Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need… (NCT06085976) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
Spain62 participantsStarted 2023-08-14
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence on intraoperative bleeding.
Timeframe: During the time the surgery lasts.
Trial details
NCT IDNCT06085976
SponsorClinica Universidad de Navarra, Universidad de Navarra