Somatostatin Prevent Post-operation Pancreatic Fistula in Intermediate Risk Patients After Pancreaticoduodenectomy

What Was Tested

The trial (phase 4) is built around Somatostatin for pancreatitis (after the acute phase).

It had two arms (groups): Stilamin group (experimental) and Control group (no intervention).

Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin in addition to postoperative conventional treatment.

Patients in the control group will receive the postoperative conventional treatment, without addition of any new medicines.

The registry classes the interventions as drug.

More on the Plan

This is a multi-center randomized, controlled clinical trial.

A total of 200 patients are expected to be recruited.

Each trial center recruits subjects based on the sequential principle and inspect the inclusion and exclusion criteria after PD and subjects meeting the standard are assigned randomly to the treatment group or control group.

Subjects will be visited for 5 times from the start to the end of the study.

Who Took Part

The registry lists 205 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: Age ≥ 18 year. Patients underwent pancreaticoduodenectomy. Fistula Risk Score recommended by ISGPS is intermediate risk. Inform consent obtained.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: pervious pancreatic surgery history; received somatostatin or analogues treatment less than 5 half-life periods before surgery; known allergy to somatostatin or mannitol.

How the Study Was Run

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

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

The Somatostatin group and the comparison group ran side by side rather than switching.

Being open-label, the Somatostatin study did not mask who received what.

It started in 2018-06-22 with completion listed for 2019-05-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of post-operative pancreatic fistula (time frame: 30 days after operation).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Somatostatin in 205 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 Somatostatin compound page, Pancreatitis (after the acute phase) research.