Study on the Effects of Octreotide in Reducing Blood Loss During Laparoscopic Liver Surgery for Patients Undergoing Hepatectomy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called octreotide during a type of liver surgery known as laparoscopic hepatectomy. This surgery involves removing part of the liver using small incisions and a camera to guide the procedure. The trial aims to observe how octreotide, which is a synthetic version of a natural hormone, affects blood loss during the surgery compared to a placebo. The study will also look at the need for medications that help control blood pressure and heart rate, as well as the requirement for blood transfusions during and after the surgery.

Participants in the study will receive either octreotide or a placebo during their surgery. The trial will monitor several factors, including the amount of blood lost, changes in heart rate and blood pressure, and the need for blood transfusions. Additionally, the study will assess liver function recovery after surgery and any complications that may arise up to three months post-surgery. The goal is to determine if octreotide can help reduce blood loss and improve overall outcomes for patients undergoing this type of liver surgery.

The trial will run until 2026, and it will provide valuable information on the safety and effectiveness of using octreotide in laparoscopic hepatectomy. By understanding how this medication impacts surgery outcomes, healthcare providers can make more informed decisions about its use in managing blood loss and other related factors during liver surgeries.

1 joining the study

Upon joining the study, consent is confirmed. Eligibility is based on being between 18 and 80 years old, having a diagnosis of hepatic lesions, and planning to undergo laparoscopic hepatectomy surgery. It is important to ensure no allergies to the medication used in the trial.

2 pre-surgery preparation

Before the surgery, a detailed medical assessment is conducted to ensure readiness for the procedure. This includes reviewing medical history and current health status.

3 administration of medication

During the surgery, the medication octreotide is administered. This is given as a solution for injection or infusion. The purpose is to observe its effects on blood loss during the surgery.

4 monitoring during surgery

Throughout the surgery, monitoring of blood loss, heart rate, and blood pressure is conducted. The need for blood transfusions and use of additional medications to support blood pressure is assessed.

5 post-surgery observation

After the surgery, recovery is monitored closely. This includes checking blood levels and liver function. Observations continue for 24 to 72 hours to ensure stability and address any immediate needs.

6 follow-up assessments

Follow-up assessments are scheduled at discharge and three months post-surgery. These evaluations focus on recovery, liver function, and any complications that may arise.

Who Can Join the Study?

Patients diagnosed with hepatic lesions (liver problems) who are going to have laparoscopic hepatectomy (a type of liver surgery done with small cuts).
The patient must be between 18 and 80 years old.
The patient, or their representative, must have given consent to participate in the study.
The patient must be able, in the opinion of the investigator, to follow all the requirements of the clinical trial.
The patient must not be allergic to the drug used in the study.

Who Cannot Join the Study?

Patients who are not undergoing laparoscopic hepatectomy surgery cannot participate. This is a type of surgery to remove part of the liver using small cuts and a camera.
Patients who are not within the specified age range cannot participate. The study includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2023

Trial locations

Investigated drugs:

Octreotide

Octreotide is a medication used in this clinical trial to help reduce blood loss during laparoscopic liver surgery. It works by mimicking a natural hormone in the body that can decrease the amount of blood flow to certain areas, which may help in reducing bleeding during surgery. This can potentially lessen the need for blood transfusions and the use of other medications to control blood pressure during the operation.

Liver Disease – Liver disease refers to any condition that affects the liver’s ability to function properly. It can result from various factors, including infections, genetic conditions, or lifestyle choices such as alcohol consumption. As liver disease progresses, it can lead to inflammation, scarring (fibrosis), and eventually cirrhosis, where the liver becomes severely scarred and unable to function. Symptoms may include jaundice, fatigue, and abdominal pain. Over time, liver disease can impair the liver’s ability to detoxify the blood, produce essential proteins, and regulate metabolism. The progression of liver disease can vary depending on the underlying cause and individual health factors.

Trial ID:

2023-503613-29-00

Protocol code:

HEPA-OCT

Trial Phase:

Therapeutic exploratory (Phase II)

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