Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

What Was Tested

The trial (not phased) is built around Octreotide.

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy.

Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled.

The patients were randomly assigned to intervention (use of octreotide) or placebo groups.

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

After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days.

After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days.

The registry classes the interventions as drug.

More on the Plan

The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.

Postoperative care of patients was same between groups such as pain control and supportive care.

The amount of drained pancreatic juice via external stent was recorded everyday.

Who Took Part

The registry lists 282 planned participants were the target.

It was open to people of any sex aged from 19 years up to 80 years.

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

Examples of who could join: Patients who will undergo pancreatoduodenectomy for periampullary tumors.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients with preoperative pancreatitis; patients who did not undergo pancreatoduodenectomy; patients who underwent bypass surgery or total pancreatectomy.

How the Study Was Run

Design: randomized, parallel-group and single-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 participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: participant.

It started in 2014-01 with completion listed for 2018-06.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Amount of pancreatic secretion (time frame: 1 day).

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

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 282 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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