Octreotide Microspheres for Preventing Pancreatic Fistula

What Was Tested

The trial (phase 3) is built around Octreotide.

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

The registry classes the interventions as drug.

More on the Plan

Participants will be enrolled and allocated, with approximately 230 individuals expected to participate in this study conducted across three different medical institutions.

Who Took Part

Enrollment: 230 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Subjects voluntarily participate in this study and sign the informed consent form;. Age ≥18 and ≤80 years old, both males and females are eligible;. Preoperative imaging assessment indicates the corresponding disease is surgically resectable;. Planned to undergo distal pancreatectomy;.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: cirrhosis or chronic active hepatitis;; acute cholecystitis;; uncontrolled infection, or history of immunodeficiency, including a positive hiv test;.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

In this single-blind Octreotide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2026-04-01 with completion listed for 2027-12-31.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of CR-POPF at 60 days postoperatively (time frame: up to 60 days).

It also tracked 6 secondary outcomes, for example Incidence of biochemical leak, Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively, Mortality rate at 60 days postoperatively, Proportion of patients requiring rescue therapy and Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 230 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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