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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Recruiting

CT.gov ID

NCT06085976

Collaborator

(none)

Enrollment

Location

Arms

27.6

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.

The main questions it aims to answer are:

Decrease in intraoperative bleeding measured in ml of blood lost.
Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Carcinoma Hepatic Metastasis	Drug: Octreotide Other: Placebo	Phase 2

Detailed Description

The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.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 patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. 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.

The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.

The pharmaceutical form to be used is Sandostatin.

The control group will receive SSF as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery.

and then a continuous infusion until the end of the surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 14, 2023

Anticipated Primary Completion Date :

Aug 14, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm (octreotide) This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h	Drug: Octreotide A loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes. Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group. The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes. Other Names: Placebo
Experimental: Placebo arm (saline solution) This patient will receive physiologic saline solution at the same infusion	Other: Placebo In the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF.

Arm

Intervention/Treatment

Experimental: Treatment arm (octreotide)

This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h

Drug: Octreotide

A loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes. Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group. The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes.

Other Names:

Placebo

Experimental: Placebo arm (saline solution)

This patient will receive physiologic saline solution at the same infusion

Other: Placebo

In the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF.

Outcome Measures

Primary Outcome Measures

Incidence on intraoperative bleeding. [During the time the surgery lasts.]
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.

Secondary Outcome Measures

Rate of intraoperative hemodynamic stability. [During the time the surgery lasts.]
Intraoperative hemodynamic stability through haemodynamics variables.
Incidence of intraoperative transfusion. [During the time the surgery lasts.]
Decrease in transfusion during surgery due to bleeding versus placebo
Number of patients with vasoactive use. [During the time the surgery lasts.]
Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo
Incidence on the improvement of hepatic function [Up to 90 days]
Observe the effects on postoperative liver function, reduction of liver enzymes.
Rate of postoperative complications [Up to 90 days]
Observe the effects on postoperative complications versus placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
The patient must not be allergic to the drug.

Exclusion Criteria:

History of hypersensitivity to the drug to be administered.
Children under 18 years of age.
Urgent intervention.
Intervention performed in an open manner (not laparoscopic).
Patient's refusal to participate in the study.
Contraindication to receive octreotide.
Women of childbearing age (those women who are in the period between menarche and menopause). Having to present a negative pregnancy test to take part in the study.
Pregnant or lactating women, given the absence of studies of this drug in this patient profile.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Universidad de Navarra	Pamplona		Spain	31007

Sponsors and Collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Clinica Universidad de Navarra, Universidad de Navarra

ClinicalTrials.gov Identifier:

NCT06085976

Other Study ID Numbers:

HEPA-OCT

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Octreotide

Study Results

No Results Posted as of Oct 17, 2023