Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial

What Was Tested

This randomized controlled trial paper looks at Somatostatin.

Clinical guidelines, however, do not recommend this prophylaxis.

The aim of this randomized, double-blind clinical trial was to evaluate the effect of somatostatin on the incidence of post-ERCP pancreatitis.

Who Took Part

PubMed indexes the participants as middle-aged adults, older adults and people over 80, both men and women.

Patients undergoing ERCP at a single center were randomized to either intravenous bolus of somatostatin followed by a short (4-hour) continuous infusion, or to a similar placebo regimen.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Somatostatin group a baseline to be compared against.

The primary outcome was post-ERCP pancreatitis, defined as abdominal pain with an amylase level at least three times higher than the upper limit of normality 24 hours after the ERCP and requiring admission for at least 2 days.

What Was Measured

The subject headings attached to it are Abdominal Pain, Cholangiopancreatography, Endoscopic Retrograde, Hormones, Hyperamylasemia, Intention to Treat Analysis, Pancreatitis and Somatostatin.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (Endoscopy), a journal based in Germany.

More context: the Somatostatin compound page, all human trials.