J. Sand et I. Nordback, PROSPECTIVE RANDOMIZED TRIAL OF THE EFFECT OF NIFEDIPINE ON PANCREATIC IRRITATION AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, Digestion, 54(2), 1993, pp. 105-111
Endoscopic retrograde cholangiopancreatography (ERCP) is complicated b
y acute pancreatitis in up to 12% of the examinations. One possible me
chanism for this complication is the cannulation-induced sphincter of
Oddi spasm with temporary pancreatic duct obstruction. Nifedipine is k
nown to relax the sphincter of Oddi, thus possible inhibiting or reduc
ing post-ERCP +/- endoscopic sphincterotomy (EST) pancreatic irritatio
n. To test this hypothesis 166 adult patients undergoing ERCP +/- EST
were randomized to receive nifedipine (n = 82) 20 mg 3 times at 8-hour
intervals during the day of ERCP +/- EST or placebo (n = 84) in a dou
ble-blind manner. Clinical pancreatitis developed in 6 patients (4%),
in 3 patients in each group. Necrotizing pancreatitis developed in 3 p
atients, (2%) in the nifedipine group and 1 (1%) in the placebo group.
Overall 60 patients (36%) needed medication for post-ERCP +/- EST epi
gastric pain, 27 (33%) in the nifedipine group and 33 (39%) in the pla
cebo group. Of the 87 patients, who did not need any pain medication b
efore ERCP +/- EST. 34 (39%) needed pain medication after ERCP +/- EST
, 14/47 (30%) in the nifedipine group and 20/40 (50%) in the placebo g
roup (p = 0.044). Serum total amylase activity (median) increased from
189 U/l (range 39-11,950 U/l) before ERCP +/- EST to 299 U/l (range 4
3-11,824 U/l) at 12 h (p < 0.001) and 247 U/l (range 34-15,950 U/l) at
24 h (p < 0.001), with no differences between the two groups. Median
serum C-reactive protein concentration and blood leukocyte count remai
ned unchanged in both groups. We concluded that nifedipine may reduce
the epigastric pain induced by ERCP +/- EST, but does not seem to prev
ent post-ERCP +/- EST acute pancreatitis.