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

NCT06085976 | Unknown Phase 2

• 1 other identifier: HEPA-OCT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Carcinoma; Hepatic Metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of intraoperative hemodynamic stability.

  During the time the surgery lasts.

• Incidence of intraoperative transfusion.

  During the time the surgery lasts.

• Number of patients with vasoactive use.

  During the time the surgery lasts.

• Incidence on the improvement of hepatic function

  Up to 90 days

• Rate of postoperative complications

  Up to 90 days

Study Arms (2)

Treatment arm (octreotide)

EXPERIMENTAL

This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h

Drug: Octreotide

Placebo arm (saline solution)

EXPERIMENTAL

This patient will receive physiologic saline solution at the same infusion

Other: Placebo

Interventions

Octreotide DRUG

A loading dose of 100 mcgr of octreotide will be administered in the intervention group, diluted in 100 ml of SSF to be passed in 30 minutes. Subsequently, it will be administered in continuous perfusion at 25 mcgr/h in the intervention group. The drug can be administered through a peripheral or central venous line at the choice of the anesthesiologist, since the drug has a density that allows its administration by both routes.

Also known as: Placebo

Treatment arm (octreotide)

Placebo OTHER

In the case of the control group, 100 ml of SSF will be administered to be passed in half an hour and then an perfusion of SSF.

Placebo arm (saline solution)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, 31007, Spain

RECRUITING

Related Publications (18)

• Huaringa-Marcelo J, Huaman MR, Branez-Condorena A, Villacorta-Landeo P, Pinto-Ruiz DF, Urday-Ipanaque D, Garcia-Gomero D, Montes-Teves P, Lozano Miranda A. Vasoactive Agents for the Management of Acute Variceal Bleeding: A Systematic Review and Meta-analysis. J Gastrointestin Liver Dis. 2021 Mar 13;30(1):110-121. doi: 10.15403/jgld-3191.

  PMID: 33723542 BACKGROUND

• Condron ME, Pommier SJ, Pommier RF. Continuous infusion of octreotide combined with perioperative octreotide bolus does not prevent intraoperative carcinoid crisis. Surgery. 2016 Jan;159(1):358-65. doi: 10.1016/j.surg.2015.05.036. Epub 2015 Oct 23.

  PMID: 26603846 BACKGROUND

• Lu SC, Meng FK, Ding HG, Zhang JG, Ding L, Wang SZ. [Effects of two different dosages of octreotide on portal pressure and hepatic hemodynamics in cirrhotic portal hypertensive patients after portal-azygous devascularization and splenectomy]. Zhonghua Nei Ke Za Zhi. 2007 Apr;46(4):290-3. Chinese.

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• Weingarten TN, Abel MD, Connolly HM, Schroeder DR, Schaff HV. Intraoperative management of patients with carcinoid heart disease having valvular surgery: a review of one hundred consecutive cases. Anesth Analg. 2007 Nov;105(5):1192-9, table of contents. doi: 10.1213/01.ane.0000284704.57806.0b.

  PMID: 17959940 BACKGROUND

• Woltering EA, Wright AE, Stevens MA, Wang YZ, Boudreaux JP, Mamikunian G, Riopelle JM, Kaye AD. Development of effective prophylaxis against intraoperative carcinoid crisis. J Clin Anesth. 2016 Aug;32:189-93. doi: 10.1016/j.jclinane.2016.03.008. Epub 2016 Apr 20.

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• Dahaba AA, Mueller G, Mattiassich G, Rumpold-Seitlinger G, Bornemann H, Rehak PH, Linck G, Mischinger HJ, Metzler H. Effect of somatostatin analogue octreotide on pain relief after major abdominal surgery. Eur J Pain. 2009 Sep;13(8):861-4. doi: 10.1016/j.ejpain.2008.10.006. Epub 2008 Dec 11.

  PMID: 19084439 BACKGROUND

• Suc B, Msika S, Piccinini M, Fourtanier G, Hay JM, Flamant Y, Fingerhut A, Fagniez PL, Chipponi J; French Associations for Surgical Research. Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial. Arch Surg. 2004 Mar;139(3):288-94; discussion 295. doi: 10.1001/archsurg.139.3.288.

  PMID: 15006886 BACKGROUND

• Latchana N, Hirpara DH, Hallet J, Karanicolas PJ. Red blood cell transfusion in liver resection. Langenbecks Arch Surg. 2019 Feb;404(1):1-9. doi: 10.1007/s00423-018-1746-2. Epub 2019 Jan 3.

  PMID: 30607533 BACKGROUND

• Hallet J, Tsang M, Cheng ES, Habashi R, Kulyk I, Hanna SS, Coburn NG, Lin Y, Law CH, Karanicolas PJ. The Impact of Perioperative Red Blood Cell Transfusions on Long-Term Outcomes after Hepatectomy for Colorectal Liver Metastases. Ann Surg Oncol. 2015 Nov;22(12):4038-45. doi: 10.1245/s10434-015-4477-4. Epub 2015 Mar 10.

  PMID: 25752895 BACKGROUND

• Wang C, Han J, Xiao L, Jin CE, Li DJ, Yang Z. Efficacy of vasopressin/terlipressin and somatostatin/octreotide for the prevention of early variceal rebleeding after the initial control of bleeding: a systematic review and meta-analysis. Hepatol Int. 2015 Jan;9(1):120-9. doi: 10.1007/s12072-014-9594-9. Epub 2014 Dec 5.

  PMID: 25788386 BACKGROUND

• Li JJ, Chao P, Gernsheimer J, Verma R. Octreotide for Gastrointestinal Hemorrhage from Esophageal Varices. Acad Emerg Med. 2020 Apr;27(4):339-340. doi: 10.1111/acem.13901. Epub 2019 Dec 31. No abstract available.

  PMID: 31821652 BACKGROUND

• Berreta J, Kociak D, Romero G, Balducci A, Amaya R, Argonz J. [Endoscopic versus endoscopic plus octreotide treatment for acute variceal bleeding. Benefit according to severity at admission]. Acta Gastroenterol Latinoam. 2013 Jun;43(2):89-97. Spanish.

  PMID: 23940908 BACKGROUND

• Sung JJ, Chung SC, Yung MY, Lai CW, Lau JY, Lee YT, Leung VK, Li MK, Li AK. Prospective randomised study of effect of octreotide on rebleeding from oesophageal varices after endoscopic ligation. Lancet. 1995 Dec 23-30;346(8991-8992):1666-9. doi: 10.1016/s0140-6736(95)92840-5.

  PMID: 8551824 BACKGROUND

• Iannone A, Principi M, Barone M, Losurdo G, Ierardi E, Di Leo A. Gastrointestinal bleeding from vascular malformations: Is octreotide effective to rescue difficult-to-treat patients? Clin Res Hepatol Gastroenterol. 2016 Sep;40(4):373-7. doi: 10.1016/j.clinre.2016.02.003. Epub 2016 Aug 29.

  PMID: 27595456 BACKGROUND

• Fabes J, Ambler G, Shah B, Williams NR, Martin D, Davidson BR, Spiro M. Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation. BMJ Open. 2021 Dec 2;11(12):e055864. doi: 10.1136/bmjopen-2021-055864.

  PMID: 34857585 BACKGROUND

• Sahmeddini MA, Amini A, Naderi N. The effect of octreotide on urine output during orthotopic liver transplantation and early postoperative renal function; a randomized, double-blind, placebo-controlled trial. Hepat Mon. 2013 Sep 18;13(9):e12787. doi: 10.5812/hepatmon.12787. eCollection 2013.

  PMID: 24282425 BACKGROUND

• Williams WH 3rd, Browne RC, Bui TP, Holmes AA, Thakar D. Case report on intravenous octreotide for the treatment of intraoperative vasoplegia following thymoma resection. SAGE Open Med Case Rep. 2019 Feb 8;7:2050313X19827744. doi: 10.1177/2050313X19827744. eCollection 2019.

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• Edelson J, Basso JE, Rockey DC. Updated strategies in the management of acute variceal haemorrhage. Curr Opin Gastroenterol. 2021 May 1;37(3):167-172. doi: 10.1097/MOG.0000000000000723.

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Related Links

• Byram, S., Gupta, R., Ander, M., Edelstein, S. \& Andreatta, B. (2015). Effects of Continuous Octreotide Infusion on Intraoperative Transfusion Requirements During Orthotopic Liver Transplantation. Transplantation Proceedings, 47(9), 2712-2714.
• El Nakeeb, A., ElGawalby, A., A. Ali, MEfficacy of octreotide in the prevention of complications after pancreaticoduodenectomy in patients with soft pancreas and non-dilated pan
• Terlipressin and the Treatment o
• Pisani, A., Sabbatini, M., Imbriaco, M., Riccio, E., Rubis, N., Prinster, A., Perna, A., Liuzzi, R., Spinelli, L., Santangelo, M., Remuzzi, G., Ruggenenti, P., Pisani, A., Sabbatini, M., Ruggenenti, P., Remuzzi, G., Pisani, A., Visciano, B., Amicone, M.,
• Somatostatin analogue, Octreotide, improves restraint stress-induced liver injury by ameliorating oxidative stress, inflammatory response, and activation of hepatic stellate cells. Cell Stress and Chaperones

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 17, 2023
• Study Start: August 14, 2023
• Primary Completion: August 14, 2025
• Study Completion: November 30, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-07

Locations

ES (1)