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ALLOPURINOL IN THE PREVENTION OF ERCP PANCREATITIS: PRELIMINARY RESULTS FROM A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL
J Romagnuolo, RJ Bailey, ST Mortimer, DN Todoruk, JP Ferguson, C deGara
Division of Gastroenterology and Department of General Surgery, McGill University Health Centre, Montreal, Quebec and Royal Alexandra Hospital, Edmonton, Alberta
BACKGROUND: The xanthine oxidase inhibitor, Allopurinol, by reducing oxygen free radicals, is an interesting candidate for the prevention of ERCP pancreatitis. Animal/ex-vivo models of obstructive/ischemic pancreatitis have demonstrated a reduction in hyperenzymemia and/or frank pancreatitis.
AIM: The aim of this study is to assess the efficacy of allopurinol in the prevention of ERCP pancreatitis in humans a randomized controlled trial.
METHODS: Consecutive patients referred for ERCP at a tertiary centre were recruited. Current users of allopurinol, or patients with recent acute pancreatitis were excluded. Lipase levels were measured before, and 3 and 24 hrs after, ERCP. After randomization, patients were given 300mg allopurinol or placebo PO 1 hr prior to ERCP. Potential confounders such as age, sex, indication, sphincterotomy, pancreatic duct (PD) injection, fellow involvement, procedure duration, and final diagnosis were recorded. Pancreatitis (1° outcome) was defined as pancreatic pain with a 3-fold lipase rise. Hospital visits were recorded. Telephone contact was attempted by a blinded physician at 7 d to capture missed episodes of pancreatitis. Fisher’s Exact was used to compare proportions and t-tests for continuous variables.
RESULTS: 27 patients were randomized: 13 to allopurinol, 14 to placebo. Mean ages were 57.5±20 and 53.6±16 yrs, respectively; the male proportion was 30.8% and 35.7%. Six patients (46.2%) had sphincterotomy vs 5 (35.7%), and the frequencies of PD cannulation were similar. 3hr lipase levels were significantly lower after allopurinol (552±1006 vs 2186±2898 U/L), however, 24 hr levels (1242 vs 1324 U/L) were similar. The primary outcome was less common with allopurinol (0 vs 3 (21.4%)) patients, but this trend was not significant. Only 1 case required admission (5 days).
CONCLUSIONS: These preliminary results suggest that allopurinol reduces early hyperenzymemia following ERCP. Further recruitment will determine whether post-ERCP pancreatitis is prevented by allopurinol.