title: Nifedipine for prevention of post-ERCP pancreatitis: a prospective, double-blind randomized study.
abstract: BACKGROUND
  Pancreatitis is the most common complication of ERCP. Calcium channel inhibitors have been shown to prevent the development of experimental pancreatitis. The aim of this randomized, placebo-controlled trial was to determine whether the calcium channel blocker nifedipine prevents post-ERCP pancreatitis.
  
  
  METHODS
  Patients referred for ERCP were enrolled. Those being treated with a calcium channel inhibitor and those with acute or chronic pancreatitis were excluded. Nifedipine or placebo was administered orally less than 3 hours before and within 6 hours after ERCP. The main outcome measure was the number of cases of post-ERCP pancreatitis; a secondary outcome was the rate of post-ERCP pain (without pancreatitis) that persisted for 12 or more hours.
  
  
  RESULTS
  One hundred fifty-five patients (70 women, 85 men; mean [SD] age 65.8 [18.2] years; range, 23-97 years) were enrolled and randomized to receive nifedipine (76 patients) or placebo (79 patients). The two groups were comparable. Procedures performed were retrograde diagnostic cholangiopancreatography alone (n = 33), biliary sphincterotomy (n = 31), stone extraction (n = 39), stent placement (n = 37), sphincteroplasty (n = 5), and other (n = 3). ERCP was unsuccessful in 5 patients. A single case of severe pancreatitis was observed (placebo group). The rate of post-ERCP pancreatitis was not different between groups (nifedipine, 10 patients, 13.2%; placebo, 14 patients, 17.7%; p = 0.4). The frequency of post-ERCP pain was not different between the groups. The only independent predictor of post-ERCP pancreatitis was difficult cannulation in both groups (OR = 3.78: 95% CI [1.25, 11.45]).
  
  
  CONCLUSIONS
  This study failed to demonstrate a significant effect of nifedipine in the prevention of post-ERCP pancreatitis. A multicenter trial with greater statistical power would be needed to demonstrate a benefit for this drug.
authors.affiliation: Service des Maladies du Foie et de l'Appareil Digestif, CHU de Bicêtre, Le Kremlin-Bicêtre, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Prat
authors.forename: Juan
authors.initials: J
authors.lastname: Amaris
authors.forename: Béatrice
authors.initials: B
authors.lastname: Ducot
authors.forename: Muriel
authors.initials: M
authors.lastname: Bocquentin
authors.forename: Jacques
authors.initials: J
authors.lastname: Fritsch
authors.forename: André Daniel
authors.initials: AD
authors.lastname: Choury
authors.forename: Gilles
authors.initials: G
authors.lastname: Pelletier
authors.forename: Catherine
authors.initials: C
authors.lastname: Buffet
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000517:prevention & control; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D016717:Sphincterotomy, Endoscopic
chemical_list: D002121:Calcium Channel Blockers; D009543:Nifedipine