title: Prospective clinical study of EUS-guided choledochoduodenostomy for malignant lower biliary tract obstruction.
abstract: OBJECTIVE
  Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) has recently been reported as an alternative to percutaneous transhepatic biliary drainage (PTBD) in cases of biliary obstruction, when endoscopic biliary drainage (EBD) is unsuccessful. However, prospective studies of EUS-CDS have not yet been performed. We conducted a prospective study to evaluate the safety, feasibility, and efficacy of EUS-CDS in patients with malignant lower biliary tract obstruction.
  
  
  METHODS
  A prospective study to confirm the safety of EUS-CDS was carried out in 6 patients, followed by a trial to evaluate the feasibility and efficacy of EUS-CDS in 12 additional patients. We placed a plastic stent from the duodenal bulb into the extrahepatic bile duct under EUS guidance using an oblique viewing echoendoscope, needle knife, guidewire, and biliary dilators.
  
  
  RESULTS
  The site of extrahepatic bile duct puncture was the common hepatic duct in 15 patients and the common bile duct in 3 patients. Mean diameter of the punctured extrahepatic bile ducts was 10 mm (range: 6-20 mm). Technical and functional success rates were 94% (17/18) and 100% (17/17), respectively. Median procedure time was 30 min (range: 10-52 min). Median duration to first oral intake after the procedure was 1 day (range: 1-3 days). Early complications were encountered in three (17%) patients, including focal peritonitis in two patients and hemobilia in one patient. During the follow-up period (median: 163 days; range: 46-484 days), 12 stent occlusion events were observed in nine patients. Re-intervention with exchange of the occluded stent was successful in 8 of 12 (66%) times. Severe early and late complications were not encountered in any patients in this study. Median duration of stent patency by Kaplan-Meier analysis was 272 days.
  
  
  CONCLUSIONS
  EUS-CDS is safe, feasible, and effective as an alternative to PTBD and EBD in cases of malignant distal biliary tract obstruction. Prospective randomized studies are needed to compare the safety and efficacy of various kinds of endoscopic devices used in EUS-CDS and to compare EUS-CDS with PTBD or EBD.
authors: Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan. khara@aichi-cc.jp
authors: Kazuo
authors: K
authors: Hara
authors: Kenji
authors: K
authors: Yamao
authors: Yasumasa
authors: Y
authors: Niwa
authors: Akira
authors: A
authors: Sawaki
authors: Nobumasa
authors: N
authors: Mizuno
authors: Susumu
authors: S
authors: Hijioka
authors: Masahiro
authors: M
authors: Tajika
authors: Hiroki
authors: H
authors: Kawai
authors: Shinya
authors: S
authors: Kondo
authors: Yuji
authors: Y
authors: Kobayashi
authors: Kazuya
authors: K
authors: Matumoto
authors: Vikram
authors: V
authors: Bhatia
authors: Yasuhiro
authors: Y
authors: Shimizu
authors: Akihiro
authors: A
authors: Ito
authors: Yoshiki
authors: Y
authors: Hirooka
authors: Hidemi
authors: H
authors: Goto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002768:Choledochostomy / Q000379:methods*; D001651:Cholestasis, Extrahepatic / Q000209:etiology / Q000601:surgery*; D003137:Common Bile Duct Diseases / Q000601:surgery*; D004322:Drainage; D016145:Endoscopy, Digestive System / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005706:Gallbladder Neoplasms / Q000150:complications; D006500:Hepatic Duct, Common / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014594:Uterine Neoplasms / Q000150:complications