NCT06085976

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.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

Conditions

• Hepatic Carcinoma
• Hepatic Metastasis

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2023-08-14
• Primary completion: 2025-08-14
• Completion: 2025-11-30
• First posted: 2023-10-17
• Last updated: 2023-10-17

Locations

1 site across 1 country: Spain