Trial · Interventional

Status unknownPhase 2Registry data

Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.

NCTNCT06085976Other idHEPA-OCT

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 2
Enrollment: 62 participants (estimated)
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Other
Design: Randomized · Double masking
Countries: 1 country
Spain
Start: 14 Aug 2023
Primary completion: 14 Aug 2025 (estimated)
Completion: 30 Nov 2025 (estimated)
First posted: 17 Oct 2023
Last update posted: 17 Oct 2023
Conditions: Hepatic Carcinoma · Hepatic Metastasis

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 2
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
NCT06085976
14 Aug 2023 to est. 30 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OctreotideDrug
PlaceboOther

Arms2

Experimental
Treatment arm (octreotide)
This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h
Experimental
Placebo arm (saline solution)
This patient will receive physiologic saline solution at the same infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence on intraoperative bleeding.
Time frame · During the time the surgery lasts.
Registry description
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.

Secondary outcomes(5)

Rate of intraoperative hemodynamic stability.
Time frame · During the time the surgery lasts.
Registry description
Intraoperative hemodynamic stability through haemodynamics variables.
Incidence of intraoperative transfusion.
Time frame · During the time the surgery lasts.
Registry description
Decrease in transfusion during surgery due to bleeding versus placebo
Number of patients with vasoactive use.
Time frame · During the time the surgery lasts.
Registry description
Decrease in use of vasoactive drugs due to hemodynamic instability versus placebo
Incidence on the improvement of hepatic function
Time frame · Up to 90 days
Registry description
Observe the effects on postoperative liver function, reduction of liver enzymes.
Rate of postoperative complications
Time frame · Up to 90 days
Registry description
Observe the effects on postoperative complications versus placebo

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2004

5 results

Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial.

Suc et al. 2004Archives of surgery (Chicago, Ill. : 1960)cited by 113

PMID 15006886DOI 10.1001/archsurg.139.3.288PUB-15006886

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: Randomized controlled trial · 1995

8 results

Prospective randomised study of effect of octreotide on rebleeding from oesophageal varices after endoscopic ligation.

Sung et al. 1995Lancet (London, England)cited by 127

PMID 8551824DOI 10.1016/s0140-6736(95)92840-5PUB-08551824

Full text at the publisher8 results

Publisher page See results (8)

More studies

6 studies on this page

Indexing hint: Case report · 2019

Case report on intravenous octreotide for the treatment of intraoperative vasoplegia following thymoma resection.

3rd et al. 2019SAGE open medical case reportscited by 2

PMID 30800305PMC6378416DOI 10.1177/2050313x19827744PUB-30800305

Free to read · publisher termsCC BY-NC

Read at source

PubMed tag: none · 2016

Continuous infusion of octreotide combined with perioperative octreotide bolus does not prevent intraoperative carcinoid crisis.

Condron et al. 2016Surgerycited by 52

PMID 26603846DOI 10.1016/j.surg.2015.05.036PUB-26603846

Full text at the publisher

Publisher page

PubMed tag: none · 2013

[Endoscopic versus endoscopic plus octreotide treatment for acute variceal bleeding. Benefit according to severity at admission].

Berreta et al. 2013Acta gastroenterologica Latinoamericanacited by 1

PMID 23940908PUB-23940908

Full text at the publisher

Publisher page

PubMed tag: none · 2013

The effect of octreotide on urine output during orthotopic liver transplantation and early postoperative renal function; a randomized, double-blind, placebo-controlled trial.

Sahmeddini et al. 2013Hepatitis monthlycited by 11

PMID 24282425PMC3830523DOI 10.5812/hepatmon.12787PUB-24282425

CC BY

Download PDF

Indexing hint: Randomized controlled trial · 2009

Effect of somatostatin analogue octreotide on pain relief after major abdominal surgery.

Dahaba et al. 2009European journal of pain (London, England)cited by 15

PMID 19084439DOI 10.1016/j.ejpain.2008.10.006PUB-19084439

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2007

[Effects of two different dosages of octreotide on portal pressure and hepatic hemodynamics in cirrhotic portal hypertensive patients after portal-azygous devascularization and splenectomy].

Lu et al. 2007Zhonghua nei ke za zhicited by 1

PMID 17637266PUB-17637266

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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