Portal de Periódicos da CAPES

Feasibility and safety of a novel dedicated device for one‐step EUS‐guided biliary drainage: A randomized trial

2015; Wiley; Volume: 30; Issue: 10 Linguagem: Inglês

10.1111/jgh.13027

1440-1746

Do Hyun Park, Tae Hoon Lee, Woo Hyun Paik, Jun‐Ho Choi, Tae Jun Song, Sang Soo Lee, Dong‐Wan Seo, Sung Koo Lee, Myung‐Hwan Kim,

Pancreatic and Hepatic Oncology Research

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.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, n = 16) or a conventional 8.5F biliary metal stent introducer with a fully covered metal stent (FC group, n = 16). The technical success, procedural times, clinical success rate, and adverse event rates were evaluated.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 vs. 15 min, P = 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 vs. 6.3% [1/16] in the DH, P = 0.172), although not statistically significant.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.