Hepatic Carcinoma Clinical Trial
Official title:
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
Verified date | July 2023 |
Source | Clinica Universidad de Navarra, Universidad de Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | November 30, 2025 |
Est. primary completion date | August 14, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Clinica Universidad de Navarra | Pamplona |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra |
Spain,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence on intraoperative bleeding. | Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy. | During the time the surgery lasts. | |
Secondary | Rate of intraoperative hemodynamic stability. | Intraoperative hemodynamic stability through haemodynamics variables. | During the time the surgery lasts. | |
Secondary | Incidence of intraoperative transfusion. | Decrease in transfusion during surgery due to bleeding versus placebo | During the time the surgery lasts. | |
Secondary | Number of patients with vasoactive use. | Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo | During the time the surgery lasts. | |
Secondary | Incidence on the improvement of hepatic function | Observe the effects on postoperative liver function, reduction of liver enzymes. | Up to 90 days | |
Secondary | Rate of postoperative complications | Observe the effects on postoperative complications versus placebo | Up to 90 days |
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