1. Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy.
- Author
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Teoh AYB, Bapaye A, Lakhtakia S, Ratanachu T, Reknimitr R, Chan SM, Choi HJ, Gadhikar HP, Kongkam P, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, and Moon JH
- Subjects
- Adult, Endosonography, Female, Humans, Male, Middle Aged, Pancreatic Pseudocyst diagnostic imaging, Pancreatitis, Acute Necrotizing diagnostic imaging, Prospective Studies, Drainage instrumentation, Endoscopy instrumentation, Pancreatic Pseudocyst surgery, Pancreatitis, Acute Necrotizing surgery, Stents
- Abstract
Background: A novel self-approximating lumen-apposing metallic stent (LAMS; Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea) has recently become available. The aim of the present study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC)., Methods: This was a prospective international multicentered study conducted in six high-volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled-off pancreatic necrosis (WOPN) requiring endoscopic ultrasonography-guided drainage were recruited. Outcomes included technical and clinical success, adverse events, procedural events, interventions through the stent and recurrence rates., Results: Between August 2016 and November 2017, 59 patients were recruited to this study. Thirty-nine patients (66.1%) had WOPN and mean (SD) size of PFC was 11.5 (5.1) cm. Technical and clinical success rates were 100%. Mean (SD) procedural time was 35.0 (17.2) minutes. Sixteen-millimeter stents were used in 66.1% of the patients. Fifty-four sessions of necrosectomy were carried out with the stent in situ in 17 patients. Stent-related adverse event (AE) rate was 6.8%. Three patients (5.1%) suffered from bleeding after stenting and one required angiographic embolization. Two patients (3.4%) suffered from recurrence during a mean (SD) follow-up time of 325.6 (355.5) days. There were no differences in outcomes between those with pseudocysts or WOPN except for the duration of hospital stay (P = 0.012)., Conclusion: Use of a self-approximating LAMS for drainage of PFC was safe and effective. Endoscopic necrosectomy could be carried out through the stent with ease. The device was associated with a low rate of stent-related AE., (© 2019 Japan Gastroenterological Endoscopy Society.)
- Published
- 2020
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