Ignite Creation Date:
2024-05-06 @ 7:43 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02584283
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2015-09-25
Brief Title:
Dual Hypothermic Oxygenated Perfusion of DCD Liver Grafts in Preventing Biliary Complications After Transplantation
Sponsor:
Robert J Porte
Organization:
University Medical Center Groningen
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion With Standard Static Cold Storage of Liver Grafts Donated After Circulatory Death in Preventing Biliary Complications
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DHOPE-DCD
Brief Summary:
Rationale Recent publications report good results of controlled donation after circulatory death DCD Maastricht category III liver transplantation when strict donor-recipient matching is applied and ischemia times are kept to a minimum However a major concern remains the high rate of biliary complications after transplantation of DCD livers Non-anastomotic biliary strictures NAS occur in 29 of patients receiving a DCD graft whereas the incidence of NAS in recipients of donation after brain death DBD liver grafts is 11 NAS are associated with higher morbidity and increased cost of liver transplantation Injury to the biliary epithelium and the peribiliary vascular plexus occurring during donor warm ischemia and static cold storage SCS has been identified as a major risk factor for development of NAS Machine perfusion has been proposed as an alternative strategy for organ preservation offering the opportunity to improve the quality of the organ by providing oxygen to the graft Experimental studies have shown that end-ischemic dual hypothermic oxygenated machine perfusion DHOPE helps liver grafts to recover from ischemia by restoring mitochondrial function Moreover DHOPE has been shown to provide better preservation of peribiliary vascular plexus of the bile ducts which could be an important step forward in reducing the incidence of NAS after transplantation
Objective To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS within six months after controlled DCD Maastricht category III liver transplantation
Study design An international multicenter prospective randomized controlled interventional clinical trial with a two parallel arm approach treatmentcontrol
Study population Adult patients 18 yrs old undergoing a liver transplantation with a liver graft procured from a controlled DCD donor Maastricht category III with a body weight 40 kg
Intervention In the intervention group liver grafts will be subjected to two hours of hypothermic oxygenated perfusion at the end of SCS and before implantation In the control group donor liver grafts will be preserved in accordance to standard practice by SCS only
Main study parametersendpoints The incidence and severity of symptomatic NAS as diagnosed by an Adjudication committee who are blinded for the group assignment by means of magnetic resonance cholangiopancreatography MRCP
Objective To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS within six months after controlled DCD Maastricht category III liver transplantation
Study design An international multicenter prospective randomized controlled interventional clinical trial with a two parallel arm approach treatmentcontrol
Study population Adult patients 18 yrs old undergoing a liver transplantation with a liver graft procured from a controlled DCD donor Maastricht category III with a body weight 40 kg
Intervention In the intervention group liver grafts will be subjected to two hours of hypothermic oxygenated perfusion at the end of SCS and before implantation In the control group donor liver grafts will be preserved in accordance to standard practice by SCS only
Main study parametersendpoints The incidence and severity of symptomatic NAS as diagnosed by an Adjudication committee who are blinded for the group assignment by means of magnetic resonance cholangiopancreatography MRCP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None