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

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085976
• Other study ID #: HEPA-OCT
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: July 2023
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.

The patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. The monthly follow-up will coincide with the medical check-up and control analytical data will be taken. Subsequently, an attempt will be made to contact with the patient 3 months after surgery.

The duration of participation of each participant in the trial will therefore be about 3 months after surgery.

The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.

The pharmaceutical form to be used is Sandostatin.

The control group will receive SSF as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery.

and then a continuous infusion until the end of the surgery.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatic Carcinoma
• Hepatic Metastasis

Intervention

Drug:
• Octreotide
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

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

External 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
•   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
•   Terlipressin and the Treatment o