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

Primary Purpose

Hepatic Carcinoma, Hepatic Metastasis

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Octreotide
Placebo
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinica Universidad de NavarraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment arm (octreotide)

Placebo arm (saline solution)

Arm Description

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

This patient will receive physiologic saline solution at the same infusion

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 19, 2023
Last Updated
October 10, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT06085976
Brief Title
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
Official Title
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 14, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Carcinoma, Hepatic Metastasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm (octreotide)
Arm Type
Experimental
Arm Description
This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h
Arm Title
Placebo arm (saline solution)
Arm Type
Experimental
Arm Description
This patient will receive physiologic saline solution at the same infusion
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence on intraoperative bleeding.
Description
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.
Time Frame
During the time the surgery lasts.
Secondary Outcome Measure Information:
Title
Rate of intraoperative hemodynamic stability.
Description
Intraoperative hemodynamic stability through haemodynamics variables.
Time Frame
During the time the surgery lasts.
Title
Incidence of intraoperative transfusion.
Description
Decrease in transfusion during surgery due to bleeding versus placebo
Time Frame
During the time the surgery lasts.
Title
Number of patients with vasoactive use.
Description
Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo
Time Frame
During the time the surgery lasts.
Title
Incidence on the improvement of hepatic function
Description
Observe the effects on postoperative liver function, reduction of liver enzymes.
Time Frame
Up to 90 days
Title
Rate of postoperative complications
Description
Observe the effects on postoperative complications versus placebo
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta MA Luque Pelaez, Doctor
Phone
664192399
Ext
+34
Email
mluquepe@unav.es

12. IPD Sharing Statement

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

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