Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment

What Was Tested

This registered phase 2 trial tested Pasireotide.

During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure.

Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure.

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

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 57 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: Male and Female patients ≥ 18 years old ;. Patients who underwent an intestinal surgery with enterostomy repair in the three weeks preceding the inclusion ;. Patients who gave its written informed consent to participate to the study ;. Patients affiliated to a social insurance regime.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: male and female patients \< 18 years old ;; patients who did not give its written informed consent to participate to the study ;; patients who received somatostatin analogues during the month before inclusion ;.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant.

It started in 2016-12-13 with completion listed for 2021-01-08.

It ran at 14 sites in France (14).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Estimate the success rate of pasireotide and placebo, Compare the incidence of premature closure of stoma due to high-output with pasireotide versus placebo, Evaluate the economic impact of pasireotide in this indication and Incidence of treatment - Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 57 people.

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

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