Pasireotide for postoperative pancreatic fistula

What Was Tested

This randomized controlled trial paper looks at Somatostatin and Pasireotide.

Who Took Part

According to the abstract, 300 patients were involved.

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

The researchers conducted a single-center, randomized, double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy.

The primary end point was the development of pancreatic fistula, leak, or abscess of grade 3 or higher (i.e., requiring drainage).

How the Study Was Run

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

The patients were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

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

The comparison arm used a placebo, so changes seen with Somatostatin could be set against what happens without it.

Randomization was stratified according to the type of resection and whether the pancreatic duct was dilated at the site of transection.

What Was Measured

Topics PubMed links to this paper include Abdominal Abscess, Pancreatectomy, Pancreatic Ducts, Pancreatic Fistula, Pancreaticoduodenectomy, Perioperative Period and Postoperative Complications.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin and Pasireotide in 300 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (The New England journal of medicine), a journal based in United States.

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