Status:
UNKNOWN
Somatostatin in Living Donor Liver Transplantation
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Collaborating Sponsors:
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
CEINGE - Biotecnologie Avanzate, Napoli, Italia
Conditions:
End Stage Liver DIsease
Portal Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 re...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04107428
Start Date
December 1 2019
End Date
February 1 2022
Last Update
September 27 2019
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