title: Prophylactic 5-Fr pancreatic duct stents are superior to 3-Fr stents: a randomized controlled trial.
abstract: BACKGROUND
  Temporary prophylactic pancreatic duct stenting effectively reduces post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients, but the optimal stent remains unclear. We compared rate of spontaneous passage, and technical difficulty of placement for 3-Fr and 5-Fr stents.
  
  
  METHODS
  A randomized controlled trial at a single academic medical center. Patients deemed high risk for PEP randomly received 5-Fr or 3-Fr pancreatic duct stents. Primary outcome was spontaneous stent passage by 2 weeks. Secondary outcomes were ease and time for stent placement, and number of guide wires required for the entire procedure.
  
  
  RESULTS
  Patients (69 female [89 %]; mean age 44.9 years, standard deviation [SD] 16.8) were randomly assigned to receive 5-Fr (n = 38) and 3-Fr (n = 40) stents. Indications for stenting were similar. Seven patients in the 3-Fr group actually received a 5-Fr stent, and two in the 5-Fr group had a 3-Fr stent. Spontaneous passage or non-passage was confirmed in 64 (83 %). No statistically significant difference in spontaneous passage rates was seen (5-Fr group, 68.4 %; 3-Fr group 75.0 %; P = 0.617). Non-passage rates were 10.5 % (5-Fr group) and 10.0 % (3-Fr group) ( P = 1.00). The study was stopped after a futility analysis for the primary end point. Placement of 5-Fr stents was rated easier, at a mean score of 1.8 (5-Fr) vs. 3.4 (3-Fr), P < 0.001, with a trend towards being faster, 9.2 vs. 11.1 minutes ( P = 0.355). Fewer guide wires were required for 5-Fr stent placement, 1.5 vs. 1.9 ( P = 0.002). PEP rates did not differ ( P = 0.519).
  
  
  CONCLUSIONS
  Placement of 5-Fr compared to 3-Fr pancreatic duct stents for PEP prophylaxis is easier, faster, and requires fewer wires. No statistically significant difference in spontaneous passage was found between the two sizes.
authors: University of Michigan Medical Center, Ann Arbor, Michigan, USA. ezolotar@med.umich.edu
authors: E
authors: E
authors: Zolotarevsky
authors: S M
authors: SM
authors: Fehmi
authors: M A
authors: MA
authors: Anderson
authors: P S
authors: PS
authors: Schoenfeld
authors: B J
authors: BJ
authors: Elmunzer
authors: R S
authors: RS
authors: Kwon
authors: C R
authors: CR
authors: Piraka
authors: E-J
authors: EJ
authors: Wamsteker
authors: J M
authors: JM
authors: Scheiman
authors: S J
authors: SJ
authors: Korsnes
authors: D P
authors: DP
authors: Normolle
authors: H Myra
authors: HM
authors: Kim
authors: G H
authors: GH
authors: Elta
mesh_terms: D000328:Adult; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts / Q000601:surgery*; D010195:Pancreatitis / Q000209:etiology* / Q000517:prevention & control*; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects