End Stage Liver DIseasePhase 4NCT04107428
Somatostatin in Living Donor Liver Transplantation
A Phase 4 study testing Somatostatin in people with End Stage Liver DIsease and Portal Hypertension, run by King Faisal Specialist Hospital & Research Center.
Trial summary
Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver DIsease, Portal Hypertension
- What is being tested?
- Somatostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years old) undergoing Adult-to-Adult Living donor Liver Transplantation (LDLT) (right or left lobe)
- Indication for LDLT: End Stage Liver Disease with Portal Hypertension (HVPG ≥ 10mmHg)
Who cannot join
- Complete portal vein thrombosis (pre-operative or intraoperative diagnosis)
- Hepatopulmonary hypertension
- Adult-to-Adult Living donor liver transplantation for Fulminant hepatic failure
- Recipients of multiple solid organ transplants
- History of cardiac arrhythmias
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Somatostatin as Inflow Modulator in Adult-to-adult Living Donor Liver Transplantation: a Randomized, Double-blind, Placebo-controlled Trial
Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).
Read the detailed description
In liver transplantation (LT) portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT. Perioperative somatostatin infusion has been shown to be safe, to reduce the Hepatic Vein to Portal Vein Gradients and to preserve the arterial inflow to the graft in whole liver transplantation. In partial grafts, the pharmacological action of somatostatin could reduce the graft damage due to portal hyperperfusion and arterial hypoperfusion, reducing the incidence of small-for-size syndrome and graft loss and improving the patients survival.
Objective of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).
Fifty-six patients undergoing A2ALDLT for ESLD and CSPH will be randomized double-blindly to receive somatostatin or placebo (1:1). The study drug will be administered intraoperatively as 5ml bolus (somatostatin: 500 μg), followed by a 2.5 ml/hour infusion (somatostatin: 250 μg/hour) for 10 days. Hepatic and systemic hemodynamic will be measured, along with liver function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) will be analysed through histological and protein expression analysis.
The primary endpoint of the study will be the portal vein flow reduction measured at the end of liver transplant. Secondary end-points will be the reduction in the portal vein pressure, the rate of patients requiring surgical inflow modulation, the incidence of small for size syndrome, the severity of the ischemia reperfusion injury, the need for early re-transplantation (6 months), the incidence of adverse and serious adverse events, the 90-day mortality.
This randomized controlled trial could be the first to show the efficacy of somatostatin as modulator of the graft inflow in living-donor liver transplantation and potential improvement in graft and patient survival.
- Conditions
- End Stage Liver DIsease, Portal Hypertension
- Being tested
- Somatostatin, Placebo
- Keywords
- adult-to-adult living donor liver transplantation, small-for-size syndrome, graft hyperperfusion
- Medical subject headings
- End Stage Liver Disease, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
A bolus of 5cc of saline containing 500 mcg of somatostatin will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 250 mcg per hour of somatostatin (infusion rate 2.5 cc/hour) for 10 days.
PlaceboDrug
A bolus of 5cc of saline will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 2.5 cc of saline/hour for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Somatostatin | Active comparator | Not described Receives: Drug: Somatostatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal venous flow changes
Flow measured with transit time flow measurement system
Measured: Day 0 - At the end of liver transplantation surgery, before skin closure
Secondary outcomes (8)
Rate of patients presenting a significant portal venous flow reduction (-20%)
Flow measured with transit time flow measurement system
Measured: Day 0 - At the end of liver transplantation surgery, before skin closure
Rate of patients requiring surgical inflow modulation
Measured: Day 0 - At the end of liver transplantation surgery, before skin closure
Changes in hepatic artery flow
Flow measured with transit time flow measurement system
Measured: Day 0 - At the end of liver transplantation surgery, before skin closure
Incidence of Small-for-size syndrome
Measured: 30 days
Changes in postoperative portal venous flow
Flow measured by transabdominal ultrasound
Measured: Postoperative day 1, 7 and 14
Rates of patients requiring early re-transplantation
Measured: 6 months
Incidence of adverse and serious adverse events
Measured: 18 months
Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study startDec 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, CEINGE - Biotecnologie Avanzate, Napoli, Italia
- Responsible party
- Principal investigator, Roberto Troisi, King Faisal Specialist Hospital & Research Center
- Investigators
- Roberto Troisi, MD, PhD, Principal investigator, King Faisal Specialist Hospital & Research CenterDieter Broering, MD, PhD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107428
- Sponsor's protocol ID
- C380/981/40
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin as Inflow Modulator in Adult-to-adult Living Donor Liver Transplantation: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04107428
- Acronym / sponsor ID
- C380/981/40
- Conditions
- End Stage Liver DIsease, Portal Hypertension
- Keywords
- adult-to-adult living donor liver transplantation, small-for-size syndrome, graft hyperperfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Collaborators
- Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, CEINGE - Biotecnologie Avanzate, Napoli, Italia
- Study start
- Dec 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 27 Sep 2019 (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.
Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).
Detailed description
In liver transplantation (LT) portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT. Perioperative somatostatin infusion has been shown to be safe, to reduce the Hepatic Vein to Portal Vein Gradients and to preserve the arterial inflow to the graft in whole liver transplantation. In partial grafts, the pharmacological action of somatostatin could reduce the graft damage due to portal hyperperfusion and arterial hypoperfusion, reducing the incidence of small-for-size syndrome and graft loss and improving the patients survival.
Objective of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).
Fifty-six patients undergoing A2ALDLT for ESLD and CSPH will be randomized double-blindly to receive somatostatin or placebo (1:1). The study drug will be administered intraoperatively as 5ml bolus (somatostatin: 500 μg), followed by a 2.5 ml/hour infusion (somatostatin: 250 μg/hour) for 10 days. Hepatic and systemic hemodynamic will be measured, along with liver function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) will be analysed through histological and protein expression analysis.
The primary endpoint of the study will be the portal vein flow reduction measured at the end of liver transplant. Secondary end-points will be the reduction in the portal vein pressure, the rate of patients requiring surgical inflow modulation, the incidence of small for size syndrome, the severity of the ischemia reperfusion injury, the need for early re-transplantation (6 months), the incidence of adverse and serious adverse events, the 90-day mortality.
This randomized controlled trial could be the first to show the efficacy of somatostatin as modulator of the graft inflow in living-donor liver transplantation and potential improvement in graft and patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Somatostatin | Active comparator | Drug: Somatostatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (> 18 years old) undergoing Adult-to-Adult Living donor Liver Transplantation (LDLT) (right or left lobe)
- Indication for LDLT: End Stage Liver Disease with Portal Hypertension (HVPG ≥ 10mmHg)
Key exclusion criteria (5 listed)
- Complete portal vein thrombosis (pre-operative or intraoperative diagnosis)
- Hepatopulmonary hypertension
- Adult-to-Adult Living donor liver transplantation for Fulminant hepatic failure
- Recipients of multiple solid organ transplants
- History of cardiac arrhythmias
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 |
|---|---|---|
| SomatostatinA bolus of 5cc of saline containing 500 mcg of somatostatin will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 250 mcg per hour of somatostatin (infusion rate 2.5 cc/hour) for 10 days. | Drug | Somatostatin |
| PlaceboA bolus of 5cc of saline will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 2.5 cc of saline/hour for 10 days. | Drug | Placebo |
Primary outcome
Portal venous flow changes
Time frame: Day 0 - At the end of liver transplantation surgery, before skin closure
Flow measured with transit time flow measurement system
8 secondary outcomes
Rate of patients presenting a significant portal venous flow reduction (-20%)
Time frame: Day 0 - At the end of liver transplantation surgery, before skin closure
Rate of patients requiring surgical inflow modulation
Time frame: Day 0 - At the end of liver transplantation surgery, before skin closure
Changes in hepatic artery flow
Time frame: Day 0 - At the end of liver transplantation surgery, before skin closure
Incidence of Small-for-size syndrome
Time frame: 30 days
Changes in postoperative portal venous flow
Time frame: Postoperative day 1, 7 and 14
Rates of patients requiring early re-transplantation
Time frame: 6 months
Incidence of adverse and serious adverse events
Time frame: 18 months
Mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Roberto Troisi, MD, PhD principal investigator
King Faisal Specialist Hospital & Research Center
Dieter Broering, MD, PhD principal investigator
King Faisal Specialist Hospital & Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatostatin in people with End Stage Liver DIsease and Portal Hypertension, run by King Faisal Specialist Hospital & Research Center.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Troisi, MD, PhD (+966(0)11-4482123 ext. 43648, roberto.troisi@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal venous flow changes (time frame: Day 0 - At the end of liver transplantation surgery, before skin closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.