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Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.

Plain-language guide to NCT06085976: phase 2 randomized trial of Octreotide, 62 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06085976
Phase
phase 2
Status
status unknown
Start
2023-08-14
Completion (planned or actual)
2025-08-14
Participants
62 (estimated)
Design
randomized, double-blind, prevention
Conditions studied
Hepatic Carcinoma; Hepatic Metastasis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Octreotide.

Participants will receive octreotide or placebo after signing the informed consent form.

It had two arms (groups): Treatment arm (octreotide) (experimental) and Placebo arm (saline solution) (experimental).

This patient will receive physiologic saline solution at the same infusion.

The registry classes the interventions as drug and other.

More on the Plan

The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.

The monthly follow-up will coincide with the medical check-up and control analytical data will be taken.

Subsequently, an attempt will be made to contact with the patient 3 months after surgery.

The duration of participation of each participant in the trial will therefore be about 3 months after surgery.

Who Took Part

62 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: Patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy. The patient must be between 18 and 80 years old. The patient, or his/her representative, has given his/her consent to participate in the study. The patient must not be allergic to the drug.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: history of hypersensitivity to the drug to be administered; children under 18 years of age; urgent intervention.

How the Study Was Run

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

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-08-14 with completion listed for 2025-08-14.

It ran at 1 site in Spain.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Incidence on intraoperative bleeding (time frame: During the time the surgery lasts).

It also tracked 5 secondary outcomes, for example Rate of intraoperative hemodynamic stability, Incidence of intraoperative transfusion, Number of patients with vasoactive use and Rate of postoperative complications.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 62 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.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.