Efficacy and safety of octreotide in laparoscopic hepatectomy surgery: effect on blood loss, need for vasoactive drugs, transfusion requirement.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Clinic Of Navarra

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

18 Jul 2023 → ongoing

Decision date (initial)

2023-06-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Observe the effects on intraoperative bleeding (measured in ml of blood lost) associated with the intraoperative administration of octreotide in laparoscopic hepatectomy surgery in relation to placebo.

Secondary objectives 7

1. Effect on the maintenance of intraoperative hemodynamic stability through heart rate (HR) and blood pressure (BP) during surgery with the administration of the drug versus placebo.
2. To assess the need for transfusion, in terms of red blood cell concentrate, plasma or platelets in this type of surgery with the administration of the drug compared to placebo.
3. Incidence in the use of vasoactive agents in the intervention group with respect to the placebo group.
4. Hemodynamic stability during vascular clampings during surgery in the intervention group with respect to the placebo group.
5. Effect of drug administration compared to placebo on clampings: number and time of clampings, time of intervention.
6. Effects on postoperative liver function and its recovery.
7. Effects on postoperative complications and on postoperative hospital stay and subsequent admissions.

Conditions and MedDRA coding

Laparoscopic hepatectomy surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients diagnosed with hepatic lesions who are going to undergo laparoscopic hepatectomy.
2. The patient must be between 18 and 80 years old.
3. The patient, or his/her representative, has given his/her consent to participate in the study.
4. The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
5. The patient must not be allergic to the drug.

Exclusion criteria 8

1. History of hypersensitivity to the drug to be administered
2. Children under 18 years of age.
3. Urgent intervention.
4. Intervention performed in an open manner (not laparoscopic).
5. Patient's refusal to participate in the study.
6. Contraindication to receive octreotide.
7. 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.
8. Pregnant or lactating women given the absence of studies of this drug in this patient profile.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main objective of the trial is the reduction of intraoperative bleeding, which will be measured through milliliters of blood lost at the end of surgery, decrease in hemoglobin, hematocrit, platelets and fibrinogen values.

Secondary endpoints 6

1. Changes in heart rate and blood pressure during surgery.
2. Need for transfusion of blood products during surgery and later during the immediate perioperative 24-72h.
3. Need for the use of vasoactive drugs during surgery and if needed, we will indicate when they can be withdrawn.
4. Number of clampings and their duration with monitoring of hemodynamic stability during surgery.
5. Hepatic function and its recovery after surgery, control of hemogram and coagulation after 24h, at discharge and at 3 months.
6. Evaluation of admissions after surgery up to three months later related to any post-surgical complication.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Clinic Of Navarra

Sponsor organisation

University Clinic Of Navarra

Address

Pio XII Etorbidea 36

City

Pamplona

Postcode

31008

Country

Spain

Scientific contact point

Organisation

University Clinic Of Navarra

Contact name

UCEC

Public contact point

Organisation

University Clinic Of Navarra

Contact name

UCEC

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications