Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

April 27, 2026 updated by: Ayse Ince, Istanbul Medipol University Hospital

Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is well known that elevated portal pressure during liver resection is associated with increased bleeding, greater surgical difficulty, impaired splanchnic perfusion, a higher incidence of postoperative kidney injury, and increased need for blood transfusion. Somatostatin, a peptide hormone used to reduce portal pressure, lowers portal venous pressure by altering splanchnic blood flow. It is frequently administered in patients with end-stage liver disease for indications such as controlling variceal bleeding and reducing intraoperative portal pressure. Terlipressin, a vasopressin analog, induces vasoconstriction, thereby decreasing portal inflow and venous congestion in the splanchnic circulation. By lowering portal pressure and exerting favorable systemic effects, it is often used intraoperatively in patients with impaired renal function. It has been associated with reduced surgical bleeding and improved renal perfusion.

Following baseline portal pressure measurement from the portal vein (PVP0), patients will receive treatment according to their study group. In the somatostatin (SS) group, a bolus dose of 250 mcg will be administered over 2 minutes, followed by a maintenance infusion at 2.5 mcg/kg/hour. In the terlipressin (TRP) group, a bolus dose of 1 mg will be given over 2 minutes, followed by a maintenance infusion at 2 mcg/kg/hour. Five minutes after completion of the bolus dose, portal pressure will be measured again and recorded with the corresponding time point (PVP1).

Once the hepatic and portal vein anastomoses are completed and graft reperfusion is achieved, the third portal pressure measurement will be taken (PVP2), and right after completion of the arterial anastomosis, the fourth portal pressure measurement will be performed (PVP3). If PVP exceeds 20 mmHg or Hepatic Venous Pressure Gradient (HVPG) exceeds 15 mmHg, splenic artery ligation will be performed to modify portal inflow and prevent small-for-size syndrome. If performed, this intervention will be recorded, and subsequent measurements will be repeated (PVP4)

Intraoperative ultrasound routinely performed by radiology will be used to measure arterial (peak systolic velocity, resistive index, acceleration time) and portal (flow volume) flow parameters, which will be documented. Hemodynamic data will be recorded throughout all measurements. The study drugs will be administered as continuous infusion for at least 24 hours, and if portal pressure remains elevated, the infusion may be extended up to a maximum of 5 days.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34218
        • Recruiting
        • Istanbul Medipol University Medipol Mega Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Somatostatin (SS)
Somatostatin will be given.
Drug: Somatostatin

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), somatostatin (Somatex®) will be administered as a 250 mcg bolus over 2 minutes, followed by a continuous infusion at 2.5 mcg/kg/hour. Direct portal measurements will be done at the time points explained in the study description.

Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours.
Active Comparator: Group Terlipressin (TR)
Terlipressin will be given.
Drug: Terlipressin

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), terlipressin (Glypressin®) will be administered as a 1 mg bolus over 2 minutes, followed by a continuous infusion at 2 mcg/kg/hour.

Direct portal measurements will be done at the time points explained in the study description.

Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours, and up to 5 days if portal pressure remains elevated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in portal pressure by 20% from the baseline
Time Frame: Baseline (before bolus drug administration) 5 minutes after bolus drug administration Immediately after completion of the portal vein anastomosis Immediately after completion of the hepatic artery anastomosis
The proportion of patients achieving a ≥20% reduction in portal pressure from baseline at any of the predefined intraoperative assessment timepoints will be recorded.
Baseline (before bolus drug administration) 5 minutes after bolus drug administration Immediately after completion of the portal vein anastomosis Immediately after completion of the hepatic artery anastomosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Portal Pressure (mmHg)
Time Frame: Intraoperative: baseline and subsequent measurements at 5 minutes after bolus administration and immediately after completion of portal and hepatic artery anastomoses.
The change in portal pressure from baseline will be recorded at predefined intraoperative timepoints using direct portal pressure measurements. The change will be expressed in millimetres of mercury (mmHg).
Intraoperative: baseline and subsequent measurements at 5 minutes after bolus administration and immediately after completion of portal and hepatic artery anastomoses.
Amount of bleeding (milliliters)
Time Frame: Periprocedural
Total intraoperative blood loss will be measured in millilitres.
Periprocedural
Perioperative Blood Transfusion (Units)
Time Frame: During the perioperative period
The total number of blood units transfused during the perioperative period will be recorded.
During the perioperative period
Hepatic Artery Peak Systolic Flow (cm/s)
Time Frame: Immediately after arterial anastomosis (intraoperative)
The peak systolic flow of the hepatic artery will be measured by intraoperative Doppler ultrasound after completion of the arterial anastomosis.
Immediately after arterial anastomosis (intraoperative)
Portal Vein Flow Velocity (cm/s)
Time Frame: Immediately after completion of the hepatic arterial anastomosis (intraoperative)
Portal vein flow velocity will be measured intraoperatively using Doppler ultrasound immediately after completion of the hepatic arterial anastomosis. The value will be recorded as a single measurement in centimetres per second (cm/s).
Immediately after completion of the hepatic arterial anastomosis (intraoperative)
Hepatic artery acceleration time (AT).
Time Frame: Immediately after completion of the hepatic arterial anastomosis (intraoperative
Hepatic artery acceleration time (milliseconds) will be measured using Doppler ultrasound immediately after completion of the hepatic artery anastomosis to evaluate arterial waveform characteristics and early graft inflow dynamics.
Immediately after completion of the hepatic arterial anastomosis (intraoperative
Splenic Artery Ligation (Yes/No)
Time Frame: During the intraoperative period
Whether splenic artery ligation is performed during the transplant surgery will be recorded.
During the intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: ayşe ince, Istanbul Medipol University Medipol Mega Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol Hospital 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not share individual patient data (IPD).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on Somatostatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe