Is prophylactic somatostatin effective to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis or hyperamylasemia? A randomized, placebo-controlled pilot trial.

BACKGROUND

Effects of prophylactic somatostatin on post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) and hyperamylasemia remain inconclusive. This study aimed to examine whether high-dose, long-term continuous infusion of somatostatin can reduce the incidence of PEP and post-ERCP hyperamylasemia.

METHODS

This was a randomized, placebo-controlled pilot trial. One hundred and twenty-four patients scheduled for ERCP from December 2008 to May 2010 randomly received one of the following three interventions: pre-ERCP somatostatin (0.5 mg/h for 24 hours, starting 1 hour prior to ERCP; n = 36), post-ERCP somatostatin (0.5 mg/h for 24 hours, starting 1 hour after ERCP; n = 47), or placebo (saline for 24 hours, starting 1 hour prior to ERCP; n = 41). Serum amylase and lipase concentrations were measured 1 to 3 hours prior to ERCP and 6, 24, and 48 hours after ERCP.

RESULTS

The three groups did not differ in age, gender, medical history, or ERCP procedure (catheterization using contrast or guidewire, pancreatic duct visualization, procedure time, or procedure type). The rate of PEP was 13.7% (17/124) in the overall study sample and 16.7% (6/36), 10.6% (5/47), and 14.6% (6/41) in the pre-ERCP somatostatin, post-ERCP somatostatin, and placebo groups, respectively (P = 0.715). The rate of post-ERCP hyperamylasemia was 19.4% (7/36), 21.3% (10/47), and 46.3% (19/41) in the pre-ERCP somatostatin, post-ERCP somatostatin, and placebo groups, respectively (P = 0.011).

CONCLUSIONS

High-dose, long-term continuous infusion (0.5 mg/h for 24 hours) of somatostatin, performed as either a pre- or post-ERCP, can reduce the incidence of hyperamylasemia, but not PEP.