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

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Abstract
Background A novel self‐approximating lumen apposing metallic stent (LAMS) (Niti‐S Spaxus, Taewoong Medical, Korea) has recently become available. The aim of this study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC). Methods This was a prospective international multi‐centered study conducted in 6 high volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled‐off pancreatic necrosis (WOPN) requiring EUS‐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 the study. 39 patients (66.1%) had WOPN and the mean (S.D.) size of the PFC's were 11.5 (5.1) cm. The technical and clinical success rates were 100%. The mean (S.D.) procedural time was 35.0 (17.2) minutes. The 16mm stents were used in 66.1% of the patients. 54 sessions of necrosectomy were performed with the sent in situ in 17 patients. Stent‐related adverse events (AE) was 6.8%. 3 patients (5%) suffered from bleeding after stenting and 1 required angiographic embolization. Two patients (3.3%) suffered from recurrence during a mean (S.D.) 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 The use of a self‐approximating LAMS for drainage of PFC's was safe and effective. Endoscopic necrosectomy could be performed through the stent with ease. The device was associated with a low rate of stent‐related AE's.

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