Hepatic Carcinoma, Hepatic Metastasis
Conditions
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The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.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.
Interventions
DRUGOctreotide
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.
OTHERPlacebo
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.
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed