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.
The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
62
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.
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.
Clinica Universidad de Navarra
Pamplona, Spain
RECRUITINGIncidence on intraoperative bleeding.
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.
Rate of intraoperative hemodynamic stability.
Intraoperative hemodynamic stability through haemodynamics variables.
Time frame: During the time the surgery lasts.
Incidence of intraoperative transfusion.
Decrease in transfusion during surgery due to bleeding versus placebo
Time frame: During the time the surgery lasts.
Number of patients with vasoactive use.
Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo
Time frame: During the time the surgery lasts.
Incidence on the improvement of hepatic function
Observe the effects on postoperative liver function, reduction of liver enzymes.
Time frame: Up to 90 days
Rate of postoperative complications
Observe the effects on postoperative complications versus placebo
Time frame: Up to 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.