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The Clinical Study to Assess Safety and Feasibility of Splitting Technique under Extracorporeal Oxygenation and Mechanical Perfusion of Donor Liver

The Study on Splitting Technique under Extracorporeal Oxygenation and Mechanical Perfusion of Donor Liver

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085912
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation

Interventions

1:Split under hypothermic and normothermic machine perfusion
2:Conventional liver transplantation under static cold storage

Sponsors

Ningbo medical center Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Donor Inclusion Criteria: (1) Age = 50 years; (2) Weight = 50 kg; (3) Body Mass Index (BMI) = 25 kg/m²; (4) Hemodynamically stable or on a single vasoactive medication with a minimal dose, norepinephrine = 0.1 ug/kg/min; (5) Liver function indicators (ALT, AST, or total bilirubin quantification) all less than twice the normal value; (6) Serum sodium = 160 mmol/L. Recipient Inclusion Criteria: (1) Graft to recipient weight ratio (GRWR) = 1.0%; (2) No portal vein or mesenteric vein thrombosis; (3) No severe vascular anomalies.

Exclusion criteria

Exclusion criteria: Donor Exclusion Criteria: (1) Complex vascular or biliary variations; (2) Liver obtained from DBD (Donation after Brain Death); (3) Fatty liver proportion > 10%; (4) Confirmed bloodstream infection; (5) Hepatitis B infection; (6) Pathological GS grading, S = Grade 2. Recipient Exclusion Criteria: (1) Model for End-Stage Liver Disease (MELD) score = 30; (2) Re-transplantation of the liver; (3) History of more than one previous liver surgery.

Design outcomes

Primary

MeasureTime frame
Recipient survival rate;Graft survival rate;The incidence of biliary complications;

Secondary

MeasureTime frame
Liver function;

Countries

China

Contacts

Public ContactCaide Lu

Ningbo medical center Lihuili Hospital

lucaide@nbu.edu.cn+86 139 5780 0900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026