Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: results of a multicenter, randomized, controlled trial.
BACKGROUND
Pharmacological prophylaxis of post-ERCP pancreatitis is costly and not useful in most non-selected patients, in whom the incidence of pancreatitis is 5% or less. However, it could be useful and probably cost-effective, in patients at high risk for this complication, where the post-procedure pancreatitis rate is 10% and more.


OBJECTIVE
To assess the efficacy of octreotide in reducing the incidence and severity of post-ERCP pancreatitis and procedure-related hospital stay, in subjects with known patient-related risk factors.


METHODS
A total of 120 patients were randomly allocated to receive octreotide or not, in a multicentre, randomized, controlled trial. The drug was given subcutaneously, 200 microg t.d.s., starting 24 h before the ERCP procedure, in patients with either sphincter of Oddi dysfunction, or a history of relapsing pancreatitis or post-ERCP pancreatitis, or who were aged under 35 years, 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 of pancreatitis. Twenty-four hours after the procedure, severe hyperamylasemia (more than five times the upper normal limit) without pancreatic-like pain was recorded in three octreotide-treated patients (5.2%) and six controls (10.7%), the difference being not significant.


CONCLUSIONS
Twenty-four-hour prophylaxis with octreotide proved ineffective in preventing post-ERCP pancreatitis and in avoiding 24-h severe hyperamylasemia in high-risk patients.
Testoni
P A
PA
University Vita-Salute San Raffaele, San Raffaele, Milan, Italy. testoni.pieralberto@hsr.it
Bagnolo
F
F
Andriulli
A
A
Bernasconi
G
G
Crotta
S
S
Lella
F
F
Lomazzi
A
A
Minoli
G
G
Natale
C
C
Prada
A
A
Toti
G L
GL
Zambelli
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000008:administration & dosage / Q000494:pharmacology*; D010195:Pancreatitis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D012307:Risk Factors; D012720:Severity of Illness Index
D005765:Gastrointestinal Agents; D015282:Octreotide