Effects of Intraarterial Octreotide on Pancreatic Texture

What Was Tested

The trial (not phased) is built around Octreotide.

A primary end-point of the study is a change in pancreatic texture.

A secondary end-point is the rate of postoperative pancreatic fistula.

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

The registry classes the interventions as drug.

More on the Plan

Soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy.

Octreotide is believed to harden the pancreas.

This theory is based on the results of a single animal experiment and a small case series in humans.

This hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Age between 18 an 90 years. Signed informed consent. Pancreatic hardness equal or less than 40 SU as measured by durometer. Normal vascular anatomy of the hepato-pancreatic region.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: planned distal pancreatic resection; planned non-resectional pancreatic surgery; acute pancreatitis at the time of surgery.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and care provider.

It started in 2011-08 with completion listed for 2012-02.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Pancreatic hardness (time frame: 3 months postoperatively).

It also tracked 1 secondary outcome, for example Rate of postoperative pancreatic fistula.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 26 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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