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Browsing by Author "Larghi, Alberto"
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Item Design and validation of a therapeutic EUS training program using a live animal model: Taking training to the next level(Wolters Kluwer, 2022) Sosa-Valencia, Leonardo; Huppertz, Jerôme; Wanert, Fanélie; Haberzetser, Francois; Swanström, Lee; Mangiavillano, Benedetto; Eisendrath, Pierre; Deprez, Pierre; Robles-Medranda, Carlos; Carrara, Silvia; Al-Haddad, Mohammad A.; Vilmann, Peter; Koch, Stephane; Larghi, Alberto; Khashab, Mouen; Medicine, School of MedicineBackground and objectives: EUS has evolved into a therapeutic modality for gastrointestinal disorders. Simulators, ex vivo models, and phantoms are the current teaching methods for therapeutic EUS (TEUS). We create and evaluate a high-fidelity simulated live animal model (HiFi SAM) for teaching endoscopists TEUS. Materials and methods: Designing a curriculum that uses HiFi SAM and enables trainees to perform realistic procedures with expert mentors. Results: Twenty-seven trainees participated in a 3-day program with 6 h of theoretical and 14 h of hands using life HiFi SAM. Eighteen experts participated. Twenty-two (20-25) TEUS were defined for each HiFi SAM, and 616 were performed in all. Of 616/264 (43%) were evaluated with a mean of 88 per course (ranging between 80 and 95). Ninety-one percent (240/264) of the procedures were completed successfully. In 24, success was not achieved due to technical and/or model problems. Student rating of HiFi SAM was: 71% excellent rating (scale 8-10) and 95% excellent/good. The HiFi SAM procedure evaluation was (scale 1-5): fine-needle biopsy: 4.79, radiofrequency: 4.76, common bile duct and gallbladder drainage: 4.75, cystic drainages: 4.72, neurolysis: 4.55, microbiopsy: 4.50, and hepatogastric drainage: 4.04, with an overall satisfaction rate of 4.56 (91%). A short survey showed: 83% would recommend absolutely (17% most likely), 33% think that ITEC training was sufficient for their practice, and 66% would like additional training, especially more practice in specific techniques rather than more clinical case discussion. Regarding impact on their practice, 66% of the trainees started a new procedure and/or noted improvement in previous ones. Conclusion: HiFi SAM is a complex model; however, experts and trainees are satisfied with the training this new curriculum provided.Item Low diagnostic yield of transduodenal endoscopic ultrasound-guided fine needle biopsy using the 19-gauge Flex needle: A large multicenter prospective study(Medknow Publications, 2017) Attili, Fabia; Fabbri, Carlo; Yasuda, Ichiro; Fuccio, Lorenzo; Palazzo, Laurent; Tarantino, Ilaria; Dewitt, John; Frazzoni, Leonardo; Rimbaş, Mihai; Larghi, Alberto; Medicine, School of MedicineBackground and Objectives: Previous limited experiences have reported the 19-gauge flexible needle to be highly effective in performing endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for transduodenal lesions. We designed a large multicenter prospective study with the aim at evaluating the performance of this newly developed needle. Patients and Methods: Consecutive patients with solid lesions who needed to undergo EUS sampling from the duodenum were enrolled in 6 tertiary care referral centers. Puncture of the lesion was performed with the 19-gauge flexible needle (Expect™ and Slimline Expect™ 19 Flex). The feasibility, procurement yield, and diagnostic accuracy were evaluated. Results: Totally, 246 patients (144 males, mean age 65.1 ± 12.7 years) with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were enrolled, with a mean size of 32.6 ± 12.2 mm. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%. Two centers had suboptimal procurement yields (66.7% and 64.2%). Major complications occurred in six cases: two of bleeding, two of mild acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma. Considering malignant versus nonmalignant disease, the sensitivity, specificity, positive/negative likelihood ratios, and diagnostic accuracy were 70.7% (95% confidence interval [CI]: 64.3–76.6), 100% (95% CI: 79.6–100), 35.3 (95% CI: 2.3–549.8)/0.3 (95% CI: 0.2–0.4), and 73.6% (95% CI: 67.6–79). On multivariate analysis, the only determinant of successful EUS-FNB was the center in which the procedure was performed. Conclusions: Our results suggest that the use of the 19-gauge flexible needle cannot be widely advocated and its implementation should receive local validation after careful evaluation of both the technical success rates and diagnostic yield.