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.
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.
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.
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.
Background and Aims The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to ...compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution. Methods This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression. Results A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) ( P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts ( P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) ( P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03). Conclusions TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs.
Background and Aims The role of endoscopic submucosal dissection (ESD) in Barrett’s early neoplasia is not well defined, with most studies originating from Asia and Europe. We aimed to assess the ...efficacy, safety, and results of ESD in Barrett’s esophagus (BE) with high-grade dysplasia (HGD) and early adenocarcinoma (EAC) across centers in the United States. Methods Multicenter retrospective analysis on 46 patients with BE who underwent ESD for BE-HGD or EAC, or both, between January 2010 and April 2015. The primary endpoint was the rate of en bloc resection. Secondary aims included rate of R0 (complete) and curative resection, a comparison of pre- and post-ESD histology, procedure-related adverse events, and rate of remission at follow-up. Results Median age was 69 years (range, 42-82 years). The median resected specimen size was 45 mm (range, 13-125 mm). En bloc and curative resection rates were 96% (44/46) and 70% (32/46), respectively. Most lesions (11/20; 55%) diagnosed as BE-HGD on biopsy were upstaged to intramucosal or invasive EAC on post-ESD histopathology. There were 4 early (<48 hours) adverse events (3 bleeding and 1 perforation), and all were treated endoscopically. Seven patients (15%) developed esophageal strictures that were managed endoscopically. Complete remission of BE neoplasia was found in 100% (32/32) of patients with curative resection at median follow-up of 11 months (range, 2-25 months). Conclusions This is the largest multicenter series of ESD for early neoplastic BE from the United States. ESD appears to be safe and effective, with high en bloc and curative resection rates in the treatment of early BE neoplasia.
Abstract Background Antithrombotic therapy for acute myocardial infarction (MI) with atrial fibrillation (AF) among higher risk older patients treated with percutaneous coronary intervention (PCI) ...remains unclear. Objectives This study sought to determine appropriate antithrombotic therapy for acute MI patients with AF treated with PCI. Methods We examined 4,959 patients ≥65 years of age with acute MI and AF who underwent coronary stenting (Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines). The primary effectiveness outcome was 2-year major adverse cardiac events (MACE) comprising death, readmission for MI, or stroke; the primary safety outcome was bleeding readmission. Outcomes with dual antiplatelet therapy (DAPT) or triple therapy (DAPT plus warfarin) were compared using Cox proportional hazard modeling with inverse probability-weighted propensity adjustment. Results Among 4,959 patients, 27.6% (n = 1,370) were discharged on triple therapy. Relative to DAPT, patients on triple therapy had a similar risk of MACE (adjusted hazard ratio HR: 0.99 95% confidence interval (CI): 0.86 to 1.16) but significantly greater risk of bleeding requiring hospitalization (adjusted HR: 1.61 95% CI: 1.31 to 1.97) and greater risk of intracranial hemorrhage (adjusted HR: 2.04 95% CI: 1.25 to 3.34). Of 1,591 Medicare Part D patients, 90-day post-discharge warfarin persistence among patients discharged on warfarin was 93.2% (n = 412). Results of 90-day landmark analyses comparing triple therapy versus DAPT in patients persistently on warfarin versus those not discharged on warfarin who had not filled a warfarin prescription were similar to our primary findings. Conclusions Approximately 1 in 4 older AF patients undergoing PCI for MI were discharged on triple therapy. Those receiving triple therapy versus DAPT had higher rates of major bleeding without a measurable difference in composite MI, death, or stroke.
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.
Background Cholangiocarcinoma (CCA) is a malignancy with a poor 5-year survival rate (5%-10%). ERCP-directed radiofrequency ablation (RFA) or photodynamic therapy (PDT) can be performed as palliative ...therapy for unresectable CCA. ERCP with PDT is associated with improved survival compared with stent placement alone. However, ERCP-directed RFA has not been directly compared with PDT in patients with CCA. Objective To compare overall survival in patients with unresectable CCA who underwent palliative ERCP-directed RFA versus PDT. Design Retrospective cohort study. Setting Tertiary-care academic medical center. Patients Forty-eight patients with unresectable CCA who underwent ERCP-directed ablative therapy for palliation of unresectable CCA. Interventions ERCP-directed RFA or PDT. Main Outcome Measurements Overall survival by Kaplan-Meier analysis after initial treatment with either RFA or PDT. Results Patients who underwent RFA (n = 16) demonstrated an overall survival similar to that of those who underwent PDT (n = 32), with a median survival of 9.6 versus 7.5 months, respectively ( P = .799). Patient age ( P = .45), sex ( P = .52), and lead time ( P = .59) from presentation to initial RFA or PDT had no significant association with survival. The presence of distant metastasis was inversely associated with survival (hazard ratio 3.55; 95% confidence interval, 1.29-9.77; P = .014). Patients who underwent RFA (compared with PDT) had a lower mean number of plastic stents placed per month (0.45 vs 1.10, P = .001) but also had more episodes of stent occlusion (0.06 vs 0.02, P = .008) and cholangitis (0.13 vs 0.05, P = .008) per month. Limitations Retrospective, single-center design. Conclusions Survival after ERCP-directed RFA and PDT was not statistically different in patients with unresectable CCA. A randomized, controlled trial is warranted to validate these preliminary results.
Background and Aims EUS-guided FNA or biopsy sampling is widely practiced. Optimal sonographic visualization of the needle is critical for image-guided interventions. Of the several commercially ...available needles, bench-top testing and direct comparison of these needles have not been done to reveal their inherent echogenicity. The aims are to provide bench-top data that can be used to guide clinical applications and to promote future device research and development. Methods Descriptive bench-top testing and comparison of 8 commonly used EUS-FNA needles (all size 22 gauge): SonoTip Pro Control (Medi-Globe); Expect Slimline (Boston Scientific); EchoTip, EchoTip Ultra, EchoTip ProCore High Definition (Cook Medical); ClearView (Conmed); EZ Shot 2 (Olympus); and BNX (Beacon Endoscopic), and 2 new prototype needles, SonoCoat (Medi-Globe), coated by echogenic polymers made by Encapson. Blinded evaluation of standardized and unedited videos by 43 EUS endoscopists and 17 radiologists specialized in GI US examination who were unfamiliar with EUS needle devices. Results There was no significant difference in the ratings and rankings of these needles between endosonographers and radiologists. Overall, 1 prototype needle was rated as the best, ranking 10% to 40% higher than all other needles ( P < .01). Among the commercially available needles, the EchoTip Ultra needle and the ClearView needle were top choices. The EZ Shot 2 needle was ranked statistically lower than other needles (30%-75% worse, P < .001). Conclusions All FNA needles have their inherent and different echogenicities, and these differences are similarly recognized by EUS endoscopists and radiologists. Needles with polymeric coating from the entire shaft to the needle tip may offer better echogenicity.
Abstract Background There are conflicting data regarding the relationship between the number of modifiable traditional risk factors and prognosis in acute coronary syndromes (ACS). This controversy ...might in part be explained by the differential use of prehospital medications. Methods Using data from the Canadian, multicentre Global Registry of Acute Coronary Events (GRACE) (1999-2008), we stratified 13,686 ACS patients into 3 groups (0, 1-2, vs 3-4 risk factors) and compared their baseline characteristics, in-hospital treatments, and outcomes. Multivariable logistic regressions were performed to adjust for the components of the GRACE risk score and preadmission statin and acetylsalicylic acid (ASA) use. Results Among these patients (ST-elevation myocardial infarction 28.3%), 14.5%, 62.6%, and 22.9% had 0, 1-2, and 3-4 risk factors, respectively. Patients with fewer risk factors were less likely to be on ASA, statin, and other prehospital medications. Unadjusted in-hospital mortality was significantly different across risk factor groups (4.9%, 3.0%, and 3.1% for 0, 1-2, and 3-4 risk factor groups, respectively, P for trend = 0.002). This difference was no longer significant after adjusting for the components of the GRACE risk score ( P for trend = 0.088) and further adjusting for preadmission statin and ASA use ( P for trend = 0.96). For in-hospital mortality, there was no significant interaction between risk factor categories and ACS type ( P = 0.26). Conclusions The lower mortality observed in patients with ACS with more risk factors may be partially attributed to the protective effect of prehospital ASA and statin use. The number of risk factors does not provide incremental prognostic value beyond the validated GRACE risk score.
Background In patients with surgically altered anatomy, ERCP is often unsuccessful. Single-balloon enteroscopy (SBE) enables deep intubation of the small bowel, permitting diagnostic and therapeutic ...ERCP in this subset of patients. Objective To determine the effectiveness of SBE in performing endoscopic retrograde cholangiography (ERC) in patients with surgically altered anatomy. Design Case series. Setting Large quaternary-care center. Patients Thirteen patients (11 women) underwent 16 SBE procedures with ERCP. Patient anatomy consisted of Whipple (n = 3), hepaticojejunostomy (n = 3), Billroth II (n = 1), and Roux-en-Y (n = 9). Interventions Patients with surgically altered anatomy in whom standard ERCP techniques had failed or were not possible underwent ERC by using SBE with initial therapeutic intent. Main Outcome Measurements Success rates of diagnostic ERC and therapeutic ERC in those patients who required biliary intervention. Procedure-related complications were also assessed. Results Diagnostic ERC was successful 12 (92.3%) of 13 patients and in 13 (81.3%) of 16 cases. Therapeutic ERC was required in 10 patients in whom diagnostic ERC was first accomplished, and therapeutic ERC was successful in 9 (90%) of 10 patients. Biliary interventions included balloon dilation (n = 4), stone extraction (n = 2), sphincterotomy (n = 4), removal of a surgically placed stent (n = 3), and stenting (n = 2). Two patients developed pancreatitis after therapeutic ERC. Median follow-up was 53 days (range 22-522 days). Overall procedural success in an intent-to-treat analysis by case was 75%. Limitation Single-center experience. Conclusion SBE enables diagnostic and therapeutic ERC in most patients with altered anatomy. SBE-assisted therapeutic ERC may be associated with an increased risk of pancreatitis. Improvement of the available equipment is necessary to perform more efficient and effective biliary interventions.
Background Percutaneous endoscopic gastrostomy (PEG) is an invasive procedure that can result in bleeding. Guidelines recommend discontinuing clopidogrel for 7 to 10 days, but not withholding ...aspirin, before PEG. Serotonin reuptake inhibitors (SRIs) have been associated with an increased risk of GI bleeding. Objective To determine whether there is an association between periprocedural aspirin, clopidogrel, or SRI use and bleeding in patients who underwent PEG tube placement. Design Retrospective cohort study. Setting Large quaternary-care academic medical center. Patients A total of 990 patients (525 men) with a median age of 69.8 years who underwent PEG from January 1999 to April 2009. Interventions PEG tube placement. Main Outcome Measurements GI bleeding. Results Sixteen patients (1.6%) had evidence of bleeding during the first 48 hours after PEG, and 12 patients (1.2%) had evidence of bleeding between 48 hours and 14 days after PEG. Thirty-six patients (3.6%) received high-dose aspirin (>325 mg), 27 patients (2.7%) received clopidogrel (75 mg), and 99 patients (10%) received an SRI before PEG. Twenty-four patients (2.4%) received high-dose aspirin, 25 patients (2.5%) received clopidogrel, and 130 patients (13.1%) received an SRI after PEG. Multivariate analysis demonstrated no association between periprocedural use of aspirin (at any dose) or clopidogrel and post-PEG bleeding. However, SRIs administered 24 hours or less before PEG were associated with a significantly higher odds of post-PEG bleeding (adjusted odds ratio 4.1; 95% CI, 1.1-13.4; P = .04). Limitations Retrospective, single-center study with limited statistical power despite a relatively large cohort of patients. Conclusions Use of aspirin or clopidogrel before or after PEG was not associated with procedure-related bleeding. SRI use in the 24 hours before PEG was associated with an increased risk of bleeding.
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