Using octreotide to reduce blood loss during laparoscopic liver surgery
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
This study is testing if giving octreotide during laparoscopic liver surgery can help reduce blood loss and the need for blood transfusions in patients with liver cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 1 site (Pamplona) |
| Trial ID | NCT06085976 on ClinicalTrials.gov |
What this trial studies
This double-blind clinical trial aims to evaluate the efficacy of octreotide compared to a placebo in patients undergoing laparoscopic hepatectomy for resectable hepatic carcinoma or liver metastases. The study focuses on measuring intraoperative blood loss, the need for blood transfusions, and the use of vasoactive drugs during surgery. Participants will receive either octreotide or placebo after anesthesia induction, with the drug administered continuously until the end of the procedure. Follow-up will occur monthly for three months post-surgery to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with hepatic lesions eligible for laparoscopic hepatectomy.
Not a fit: Patients who are undergoing open surgery or have contraindications to octreotide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced blood loss and lower transfusion requirements during liver surgery, improving patient outcomes.
How similar studies have performed: While similar studies have explored the use of octreotide in surgical settings, this specific application in laparoscopic hepatectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pamplona
- Clinica Universidad de Navarra — Pamplona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.