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        Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole

        ( Justin C Y Wu ),( Bor-shyang Sheu ),( Ming-shiang Wu ),( Yong Chan Lee ),( Myung-gyu Choi ) 대한소화기 기능성질환·운동학회 2020 Journal of Neurogastroenterology and Motility (JNM Vol.26 No.1

        Background/Aims Since the use of dexlansoprazole in Asian subjects with gastroesophageal reflux disease (GERD) has not been adequately characterized, this study was conducted to evaluate the efficacy and safety of dexlansoprazole modified-release in Asian subjects with non-erosive reflux disease (NERD) and erosive esophagitis (EE). Methods In this phase 4, open-label, non-randomized, uncontrolled, multicenter, multi-country study sponsored by Takeda, subjects aged ≥ 20 years with persistent typical GERD symptoms for at least 6 months underwent endoscopy. Based on endoscopic findings, they were assigned to either dexlansoprazole modified-release 30 mg once-daily for 4 weeks (NERD group) or dexlansoprazole modified-release 60 mg once-daily for 8 weeks (EE group). The primary endpoint was the percentage of days that subjects did not experience any 24- hour heartburn or acid regurgitation. Results Of the 445 subjects screened from Hong Kong, South Korea, and Taiwan, 208 were enrolled in the NERD group (mean age: 53.6 years, male: 34.6%) and 88 in the EE group (mean age: 51.7 years, male: 55.7%). Over the treatment period, the median percentage of days that subjects did not experience any 24-hour heartburn or acid regurgitation was 26.9% and 65.5% in the NERD and EE groups, respectively; for nighttime heartburn or acid regurgitation the proportions were 59.3% and 83.3%, respectively. The treatment was well tolerated with low incidence of treatment-related adverse events in NERD and EE groups (6.7% and 5.7%, respectively). Conclusion In Asian patients with GERD, treatment with dexlansoprazole modified-release indicates a favorable efficacy and safety profile in relieving heartburn and acid regurgitation symptoms.

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        Confirming Whether Fine Needle Biopsy Device Shortens the Learning Curve of Endoscopic Ultrasound-Guided Tissue Acquisition Without Rapid Onsite Evaluation

        Meng-Ying Lin,Cheng-Lin Wu,Mitsuhiro Kida,Wei-Lun Chang,Bor-Shyang Sheu 대한소화기내시경학회 2021 Clinical Endoscopy Vol.54 No.3

        Background/Aims: Endoscopic ultrasonography (EUS)-guided tissue acquisition requires a long learning curve. We aimed tocompare the skill maturation curves between fine needle aspiration (FNA) and biopsy (FNB) for tissue acquisition. Methods: The initial 60 procedures performed by the trainee endosonographer (30 FNA vs. 30 FNB) were consecutively enrolled. The difference in procedure performance was compared between the two groups. Learning curves were assessed. Twenty additionalcases were subsequently enrolled to assess the consistency of performance in the FNB group. Results: The FNB group acquired larger tissue samples (2.35 vs. 0.70 mm2; p<0.001) with lower blood content (p=0.001) and highertissue quality (p=0.017) compared with the FNA group. In addition, the FNB group required less needle pass to establish a diagnosis(2.43 vs. 2.97; p=0.006). A threshold diagnostic sensitivity of ≥80% was achieved after performing 10 FNB procedures. The numberof needle passes significantly decreased after conducting 20 FNB procedures (1.80 vs. 2.70; p=0.041). The diagnostic sensitivity andnumber of needle passes remained the same in the subsequent FNB procedures. By contrast, this skill maturation phenomenon wasnot observed after performing 30 FNA procedures. Conclusions: In EUS-guided tissue acquisition, the FNB needle was more efficient and thus shortened the learning curve of EUSguidedtissue acquisition in trainee endosonographers.

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        Tissue Quality Comparison Between Heparinized Wet Suction and Dry Suction in Endoscopic Ultrasound-Fine Needle Biopsy of Solid Pancreatic Masses: A Randomized Crossover Study

        Lin Meng-Ying,Wu Cheng-Lin,Su Yung-Yeh,Huang Chien-Jui,Chang Wei-Lun,Sheu Bor-Shyang 거트앤리버 소화기연관학회협의회 2023 Gut and Liver Vol.17 No.2

        Background/Aims: A high-quality sample allows for next-generation sequencing and the administration of more tailored precision medicine treatments. We aimed to evaluate whether heparinized wet suction can obtain higher quality samples than the standard dry-suction method during endoscopic ultrasound (EUS)-guided biopsy of pancreatic masses. Methods: A prospective randomized crossover study was conducted. Patients with a solid pancreatic mass were randomly allocated to receive either heparinized wet suction first or dry suction first. For each method, two needle passes were made, followed by a switch to the other method for a total of four needle punctures. The primary outcome was the aggregated white tissue length. Histological blood contamination, diagnostic performance and adverse events were analyzed as secondary outcomes. In addition, the correlation between white tissue length and the extracted DNA amount was analyzed. Results: A total of 50 patients were enrolled, and 200 specimens were acquired (100 with heparinized wet suction and 100 with dry suction), with one minor bleeding event. The heparinized wet suction approach yielded specimens with longer aggregated white tissue length (11.07 mm vs 7.96 mm, p=0.001) and less blood contamination (p=0.008). A trend towards decreasing tissue quality was observed for the 2nd pass of the dry-suction method, leading to decreased diagnostic sensitivity and accuracy, although the accumulated diagnostic performance was comparable between the two suction methods. The amount of extracted DNA correlated positively to the white tissue length (p=0.001, Spearman̕s ρ=0.568). Conclusions: Heparinized wet suction for EUS tissue acquisition of solid pancreatic masses can yield longer, bloodless, DNA-rich tissue without increasing the incidence of adverse events (ClinicalTrials.gov. identifier NCT04707560).

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