Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

What Was Tested

The trial (phase 3) is built around Somatostatin.

Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo.

It had two arms (groups): somatostatin, intravenous bolus (experimental) and Placebo, intravenous bolus (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 510 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: pregnancy or history of allergy to somatostatin; acute myocardial infarction within 3 months of the procedure; acute pancreatitis in patients undergoing early ercp in the acute phase of the disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Somatostatin and who got the comparison, which limits bias.

The Somatostatin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Somatostatin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-05 with completion listed for 2012-05.

It ran at 2 sites in Spain (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The incidence of acute post-ERCP pancreatitis (time frame: One week).

It also tracked 1 secondary outcome, for example Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Somatostatin in 510 people.

With 510 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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