title: Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography.
abstract: OBJECTIVE
  To determine the effectiveness of pancreatic duct (PD) stent placement for the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients.
  
  
  METHODS
  Authors conducted a single-blind, randomized controlled trial to evaluate the effectiveness of a pancreatic spontaneous dislodgement stent against post-ERCP pancreatitis, including rates of spontaneous dislodgement and complications. Authors defined high risk patients as having any of the following: sphincter of Oddi dysfunction, difficult cannulation, prior history of post-ERCP pancreatitis, pre-cut sphincterotomy, pancreatic ductal biopsy, pancreatic sphincterotomy, intraductal ultrasonography, or a procedure time of more than 30 min. Patients were randomized to a stent group (n = 60) or to a non-stent group (n = 60). An abdominal radiograph was obtained daily to assess spontaneous stent dislodgement. Post-ERCP pancreatitis was diagnosed according to consensus criteria.
  
  
  RESULTS
  The mean age (± standard deviation) was 67.4 ± 13.8 years and the male: female ratio was 68:52. In the stent group, the mean age was 66 ± 13 years and the male: female ratio was 33:27, and in the non-stent group, the mean age was 68 ± 14 years and the male: female ratio was 35:25. There were no significant differences between groups with respect to age, gender, final diagnosis, or type of endoscopic intervention. The frequency of post-ERCP pancreatitis in PD stent and non-stent groups was 1.7% (1/60) and 13.3% (8/60), respectively. The severity of pancreatitis was mild in all cases. The frequency of post-ERCP pancreatitis in the stent group was significantly lower than in the non-stent group (P = 0.032, Fisher's exact test). The rate of hyperamylasemia were 30% (18/60) and 38.3% (23 of 60) in the stent and non-stent groups, respectively (P = 0.05, χ(2) test). The placement of a PD stent was successful in all 60 patients. The rate of spontaneous dislodgement by the third day was 96.7% (58/60), and the median (range) time to dislodgement was 2.1 (2-3) d. The rates of stent migration, hemorrhage, perforation, infection (cholangitis or cholecystitis) or other complications were 0% (0/60), 0% (0/60), 0% (0/60), 0% (0/60), 0% (0/60), respectively, in the stent group. Univariate analysis revealed no significant differences in high risk factors between the two groups. The pancreatic spontaneous dislodgement stent safely prevented post-ERCP pancreatitis in high risk patients.
  
  
  CONCLUSIONS
  Pancreatic stent placement is a safe and effective technique to prevent post-ERCP pancreatitis. Therefore authors recommend pancreatic stent placement after ERCP in high risk patients.
authors.affiliation: Division of Gastroenterology, Tokai University School of Medicine, Isehara 259-1193, Japan. y711kawa@is.icc.u-tokai.ac.jp
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Kawaguchi
authors.forename: Masami
authors.initials: M
authors.lastname: Ogawa
authors.forename: Fumio
authors.initials: F
authors.lastname: Omata
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ito
authors.forename: Tooru
authors.initials: T
authors.lastname: Shimosegawa
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D006801:Humans; D034321:Hyperamylasemia; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts / Q000601:surgery*; D010195:Pancreatitis / Q000209:etiology* / Q000517:prevention & control*; D012307:Risk Factors; D016037:Single-Blind Method; D046628:Sphincter of Oddi Dysfunction / Q000150:complications; D016717:Sphincterotomy, Endoscopic; D015607:Stents