Prevention of Postoperative Pancreatic Fistula by Somatostatin

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide and Somatostatin.

It had two arms (groups): Somatostatin (experimental) and Octreotide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection.

Who Took Part

655 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: Men or women 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 11 exclusion criteria; among the exclusions: patient with radiation therapy; patient with neoadjuvant chemotherapy within 4 weeks before surgery; patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-05-15 with completion listed for 2021-02-09.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification (time frame: 90 days).

It also tracked 12 secondary outcomes, for example ≥grade 3 pancreatic complication rates (fistula, leak, and abscess), Overall pancreatic fistula rate (grade A,B and C), Overall pancreatic fistula rate (grade B and C), Overall complication rate (grade 1 to 5), Severe complication rate (grade 3 to 5) and Mortality (grade 5).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Somatostatin in 655 people.

With 655 participants it is a large trial for this field.

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

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