title: Results of a Japanese multicenter, randomized trial of endoscopic stenting for non-resectable pancreatic head cancer (JM-test): Covered Wallstent versus DoubleLayer stent.
abstract: BACKGROUND
  No study has compared covered metallic stents with Tannenbaum stents. We evaluated the efficacy of the DoubleLayer stent (DLS) and Covered Wallstent (CWS) in patients with pancreatic head cancer (PHC).
  
  
  METHODS
  This was a multicenter, prospective randomized study. Between October 2005 and December 2007, we enrolled 113 patients (58 DLS, 55 CWS) with unresectable PHC with distal biliary obstructions and observed them for at least 6 months.
  
  
  RESULTS
  No significant difference in patient survival was found between groups, with a median survival of 231 and 248 days in the DLS and CWS groups, respectively. The cumulative stent patency was significantly higher (P = 0.0072) in the CWS group. The respective mean and median stent patency was 202 and 133 days in the DLS group and 285 and 419 days in the CWS group. The incidence of DLS occlusion (53.5%) was significantly higher than that of CWS (23.6%; P = 0.0019). The respective causes of occlusion were tumor overgrowth (0, 1), ingrowth (0, 2), sludge (24, 2), food impaction (3, 5), kinking bile duct (2, 0), and other (2, 3). Other complications were cholecystitis (0, 4), pancreatitis (0, 1), migration (1, 5), liver abscess (2, 0), and other (1, 2). No significant difference in the incidence of complications between groups was observed.
  
  
  CONCLUSIONS
  CWS had significantly longer patency than DLS for the management of PHC with obstructive jaundice. The incidence of complications other than stent occlusion was higher in CWS, but this difference did not reach significance.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. isayama-tky@umin.ac.jp
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Ichiro
authors.initials: I
authors.lastname: Yasuda
authors.forename: Shomei
authors.initials: S
authors.lastname: Ryozawa
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Maguchi
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Igarashi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Matsuyama
authors.forename: Akio
authors.initials: A
authors.lastname: Katanuma
authors.forename: Osamu
authors.initials: O
authors.lastname: Hasebe
authors.forename: Atsushi
authors.initials: A
authors.lastname: Irisawa
authors.forename: Takao
authors.initials: T
authors.lastname: Itoi
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Mukai
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Arisaka
authors.forename: Kazumu
authors.initials: K
authors.lastname: Okushima
authors.forename: Koji
authors.initials: K
authors.lastname: Uno
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Kida
authors.forename: Kiichi
authors.initials: K
authors.lastname: Tamada
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde; D005260:Female; D006801:Humans; D007564:Japan; D041781:Jaundice, Obstructive / Q000209:etiology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000150:complications* / Q000473:pathology; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome