The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

What Was Tested

In this not phased trial, researchers set out to test Somatostatin.

It had two arms (groups): stilamin+common daily treatment (experimental) and common daily treatment (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients.

A two proportion equality test will be conducted to explore whether incidence rates are different.

Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables.

Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Who Took Part

908 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: Males and females, age \> 18 years. Normal amylase level before undergoing ERCP. Signed inform consent form and agreed to follow-up on time.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: pregnancy or history of allergy to somatostatin; renal insufficiency (scr\>177umol/l); acute myocardial infarction within 3 months of the procedure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2011-08 with completion listed for 2012-12.

It ran at 15 sites in China (15).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: the prophylaxis effect of Stilamin on post-ERCP pancreatitis (time frame: the incidence rate of PEP at 24 h after ERCP in two groups).

It also tracked 2 secondary outcomes, for example the prophylaxis effect of Stilamin in sub-groups of patient with high risk and compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Somatostatin in 908 people.

With 908 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.