Original Articles
Nifedipine for prevention of post-ERCP pancreatitis: A prospective, double-blind randomized study

Presented as a poster at the annual Digestive Disease Week, May 20-23, 2001, Atlanta, Georgia (Gastrointest Endosc 2001;53:AB105), and as an oral communication at the 2001 edition of the “Journées Francophones de Pathologie Digestive,” March 24-28, 2001, Paris, France.
https://doi.org/10.1016/S0016-5107(02)70178-8Get rights and content

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]). Conclusion: 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. (Gastrointest Endosc 2002;56:202-8.)

Section snippets

Patients and methods

Patients referred to our center for ERCP, with or without sphincterotomy, on an inpatient basis (hospitalized at least 24 hours) were eligible for enrollment in the study. Exclusion criteria were (1) presentation with acute pancreatitis or acute abdominal pain caused by chronic pancreatitis, (2) treatment with calcium channel inhibitors, (3) pregnancy or not using effective methods of contraception for women able to procreate, (4) mental impairment, (5) upper GI obstruction, (6) previous

Results

Of the total of 155 patients included in the study, 76 were randomized to the nifedipine group and 79 to the placebo group. One hundred twenty-nine patients (83.2%) completed the protocol and were eligible for per-protocol analysis. The remaining 26 patients (nifedipine 18, 16.8%; placebo 8, 10.1%; p = 0.02) received medication or placebo only once, either before or after ERCP, generally because blood pressure was lower than 80 mm Hg at the time scheduled for administration. Major patient

Discussion

Pancreatitis is the most frustrating complication of ERCP for two reasons: (1) Although certain risk factors have been clearly identified,1, 2, 3, 6, 7, 18 knowledge of these is not really helpful in avoiding pancreatitis in the individual patient; the development of pancreatitis remains unpredictable. This is confirmed in the present study by the finding that “difficult” ERCP was the most significant and the sole independent predictor of pancreatitis as well as persistent pain. The existence

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Reprint requests: F. Prat, MD, Service des Maladies du Foie et de l'Apareil Digestif, CHU de Bicêtre, 78, rue de Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex, France.

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