Browsing by Author "Shah, Raj J."

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    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 (RATES) Study
    (Elsevier, 2017) Wani, Sachin; Keswani, Rajesh; Hall, Matt; Han, Samuel; Ali, Meer Akbar; Brauer, Brian; Carlin, Linda; Chak, Amitabh; Collins, Dan; Cote, Gregory A.; Diehl, David L.; DiMaio, Christopher J.; Dries, Andrew; El-Hajj, Ihab; Ellert, Swan; Fairley, Kimberley; Faulx, Ashley; Fujii-Lau, Larissa; Gaddam, Srinivas; Gan, Seng-Ian; Gaspar, Jonathan P.; Gautamy, Chitiki; Gordon, Stuart; Harris, Cynthia; Hyder, Sarah; Jones, Ross; Kim, Stephen; Komanduri, Srinadh; Law, Ryan; Lee, Linda; Mounzer, Rawad; Mullady, Daniel; Muthusamy, V. Raman; Olyaee, Mojtaba; Pfau, Patrick; Saligram, Shreyas; Piraka, Cyrus; Rastogi, Amit; Rosenkranz, Laura; Rzouq, Fadi; Saxena, Aditi; Shah, Raj J.; Simon, Violette C.; Small, Aaron; Sreenarasimhaiah, Jayaprakash; Walker, Andrew; Wang, Andrew Y.; Watson, Rabindra R.; Wilson, Robert H.; Yachimski, Patrick; Yang, Dennis; Edmundowicz, Steven; Early, Dayna S.; Department of Medicine, IU School of Medicine
    Background and aims Based on 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) 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 using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done using a 4-point scoring system and a comprehensive data collection and reporting system was built to create learning curves 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). Overall, 3786 exams were graded (EUS:1137; ERCP–biliary 2280, pancreatic 369). Learning curves for individual endpoints, 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.
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    Role of per-oral pancreatoscopy in the evaluation of suspected pancreatic duct neoplasia: a 13-year U.S. singlecenter experience
    (Elsevier, 2017) El Hajj, Ihab I.; Brauer, Brian C.; Wani, Sachin; Fukami, Norio; Attwell, Augustin R.; Shah, Raj J.; Department of Medicine, School of Medicine
    Background and Aims The role of per-oral pancreatoscopy (POP) in the evaluation of occult pancreatic duct (PD) lesions remains limited to case series. The aim of this study was to evaluate the ability of POP to differentiate malignant from benign diseases of the PD. Methods Patients who underwent POP between 2000 and 2013 for the evaluation of indeterminate PD strictures, dilatations, or with suspected or known main duct intraductal papillary mucinous neoplasm were identified. Main outcome measurements were visual impression accuracy, POP tissue sampling, efficacy, and safety of POP. Results During the study period, 79 patients who underwent POP for the evaluation of pancreatic stricture or dilatation were identified. Technical success was achieved in 78 (97%). In the PD neoplasia group (n = 33), the final diagnosis was based on index confirmatory POP-guided tissue sampling in 29 (88%). For the detection of PD neoplasia, POP visual impression had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 87%, 86%, 83%, 91%, and 87%, respectively. When combined with POP-guided tissue sampling, the values were 91%, 95%, 94%, 93%, and 94%, respectively. Of 102 POPs performed, adverse events were noted in 12 (12%) cases. Conclusions This study demonstrates a high technical success rate, visual impression accuracy, and tissue sampling capability of POP. Examinations were performed by endoscopists with expertise in pancreatoscopy interpretation, and the results may not be generalizable.
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    Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial
    (Elsevier, 2023) Sherman, Stuart; Kozarek, Richard A.; Costamagna, Guido; Reddy, Nageshwar; Tarnasky, Paul; Shah, Raj J.; Slivka, Adam; Fogel, Evan; Watkins, James; Delhaye, Myriam; Irani, Shayan S.; Tringali, Andrea; Lakhtakia, Sundeep; Kedia, Prashant; Edmundowicz, Steven; Peetermans, Joyce A.; Rousseau, Matthew J.; Devière, Jacques; Pancreatic SEMS in Chronic Pancreatitis Study Group; Medicine, School of Medicine
    Background and aims: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. Methods: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection.