Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial.
OBJECTIVE
Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP.


METHODS
A randomized, double-blind, placebo-controlled multicenter study including patients from 14 European centers was performed. A total of 820 patients were entered; 806 were randomized.


METHODS
The active drug was transdermal GN (Discotrine/Minitran, 3M Pharma) 15 mg/24 hours; placebo (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL.


RESULTS
Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared with the PL group was not statistically significant (P = .11). Thirteen had mild pancreatitis (4 in the GN group, 9 in the PL group), 26 had moderate pancreatitis (9 in the GN group, 17 in the PL group), and 8 had severe pancreatitis (5 in the GN group, 3 in the PL group). Headache (P < .001) and hypotension (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure.


CONCLUSIONS
The trial showed no statistically significant preventive effect of GN on PEP. Because of a considerable risk of a type II error, an effect of GN may have been overlooked. (ClinicalTrials.gov ID: NCT00121901.).
Nøjgaard
Camilla
C
Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.
Hornum
Mads
M
Elkjaer
Margarita
M
Hjalmarsson
Claes
C
Heyries
Laurent
L
Hauge
Truls
T
Bakkevold
Kåre
K
Andersen
Per Kragh
PK
Matzen
Peter
P
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000009:adverse effects; D019283:Pancreatitis, Acute Necrotizing / Q000209:etiology / Q000517:prevention & control*; D012306:Risk; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D014665:Vasodilator Agents; D005996:Nitroglycerin