Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

What Was Tested

This registered phase 3 trial tested Pasireotide.

The purpose of this study is to help them learn more about how to lower the patient's risk of the most common complications after their pancreas operation.

After tumors are removed and the remaining part of the pancreas is connected to the intestine or closed, a leakage of pancreatic fluid may occur.

This fluid may form an "abscess" (collection of pus) or "fistula" that would need to be drained.

It had two arms (groups): SOM230 (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

439 actual participants took part.

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: Male or female patients aged 18 years or greater. Signed informed consent. Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means; patients with qtc \>450 msec; patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Pasireotide.

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

It started in 2009-10 with completion listed for 2014-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo (time frame: 60 days).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Pasireotide in 439 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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