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

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.

What is the Impact of the Proportion of Solid Necrotic Content on the Number of Necrosectomies during EUS-Guided Drainage using Lumen-Apposing Metallic Stents of Pancreatic Walled-off Necrosis ?

“…Our 86% clinical success with LAMS is comparable to the reported rates of 80-97% [12,[22][23][24]. They were better with interventional radiology support for pseudoaneurysm bleedings, although our rate of 4.34% (2/46) was below the reported range (5.1-15%) [12,[25][26][27]. The higher need for surgery (10.8%), compared to other studies [22,23], was related to bleeding and loss of LAMS apposition during DEN, although we performed DEN only when necessary (obstruction/infection), avoiding immediate DEN during the index procedure.…”

Endoscopic gastrointestinal anastomosis: a review of established techniques

“…22,25 Two other stents commonly used in EUS-GE are the Nagi stent (Taewoong Medical) and the self-approximating lumenapposing metallic stent (Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea). 27,28 Conceptually, larger-diameter stents are better. However, larger stents often have stiffer delivery systems that may push the small bowel away during insertion.…”

Endoscopic management of walled‐off pancreatic necrosis

“…As a result, the risk of stent‐related adverse events was relatively low (6.8%). The authors suggested that the properties of the LAMS might reduce the risk of stent‐related adverse events including a buried stent or stent induced bleeding 39 …”