title: A pilot proof-of-concept study of a modified device for one-step endoscopic ultrasound-guided biliary drainage in a new experimental biliary dilatation animal model.
abstract: OBJECTIVE
  To evaluate the technical feasibility of a modified tapered metal tip and low profile introducer for one-step endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) in a new experimental biliary dilatation porcine model.
  
  
  METHODS
  A novel dedicated device for one-step EUS-guided biliary drainage system (DEUS) introducer has size 3F tapered catheter with size 4F metal tip for simple puncture of the intestinal wall and liver parenchyma without graded dilation. A self-expandable metal stent, consisting of both uncovered and nitinol-covered portions, was preloaded into DEUS introducer. After establishment of a biliary dilatation model using endoscopic hemoclips or band ligation with argon plasma coagulation in 9 mini-pigs, EUS-BD using a DEUS was performed following 19-G needle puncture without the use of fistula dilation devices.
  
  
  RESULTS
  One-step EUS-BD was technically successful in seven pigs [7/9 (77.8%) as intention to treat] without the aid of devices for fistula dilation from the high body of stomach or far distal esophagus to the intrahepatic (n = 2) or common hepatic (n = 5) duct. Primary technical failure occurred in two cases that did not show adequate biliary dilatation. In seven pigs with a successful bile duct dilatation, the technical success rate was 100% (7/7 as per protocol). Median procedure time from confirmation of the dilated bile duct to successful placement of a metallic stent was 10 min (IQR; 8.9-18.1). There were no immediate procedure-related complications.
  
  
  CONCLUSIONS
  Modified tapered metal tip and low profile introducer may be technically feasible for one-step EUS-BD in experimental porcine model.
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Tae Hoon
authors.initials: TH
authors.lastname: Lee
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Jun Hyuck
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Sang Soo
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Hyun Deuk
authors.initials: HD
authors.lastname: Cho
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Dong Wan
authors.initials: DW
authors.lastname: Seo
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Sung Koo
authors.initials: SK
authors.lastname: Lee
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Myung-Hwan
authors.initials: MH
authors.lastname: Kim
authors.affiliation: Tae Hoon Lee, Sang-Heum Park, Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University School of Medicine, Cheonan Hospital, Chungcheongnam-do 330-721, South Korea.
authors.forename: Do Hyun
authors.initials: DH
authors.lastname: Park
mesh_terms: D000497:Alloys / Q000737:chemistry; D000818:Animals; D001652:Bile Ducts / Q000473:pathology; D004106:Dilatation / Q000295:instrumentation / Q000379:methods*; D004195:Disease Models, Animal; D004322:Drainage / Q000295:instrumentation / Q000379:methods*; D004724:Endoscopy / Q000379:methods*; D005260:Female; D007422:Intestines / Q000473:pathology; D008099:Liver / Q000473:pathology; D008670:Metals; D023421:Models, Animal; D010865:Pilot Projects; D015607:Stents; D013552:Swine; D013556:Swine, Miniature; D016896:Treatment Outcome; D014463:Ultrasonography / Q000379:methods*
chemical_list: D000497:Alloys; D008670:Metals; C013616:nitinol
keywords: Biliary dilation; Biliary drainage; Complications; Endoscopic ultrasound; Feasibility