Comparing terlipressin and somatostatin to lower portal pressure during living-donor liver transplant
Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
This trial tests whether terlipressin or somatostatin better lowers portal pressure and reduces bleeding and transfusion needs in people having a right-lobe living-donor liver transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul, Bagcilar) |
| Trial ID | NCT07304466 on ClinicalTrials.gov |
What this trial studies
This interventional trial gives patients undergoing right-lobe living-donor liver transplantation either somatostatin or terlipressin to compare effects on portal pressure and clinical outcomes. Direct portal pressure is measured at baseline, five minutes after a bolus dose, after portal vein and hepatic artery anastomoses, and after splenic artery ligation if performed, while continuous hemodynamic monitoring is recorded. Dosing is somatostatin 250 mcg bolus then 2.5 mcg/kg/hr infusion and terlipressin 1 mg bolus then 2 mcg/kg/hr infusion, continued intraoperatively and for 24 hours postoperatively. The study compares changes in portal pressure, bleeding, transfusion requirements, and perioperative hemodynamics between the two groups.
Who should consider this trial
Good fit: Adults scheduled for right-lobe living-donor liver transplantation with clinically significant portal hypertension (for example varices, thrombocytopenia <100,000, ascites, or encephalopathy) and Child–Turcotte–Pugh class B or C who meet inclusion criteria.
Not a fit: Patients with portal vein thrombosis, severe chronic renal failure (GFR ≤30%), active myocardial ischemia, uncontrolled hypertension, arrhythmia, portopulmonary hypertension, acute-on-chronic liver failure, or those already treated with terlipressin for hepatorenal syndrome are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If one drug proves superior, it could reduce intraoperative bleeding, lower transfusion needs, and improve perioperative renal and hemodynamic outcomes for transplant patients.
How similar studies have performed: Both somatostatin and terlipressin have prior evidence of lowering portal pressure and reducing bleeding in variceal and surgical settings, but direct head-to-head intraoperative comparisons in living-donor liver transplantation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients scheduled for right lobe living donor liver transplantation with clinically significant portal hypertension (esophageal varices, thrombocytopenia (\<100,000), ascites, encephalopathy; Child-Turcotte-Pugh class B-C) Exclusion Criteria: * Allergy to any of the medications to be used * Portal vein thrombosis * Being treated with terlipressin with a diagnosis of hepatorenal syndrome * Portopulmonary hypertension * Acute on chronic liver failure * Chronic renal failure (glomerular filtration rate ≤ 30%) * Myocardial ischemia * Uncontrolled hypertension * Arrhythmia * Multiple solid organ transplantation
Where this trial is running
Istanbul, Bagcilar
- Istanbul Medipol University Medipol Mega Hospital — Istanbul, Bagcilar, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: ayşe ince — Istanbul Medipol University Medipol Mega Hospital
- Study coordinator: ayse ince, assist prof
- Email: drayseince@gmail.com
- Phone: +905366774988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.