Does prophylactic administration of corticosteroid reduce the risk and severity of post-ERCP pancreatitis: a randomized, prospective, multicenter study.
BACKGROUND
Pancreatitis is the most common major complication of diagnostic and therapeutic ERCP. There have been continuing efforts to identify a pharmacologic agent capable of reducing the frequency and severity of this complication. On the basis of several case reports, experimental data, and knowledge of their mechanism of action, corticosteroids might be effective in this regard. The aim of this randomized, double-blind, controlled trial was to determine whether prophylactic, orally administered corticosteroid reduces the frequency and/or severity of post-ERCP pancreatitis.


METHODS
A total of 1115 patients were randomized to receive either prednisone (40 mg) or a placebo orally 15 hours and 3 hours before ERCP. A 160 variable database was prospectively collected according to a defined protocol on patients undergoing diagnostic or therapeutic ERCP at 15 centers in the Midwest Pancreaticobiliary Group. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis.


RESULTS
The overall frequency of pancreatitis was 15.07%. It occurred in 92 of 555 patients in the corticosteroid group (16.6%), and in 76 of 560 patients in the control group (13.6%; p = 0.19). The pancreatitis was mild in 10.04%, moderate in 4.04%, and severe in 0.99%. There was no difference between the groups with regard to the severity of pancreatitis. Moreover, the groups were similar with regard to age, gender, body mass index, frequency of prior pancreatitis, type of procedure performed (diagnostic or therapeutic), difficulty of cannulation, frequency of pre-cut sphincterotomy, pancreatic sphincterotomy, sphincter of Oddi dysfunction, sphincter of Oddi manometry, pancreatic acinarization, chronic pancreatitis, number of pancreatic duct injections, and bile duct diameter.


CONCLUSIONS
Prophylactic orally administered corticosteroid did not reduce the frequency or severity of post-ERCP pancreatitis.
Sherman
Stuart
S
Indiana University Medical Center, Indianapolis 46202, USA.
Blaut
Urszula
U
Watkins
James L
JL
Barnett
Jeffrey
J
Freeman
Martin
M
Geenen
Joseph
J
Ryan
Michael
M
Parker
Harrison
H
Frakes
James T
JT
Fogel
Evan L
EL
Silverman
William B
WB
Dua
Kulwinder S
KS
Aliperti
Giuseppe
G
Yakshe
Paul
P
Uzer
Michael
M
Jones
Whitney
W
Goff
John
J
Earle
Dee
D
Temkit
M'hamed
M
Lehman
Glen A
GA
D000284:Administration, Oral; D000328:Adult; D017677:Age Distribution; D000368:Aged; D016009:Chi-Square Distribution; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000175:diagnosis; D010195:Pancreatitis / Q000453:epidemiology / Q000517:prevention & control*; D011241:Prednisone / Q000008:administration & dosage*; D011322:Primary Prevention / Q000379:methods*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index
D011241:Prednisone