Clinical trial · Interventional
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
NCT06085976CI-TRIAL-00070543unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Carcinoma | — | UNRESOLVED | — |
| Hepatic Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment arm (octreotide)
- description
- This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h
- interventionNames
- Drug: Octreotide
- type
- EXPERIMENTAL
- label
- Placebo arm (saline solution)
- description
- This patient will receive physiologic saline solution at the same infusion
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Incidence on intraoperative bleeding.
- timeFrame
- During the time the surgery lasts.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (18)
- BACKGROUNDHuaringa-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
- BACKGROUNDCondron 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
- BACKGROUNDLu 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. PMID 17637266
- BACKGROUNDWeingarten 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
- BACKGROUNDWoltering 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. PMID 27290972
- BACKGROUNDDahaba 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