Pretreatment with methylprednisolone to prevent ERCP-induced pancreatitis: a randomized, multicenter, placebo-controlled clinical trial.
OBJECTIVE
Pancreatitis remains the major complication of endoscopic retrograde cholangiopancreatography (ERCP). Uncontrolled data suggest a lower incidence of pancreatitis in patients with a history of iodine sensitivity when given pretreatment with corticosteroids. We conducted a clinical trial to assess the efficacy of a commonly prescribed corticosteroid, methylprednisolone, to prevent ERCP-induced pancreatitis.


METHODS
Patients were entered into a randomized, multicenter, double-blind, placebo-controlled study of intravenous methylprednisolone (125 mg) versus a saline placebo immediately before the ERCP. All patients were evaluated for early and late complications.


RESULTS
Two hundred eighty-six patients were randomized. Thirty-one randomized patients were excluded for technical reasons at the time of ERCP. Overall, the incidence of pancreatitis was 16 of 129 (12.4%, 95% CI: 6.7-18.1%) in the methylprednisolone group and 11 of 126 (8.7%, 95% CI: 4.4-15.1%) in the placebo group, which was not significantly different (p = 0.34). Although there was a higher rate of sphincterotomy performed in the methylprednisolone group compared to the control group (31.8% vs 16.8%, p = 0.005), the incidence of pancreatitis was not different when patients undergoing sphincterotomy were analyzed separately (13.6% in the methylprednisolone group and 9.6% in the placebo group,p = 0.50). There was no significant difference between the two groups for those with ERCP-induced pancreatitis in hospital length of stay (p = 0.22), days of parenteral analgesia (p = 0.09), or days of parenteral nutrition (p = 0.15).


CONCLUSIONS
Intravenous methylprednisolone is not beneficial in preventing ERCP-induced pancreatitis.
Dumot
J A
JA
Department of Gastroenterology, Cleveland Clinic Foundation, Ohio 44195, USA.
Conwell
D L
DL
O'Connor
J B
JB
Ferguson
D R
DR
Vargo
J J
JJ
Barnes
D S
DS
Shay
S S
SS
Sterling
M J
MJ
Horth
K S
KS
Issa
K
K
Ponsky
J L
JL
Zuccaro
G
G
D000698:Analgesia; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D010288:Parenteral Nutrition; D010919:Placebos; D009803:Sphincter of Oddi / Q000601:surgery
D000893:Anti-Inflammatory Agents; D010919:Placebos; D008775:Methylprednisolone