Randomized controlled trial of pancreatic stenting to prevent pancreatitis after endoscopic retrograde cholangiopancreatography.

To determine the effectiveness of pancreatic duct (PD) stent placement for the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients.
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.
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.
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.
AuthorsYoshiaki Kawaguchi, Masami Ogawa, Fumio Omata, Hiroyuki Ito, Tooru Shimosegawa, Tetsuya Mine
JournalWorld journal of gastroenterology (World J Gastroenterol) Vol. 18 Issue 14 Pg. 1635-41 (Apr 14 2012) ISSN: 2219-2840 [Electronic] China
PMID22529693 (Publication Type: Journal Article, Randomized Controlled Trial)
  • Adult
  • Aged
  • Aged, 80 and over
  • Catheterization
  • Cholangiopancreatography, Endoscopic Retrograde (adverse effects, methods)
  • Female
  • Humans
  • Hyperamylasemia
  • Male
  • Middle Aged
  • Pancreatic Ducts (surgery)
  • Pancreatitis (etiology, prevention & control)
  • Risk Factors
  • Single-Blind Method
  • Sphincter of Oddi Dysfunction (complications)
  • Sphincterotomy, Endoscopic
  • Stents

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