Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

What Was Tested

The trial (not phased) is built around Octreotide for pancreatitis (after the acute phase).

Pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases.

It had two arms (groups): Octreotide (active comparator) and Placebo (placebo comparator).

Pancreaticoduodenectomy without octreotide postoperative.

The registry classes the interventions as drug.

More on the Plan

The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours.

Enrolled patients will be randomized to either the octreotide or the placebo group.

The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .

Patients in the placebo group will receive saline administered in a similar manner.

Who Took Part

The registry lists 104 actual participants took part.

It was open to people of any sex aged from 10 years up to 70 years.

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

Examples of who could join: All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial. Patients with non dilated pancreatic duct and soft pancreas.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: age over 70; patients who underwent total or distal pancreatic resection; patients with unresectable disease who will undergo any surgical procedure other than pd for pancreatic and periampullary tumours.

How the Study Was Run

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

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 pancreatitis (after the acute phase) participants stayed in one arm throughout.

Blinding on both sides kept the pancreatitis (after the acute phase) participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant and investigator.

It started in 2014-05 with completion listed for 2017-04.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: the rate of development of postoperative pancreatic fistula (time frame: 30 day).

It also tracked 2 secondary outcomes, for example Delayed gastric emptying and duration of the hospital length of stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 104 people with pancreatitis (after the acute phase).

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

More context: the Octreotide compound page, Pancreatitis (after the acute phase) research.