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

October 10, 2023 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.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

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pamplona, Spain, 31007
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Marta MA Luque Pelaez, Doctor
          • Phone Number: +34 664192399
          • Email: mluquepe@unav.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence on intraoperative bleeding.
Time Frame: During the time the surgery lasts.
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.
During the time the surgery lasts.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 14, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPA-OCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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