To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
NCT ID:
NCT06085976
Condition:
Hepatic Carcinoma
Hepatic Metastasis
Conditions: Official terms:
Carcinoma, Hepatocellular
Octreotide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Octreotide
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.
Arm group label:
Treatment arm (octreotide)
Other name:
Placebo
Intervention type:
Other
Intervention name:
Placebo
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.
Arm group label:
Placebo arm (saline solution)
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withdrawn at the end of surgery before leaving the operating room.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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Marta MA Luque Pelaez, Doctor
Phone:
664192399
Phone ext:
+34
Email:
mluquepe@unav.es
Start date:
August 14, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Clinica Universidad de Navarra, Universidad de Navarra
Agency class:
Other
Source:
Clinica Universidad de Navarra, Universidad de Navarra
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085976
https://doi.org/10.1016/j.transproceed.2015.07.036
https://doi.org/10.1016/j.hbpd.2018.01.015
https://doi.org/10.1053/j.ajkd.2021.08.016
https://doi.org/10.1016/j.cgh.2015.12.049
https://doi.org/10.1007/s12192-018-0929-7
