Background: Pharmacological prophylaxis of post-ERCP pancreatitis is costly
and not useful in most non-selected patients, in whom the incidence of pan
creatitis is 5% or less. However, it could be useful and probably cost-effe
ctive, in patients at high risk: for this complication, where the post-proc
edure pancreatitis rate is 10% and more.
Aim: To assess the efficacy of octreotide in reducing the incidence and sev
erity of post-ERCP pancreatitis and procedure-related hospital stay, in sub
jects with known patient-related risk factors.
Methods: A total of 120 patients were randomly allocated to receive octreot
ide or not, in a multicentre, randomized, controlled trial. The drug was gi
ven subcutaneously, 200 mug t.d.s., starting 24 h before the ERCP procedure
, in patients with either sphincter of Oddi dysfunction, or a history of re
lapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 y
ears, or who had a small common bile duct diameter (< 8 mm).
Results: A total of 114 patients (58 in the octreotide group and 56 in the
control group) completed the trial. Post-procedure pancreatitis occurred in
seven octreotide-treated patients (12.0%) and eight controls (14.3%). The
two groups showed no significant differences in the incidence or severity o
f pancreatitis. Twenty-four hours after the procedure, severe hyperamylasem
ia (more than five times the upper normal limit) without pancreatic-like pa
in was recorded in three octreotide-treated patients (5.2%) and six control
s (10.7%), the difference being not significant.
Conclusion: Twenty-four-hour prophylaxis with octreotide proved ineffective
in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamyl
asemia in high-risk patients.