Feasibility and safety of a novel dedicated device for one‐step EUS‐guided biliary drainage: A randomized trial. Issue 10 (October 2015)

• Record Type: Journal Article
• Authors: Park, Do Hyun; Lee, Tae Hoon; Paik, Woo Hyun; Choi, Jun‐Ho; Song, Tae Jun; Lee, Sang Soo; Seo, Dong‐Wan; Lee, Sung Koo; Kim, Myung‐Hwan
• Is Part Of: Journal of gastroenterology and hepatology. Volume 30:Issue 10(2015:Oct.)
• Page Start: 1461
• Page End: 1466
• Publication Date: 2015-10
• Subjects: Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Liver Diseases -- Periodicals; 616.33
• DOI: 10.1111/jgh.13027
• Languages: English
• ISSNs: 0815-9319

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="jgh13027-sec-0001" sec-type="section"> <title>Background and Aims</title> <p>EUS‐guided biliary drainage (EUS‐BD) has been proposed as an alternative for patients after failed ERCP. To date, the evaluation of dedicated device for one‐step EUS‐BD has been limited. To determine feasibility and safety of a newly designed 7F stent introducer with tapered metal tip as a push‐type dilator for one‐step metal stent placement without additional fistula dilation in EUS‐BD.</p> </sec> <sec id="jgh13027-sec-0002" sec-type="section"> <title>Methods</title> <p>Thirty‐two patients with malignant biliary obstruction and failed ERCP were randomly assigned to a dedicated stent introducer with a modified hybrid metal stent (DH group, <italic>n</italic> = 16) or a conventional 8.5F biliary metal stent introducer with a fully covered metal stent (FC group, <italic>n</italic> = 16). The technical success, procedural times, clinical success rate, and adverse event rates were evaluated.</p> </sec> <sec id="jgh13027-sec-0003" sec-type="section"> <title>Results</title> <p>One‐step technical success without additional fistula dilation in the DH was 88% (14/16). Multi‐step process in a stent placement was performed in all patients of the FC group. The procedural time in the DH was significantly shorter than the FC (10 <italic>vs.</italic> 15 min, <italic>P</italic> = 0.007). No difference in overall technical or clinical success was seen between the groups. The rate of an early adverse event was common in the FC compared with the DH (31.3% [5/16] in the FC <italic>vs.</italic> 6.3% [1/16] in the DH, <italic>P</italic> = 0.172), although not statistically significant.</p> </sec> <sec id="jgh13027-sec-0004" sec-type="section"> <title>Conclusions</title> <p>A dedicated device for one‐step EUS‐BD may be technically feasible, safe, and shorten the procedural times with less chance of an additional fistula dilation process, resulting in a potential reduction of the early adverse events.</p> </sec> </abstract>