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        Factors Affecting the Learning Curve in the Endoscopic Ultrasound-Guided Sampling of Solid Pancreatic Lesions: A Prospective Study

        Razpotnik Marcel,Bota Simona,Kutilek Mathilde,Essler Gerolf,Urak Christian,Prosenz Julian,Weber-Eibel Jutta,Maieron Andreas,Peck-Radosavljevic Markus 거트앤리버 소화기연관학회협의회 2023 Gut and Liver Vol.17 No.2

        Background/Aims: Endosonography is associated with a long learning curve. We aimed to assess variables that may influence the diagnostic outcomes in endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) of solid pancreatic tumors regarding the level of endoscopists' experience. Methods: Consecutive patients undergoing EUS-guided puncture of solid pancreatic tumors (eight endosonographers, including six trainees) were prospectively enrolled. An experienced endosonographer was defined as having performed at least 250 EUS examinations, including 75 FNA/Bs. The final diagnosis was determined by cytopathology, histopathology, or clinical followup. Results: In total, 283 EUS-FNA/Bs of solid pancreatic tumors (75.6% malignant) in 239 patients (median age 69 years, 57.6% males) were enrolled. Trainees performed 149/283 (52.7%) of the interventions. Accuracy and sensitivity for detecting malignancy were significantly higher in the expert group than in the trainee group (85.8% vs 73.2%, p=0.01 and 82.5% vs 68.4%, p=0.02). Solid lesions evaluated by an expert using FNB needles showed the best odds for a correct diagnosis (odds ratio, 3.07; 95% confidence interval, 1.15 to 8.23; p=0.02). More experienced endoscopists achieved better accuracy in sampling via the transduodenal approach (86.7% vs 68.5%, p<0.001), in the sampling of malignant lesions (82.5 vs 68.4, p=0.02), and in the sampling of lesions located in the pancreatic head (86.1 vs 69.1, p=0.02). In cases involving these factors, we observed a moderate improvement in the diagnostic accuracy after 40 attempts. Conclusions: Transduodenal approach, pancreatic head lesions, and malignancy were recognized as the most important clinical factors affecting the learning curve in EUS-FNA/B of solid pancreatic lesions.

      • Ledipasvir/Sofosbuvir for 12 or 24 Weeks Is Safe and Effective in Kidney-transplant Recipients with Genotype 1 or 4 HCV Infection

        ( Massimo Colombo ),( Alessio Aghemo ),( Lin Liu ),( Robert H. Hyland ),( Chohee Yun ),( Diana M. Brainard ),( John G. Mchutchison ),( Sunjin Hwang ),( Marc Bourliere ),( Markus Peck-radosavljevic ),( 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

        Methods: Kidney transplant recipients with chronic GT1 or GT4 HCV infection, treatment-naive and treatment-experienced, with or without compensated cirrhosis were randomized 1:1 at 5 sites in Europe to receive LDV/SOF (90 mg/400 mg) for 12 or 24 weeks. Randomization was stratified by HCV genotype, treatment history and presence or absence of cirrhosis. Cirrhosis was determined by liver biopsy (Metavir score = 4 or Ishak score ≥5), Fibroscan® >12.5 kPa, or Fibrotest® >0.75 and APRI >2. A pretreatment creatinine clearance <40 mL/min was an exclusionary criterion. The primary endpoint was SVR12. Results: 114 patients were randomized and treated; median age was 53, 58% were male, 94% were white, 72% carried the non-CC IL28B allele, 91% had GT 1 infection, 69% were treatment-naive, and 15% had compensated cirrhosis. The median eGFR was 56ml/min (range 35-135ml/min). All 92 patients with SVR4 data available achieved SVR4 including a patient discontinuing treatment at Week 4 due to an AE. SAEs were reported in 12 (11%) patients; 3 were assessed as treatment related: syncope, pulmonary embolism, and blood creatinine increased. The most frequent AEs were headache (19%), asthenia (13%), and fatigue (10%). Conclusions: Administration of LDV/SOF for 12 or 24 weeks in patients with chronic HCV genotype 1 or 4 patients who have undergone kidney transplant was safe and highly effective with an SVR4 rate of 100%. Treatment was well-tolerated. SVR12 data for all patients will be presented.

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