title: Feasibility and safety of a novel dedicated device for one-step EUS-guided biliary drainage: A randomized trial.
abstract: 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.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Do Hyun
authors.initials: DH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea.
authors.forename: Tae Hoon
authors.initials: TH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Ilsan, Republic of Korea.
authors.forename: Woo Hyun
authors.initials: WH
authors.lastname: Paik
authors.affiliation: Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea.
authors.forename: Jun-Ho
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Tae Jun
authors.initials: TJ
authors.lastname: Song
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Sang Soo
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Seo
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Sung Koo
authors.initials: SK
authors.lastname: Lee
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Myung-Hwan
authors.initials: MH
authors.lastname: Kim
mesh_terms: D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000601:surgery*; D004322:Drainage / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D019160:Endosonography / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D061646:Operative Time; D015607:Stents; D025321:Surgery, Computer-Assisted / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: biliary: neoplasms; endoscopic ultrasound; endoscopy: pancreato-biliary [ERCP]; gastroenterology