 or more of 4 enhanced reprocessing measures in addition to updated manual cleaning methods and high-level disinfection (HLD). The implementation of these techniques in endoscopy facilities and provider opinions regarding reprocessing priorities remain unknown. METHODS: Physicians, nurse managers, nurses, and infection control staff at endoscopy units performing ERCP in the United States were surveyed to assess current institutional practices and individual opinions regarding future reprocessing solutions. RESULTS: A total of 249 distinct institutions participated in the survey. Of these, 223 (89.6%) implemented at least 1 of the 4 supplemental reprocessing methods after MDRO outbreaks. Overall, 63% of centers used repeat HLD, 53% performed surveillance microbiological culturing, 35% used liquid chemical sterilization, and 12% used ethylene oxide sterilization. Thirty-seven centers (15%) routinely screened patients for MDRO. Forced-air drying after reprocessing was used by 47.8% of centers. Fifty percent of individual respondents, including 58.6% of physicians, believed that redesign of the duodenoscope is the best long-term reprocessing solution. The majority (55.1%) identified efficacy to be the single most important factor in selecting a reprocessing technique. CONCLUSIONS: Although most endoscopy centers have implemented enhanced duodenoscope reprocessing techniques, there is a large variation in practice. Most providers believe that duodenoscope redesign and identifying reprocessing techniques with maximal efficacy are the long-term priorities. Improved adherence to forced-air drying in duodenoscope reprocessing is needed.

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study.

BACKGROUND & AIMS: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers. METHODS: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly. RESULTS: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training. CONCLUSIONS: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416.

Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes.

BACKGROUND AND AIMS: The duodenoscopes used to perform ERCP have been implicated in several outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) infection. The risk factors for CRE transmission via contaminated duodenoscopes remain unclear. METHODS: In this retrospective, single-center, case-control study, all patients who underwent ERCP with either 1 of 2 contaminated duodenoscopes were evaluated. We compared the patients who acquired CRE (active infection or colonization) with those who did not. RESULTS: Between October 3, 2014, and January 28, 2015, a total of 125 procedures were performed on 115 patients by using either of the contaminated duodenoscopes. Culture data were available for 104 of the 115 exposed patients (90.4%). Among these patients, 15 (14.4%) became actively infected (n = 8, 7.7%) or colonized (n = 7, 6.7%) with CRE. On univariate analysis, recent antibiotic exposure (66.7% vs 37.1%; P = .046), active inpatient status (60.0% vs 28.1%; P = .034), and a history of cholangiocarcinoma (26.7% vs 3.4%; P = .008) were patient characteristics associated with an increased risk of CRE infection. Biliary stent placement (53.3% vs 22.5%; P = .024) during ERCP was a significant procedure-related risk factor. After adjusting for cholangiocarcinoma, biliary stent placement (odds ratio 3.62; 95% confidence interval, 1.12-11.67), and active inpatient status (odds ratio 3.74; 95% confidence interval, 1.15-12.12) remained independent risk factors for CRE transmission. CONCLUSIONS: In patients undergoing ERCP with a contaminated duodenoscope, biliary stent placement, a diagnosis of cholangiocarcinoma, and active inpatient status are associated with an increased risk of CRE transmission.

Variation in learning curves and competence for ERCP among advanced endoscopy trainees by using cumulative sum analysis.

BACKGROUND AND AIMS: There are limited data on learning curves and competence in ERCP. By using a standardized data collection tool, we aimed to prospectively define learning curves and measure competence among advanced endoscopy trainees (AETs) by using cumulative sum (CUSUM) analysis. METHODS: AETs were evaluated by attending endoscopists starting with the 26th hands-on ERCP examination and then every ERCP examination during the 12-month training period. A standardized ERCP competency assessment tool (using a 4-point scoring system) was used to grade the examination. CUSUM analysis was applied to produce learning curves for individual technical and cognitive components of ERCP performance (success defined as a score of 1, acceptable and unacceptable failures [p1] of 10% and 20%, respectively). Sensitivity analyses varying p1 and by using a less-stringent definition of success were performed. RESULTS: Five AETs were included with a total of 1049 graded ERCPs (mean ± SD, 209.8 ± 91.6/AET). The majority of cases were performed for a biliary indication (80%). The overall and native papilla allowed cannulation times were 3.1 ± 3.6 and 5.7 ± 4, respectively. Overall learning curves demonstrated substantial variability for individual technical and cognitive endpoints. Although nearly all AETs achieved competence in overall cannulation, none achieved competence for cannulation in cases with a native papilla. Sensitivity analyses increased the proportion of AETs who achieved competence. CONCLUSION: This study demonstrates that there is substantial variability in ERCP learning curves among AETs. A specific case volume does not ensure competence, especially for native papilla cannulation.