Liver TransplantationNCT07304466
Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
A study testing Somatostatin and Terlipressin in people with Liver Transplantation and Portal Hypertension, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Portal Hypertension
- What is being tested?
- Somatostatin and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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%)
Show all 10Show fewer
- Myocardial ischemia
- Uncontrolled hypertension
- Arrhythmia
- Multiple solid organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Medipol Mega Hospital
Istanbul, Bagcilar, 34218
ayşe ince, assist prof, 5366774988 ext. 0090, drayseince@gmail.com
pelin karaaslan, prof, 5057657550 ext. 0090, drpelinsesli@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation, Portal Hypertension
- Being tested
- Somatostatin, Terlipressin
- Keywords
- liver transplantation, portal pressure, portal hypertension, living donor liver transplantation, somatostatin, terlipressin
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
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.
TerlipressinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Somatostatin (SS) | Active comparator | Somatostatin will be given. Receives: Drug: Somatostatin |
| Group Terlipressin (TR) | Active comparator | Terlipressin will be given. Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in portal pressure by 20% from the baseline
The proportion of patients achieving a ≥20% reduction in portal pressure from baseline at any of the predefined intraoperative assessment timepoints will be recorded.
Measured: 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 outcomes (7)
Change in Portal Pressure (mmHg)
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).
Measured: 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)
Total intraoperative blood loss will be measured in millilitres.
Measured: Periprocedural
Perioperative Blood Transfusion (Units)
The total number of blood units transfused during the perioperative period will be recorded.
Measured: During the perioperative period
Hepatic Artery Peak Systolic Flow (cm/s)
The peak systolic flow of the hepatic artery will be measured by intraoperative Doppler ultrasound after completion of the arterial anastomosis.
Measured: Immediately after arterial anastomosis (intraoperative)
Portal Vein Flow Velocity (cm/s)
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).
Measured: Immediately after completion of the hepatic arterial anastomosis (intraoperative)
Hepatic artery acceleration time (AT).
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.
Measured: Immediately after completion of the hepatic arterial anastomosis (intraoperative
Splenic Artery Ligation (Yes/No)
Whether splenic artery ligation is performed during the transplant surgery will be recorded.
Measured: During the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start29 Dec 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ince, Istanbul Medipol University Hospital
- Investigators
- ayşe ince, Principal investigator, Istanbul Medipol University Medipol Mega Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304466
- Sponsor's protocol ID
- Medipol Hospital 6
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data (IPD).
Publications
Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
PubMed 31200638Li XL, Zhu XD, Xiao N, Liu XF, Xu B, Shi GM, Huang C, Shen YH, Cai JB, Zhou J, Fan J, Sun HC. A prospective study of the effect of terlipressin on portal vein pressure and clinical outcomes after hepatectomy: A pilot study. Surgery. 2020 Jun;167(6):926-932. doi: 10.1016/j.surg.2020.01.013. Epub 2020 Feb 26.
PubMed 32113581Papaluca T, Gow P. Terlipressin: Current and emerging indications in chronic liver disease. J Gastroenterol Hepatol. 2018 Mar;33(3):591-598. doi: 10.1111/jgh.14009.
PubMed 28981166Abraldes JG, Bosch J. Somatostatin and analogues in portal hypertension. Hepatology. 2002 Jun;35(6):1305-12. doi: 10.1053/jhep.2002.33469. No abstract available.
PubMed 12029614Lizaola-Mayo B, Vargas HE. Hepatorenal Syndrome-Acute Kidney Injury in Liver Transplantation. Clin Gastroenterol Hepatol. 2023 Sep;21(10S):S20-S26. doi: 10.1016/j.cgh.2023.06.010.
PubMed 37625863Iwakiri Y. Pathophysiology of portal hypertension. Clin Liver Dis. 2014 May;18(2):281-91. doi: 10.1016/j.cld.2013.12.001. Epub 2014 Feb 25.
PubMed 24679494Giabicani M, Joly P, Sigaut S, Timsit C, Devauchelle P, Dondero F, Durand F, Froissant PA, Lamamri M, Payance A, Restoux A, Roux O, Thibault-Sogorb T, Valainathan SR, Lesurtel M, Rautou PE, Weiss E. Predictive role of hepatic venous pressure gradient in bleeding events among patients with cirrhosis undergoing orthotopic liver transplantation. JHEP Rep. 2024 Feb 28;6(6):101051. doi: 10.1016/j.jhepr.2024.101051. eCollection 2024 Jun.
PubMed 38699073
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT07304466
- Acronym / sponsor ID
- Medipol Hospital 6
- Conditions
- Liver Transplantation, Portal Hypertension
- Keywords
- liver transplantation, portal pressure, portal hypertension, living donor liver transplantation, somatostatin, terlipressin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Somatostatin (SS) | Active comparator | Drug: SomatostatinSomatostatin will be given. |
| Group Terlipressin (TR) | Active comparator | Drug: TerlipressinTerlipressin will be given. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinFollowing 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. | Drug | Group Somatostatin (SS) |
| TerlipressinFollowing 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. | Drug | Group Terlipressin (TR) |
Primary outcome
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.
7 secondary outcomes
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.
Amount of bleeding (milliliters)
Time frame: Periprocedural
Perioperative Blood Transfusion (Units)
Time frame: During the perioperative period
Hepatic Artery Peak Systolic Flow (cm/s)
Time frame: Immediately after arterial anastomosis (intraoperative)
Portal Vein Flow Velocity (cm/s)
Time frame: 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
Splenic Artery Ligation (Yes/No)
Time frame: During the intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 31200638Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
- Background: PubMed 32113581Li XL, Zhu XD, Xiao N, Liu XF, Xu B, Shi GM, Huang C, Shen YH, Cai JB, Zhou J, Fan J, Sun HC. A prospective study of the effect of terlipressin on portal vein pressure and clinical outcomes after hepatectomy: A pilot study. Surgery. 2020 Jun;167(6):926-932. doi: 10.1016/j.surg.2020.01.013. Epub 2020 Feb 26.
- Background: PubMed 28981166Papaluca T, Gow P. Terlipressin: Current and emerging indications in chronic liver disease. J Gastroenterol Hepatol. 2018 Mar;33(3):591-598. doi: 10.1111/jgh.14009.
- Background: PubMed 12029614Abraldes JG, Bosch J. Somatostatin and analogues in portal hypertension. Hepatology. 2002 Jun;35(6):1305-12. doi: 10.1053/jhep.2002.33469. No abstract available.
- Background: PubMed 37625863Lizaola-Mayo B, Vargas HE. Hepatorenal Syndrome-Acute Kidney Injury in Liver Transplantation. Clin Gastroenterol Hepatol. 2023 Sep;21(10S):S20-S26. doi: 10.1016/j.cgh.2023.06.010.
- Background: PubMed 24679494Iwakiri Y. Pathophysiology of portal hypertension. Clin Liver Dis. 2014 May;18(2):281-91. doi: 10.1016/j.cld.2013.12.001. Epub 2014 Feb 25.
- Background: PubMed 38699073Giabicani M, Joly P, Sigaut S, Timsit C, Devauchelle P, Dondero F, Durand F, Froissant PA, Lamamri M, Payance A, Restoux A, Roux O, Thibault-Sogorb T, Valainathan SR, Lesurtel M, Rautou PE, Weiss E. Predictive role of hepatic venous pressure gradient in bleeding events among patients with cirrhosis undergoing orthotopic liver transplantation. JHEP Rep. 2024 Feb 28;6(6):101051. doi: 10.1016/j.jhepr.2024.101051. eCollection 2024 Jun.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ayşe ince principal investigator
Istanbul Medipol University Medipol Mega Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatostatin and Terlipressin in people with Liver Transplantation and Portal Hypertension, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ayse ince, assist prof (+905366774988, drayseince@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07304466, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.