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.

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.).

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.

Endoscopic ultrasound-guided fine needle aspiration improves the pre-operative diagnostic yield of solid-pseudopapillary neoplasm of the pancreas: an international multicenter case series (with video).

BACKGROUND/OBJECTIVES: Solid-pseudopapillary neoplasms (SPNs) are rare pancreatic tumors, which occur most frequently in young women and are associated with an excellent prognosis. Computed tomography (CT) is used most commonly to identify these lesions, but there are few studies evaluating the role of endoscopic ultrasound (EUS) and fine needle aspiration (EUS-FNA) in the assessment of SPN. The aim of the study was to determine the incremental diagnostic yield of EUS-FNA compared with CT or EUS in the evaluation of patients with SPN. METHODS: A retrospective chart review of consecutive patients diagnosed with SPN who underwent CT, EUS, and EUS-FNA at five centers from three countries from 1998 to 2013. Patient demographics, imaging, endoscopic studies, cytopathology, and histology were reviewed. RESULTS: Thirty-four patients were identified with SPN. There were 31 (91.2 %) females, with a mean age at diagnosis of 37 years (range 16-81). The most common presenting symptom was abdominal pain which was present in 59 %. SPNs were incidentally detected in 14 (41.2 %) of the patients. The median tumor size was 4.2 cm (range 1.9-9.4). No patient had evidence of local or distant metastases. The most common appearance on EUS was of a mixed solid-cystic lesion (67.6 %). The diagnostic yield of CT and EUS alone was 23.5 and 41.2 %, respectively. CT and EUS combined had a diagnostic yield of 52.9 %. The addition of EUS-FNA significantly increased the diagnostic yield to 82.4 % compared with either CT or CT and EUS (p < 0.005). There were no reported adverse events reported. CONCLUSIONS: SPNs are rare pancreatic tumors primarily affecting young women. The addition of EUS-FNA significantly increased the pre-operative diagnostic yield of SPN to 82.4 %.

A Single-Center Experience with Minimally Invasive Transgastric ERCP in Patients with Previous Gastric Bypass: Lessons Learned and Technical Considerations.

As bariatric surgery increases, there is a growing population of patients with biliary obstruction and anatomy which precludes transoral access through endoscopic retrograde cholangiopancreatography (ERCP). Minimally invasive transgastric ERCP (TG-ERCP) offers a feasible alternative for the treatment. A retrospective review was performed of all patients who underwent laparoscopic or robotic-assisted TG-ERCP between 2010 and 2017. Chart abstraction collected demographics, procedural details, success rate, and postoperative outcomes. Forty patients were identified, of which 38 cases were performed laparoscopically and two robotically. Median operative time was 163 minutes, with an estimated blood loss of 50 cc. TG-ERCP was performed successfully in 36 cases (90%); sphincterotomy was completed in 35 patients (97%). Sixty per cent already had a cholecystectomy; in the remaining patients, it was performed concurrently. Major complications included stomach perforation (n = 1), pancreatitis (n = 3), and anemia requiring transfusion (n = 2). In patients with biliary obstruction and anatomy not suitable for ERCP, TG-ERCP can be performed in a minimally invasive fashion, with a high rate of technical success and low morbidity. We describe a stepwise, reproducible technique because it is an essential tool for the shared armamentarium of endoscopists and surgeons.

Multi-organ iron overload in an African-American man with ALAS2 R452S and SLC40A1 R561G.

BACKGROUND: X-linked sideroblastic anemia (XLSA) is associated with iron overload and mutations in ALAS2, which encodes 5-aminolevulinate synthase. There are few reports of XLSA in persons of sub-Saharan African descent. METHODS: A 47-year-old African-American man had microcytic anemia, elevated iron measures, cardiomyopathy, hepatic cirrhosis, diabetes mellitus, a history of cocaine use and hepatitis C. We amplified and directly sequenced his genomic DNA to detect mutations of SLC40A1, HFE, TFR2, HAMP, HJV and ALAS2. RESULTS: The subject's transferrin saturation was 100% and his serum ferritin was 2,960 ng/ml. An MRI scan revealed diffusely decreased T(2) signals of the heart, liver and pancreas. Transjugular right endomyocardial and liver biopsy specimens revealed marked iron deposition in cardiac myocytes and hepatocytes, and cirrhosis. He died of progressive cardiomyopathy. He was hemizygous for ALAS2 R452S (exon 9; c.1354C-->A) and heterozygous for SLC40A1 R561G (exon 8; c.1681A-->G). He did not have coding region mutations in HFE, TFR2, HAMP or HJV. CONCLUSIONS: ALAS2 R452S largely explains this patient's microcytic anemia and multi-organ iron overload and dysfunction. SLC40A1 R561G may have increased his iron absorption and overload further. Acquired factors, especially cocaine use and hepatitis C, may have contributed to his clinical phenotype.

Thrombus characterization with intravascular ultrasound: potential to predict successful thrombolysis.

PURPOSE: To define analysis methods using radiofrequency (RF) data from intravascular ultrasound (IVUS) to characterize thrombus so that the success or failure of thrombolysis can be predicted. METHODS: Experimentation was done in 2 phases: first, 40 clots created from platelet-rich (n=20) and platelet-poor (n=20) plasma were imaged with 20 and 30-MHz IVUS probes. The digitized RF signals were analyzed to determine the attenuation and slope of attenuation characteristics as a reference standard for the second part of the study. In this phase, 20 perfusion trials were performed with 10 platelet-rich and 10 platelet-poor samples in an in vitro arterial perfusion model; the composition of the samples was blinded during interrogation with IVUS. Alteplase (0.1 mg) was then infused directly into the thrombus for 1 hour; restoration of flow and amount of lysis were quantified. RESULTS: Significant differences were detected for the integrated attenuation value (p<0.001) between platelet-poor and platelet-rich clots interrogated with a 30-MHz probe, but no differences were noted using the 20-MHz catheter. However, both transducers were capable of differentiating platelet-rich and platelet-poor clots using a slope of attenuation analysis, which was successful in identifying all 20 (100%) of the blinded clots in the in vitro model. The speed and completeness of lysis were significantly higher (p<0.05) for platelet-rich (78%) than platelet-poor (21%) clots. CONCLUSIONS: IVUS preprocessed imaging is capable of differentiating various types of thrombus. This information can be used to predict the success or failure of pharmacological lysis techniques.