The Relationship of Initial Liver Profile and Outcome After Transplantation

NCT02307890 | Completed

• 1 other identifier: 2014/097
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. It typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. Although IC is more common following DCD liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. The aim of this study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of IC following liver transplantation.

Conditions

Liver Failure

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation

  Assessed by sequencing of liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes

  12 months

Secondary Outcomes (1)

• Changes in hepatobiliary senescence during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation

  12 months

Study Arms (1)

Liver transplantation group

Participants will include all deceased adult liver transplant donors (\>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh. Exclusion criteria will include paediatric liver transplant donors (\<16 years of age).

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplantation group

You may qualify if:

• All deceased adult liver transplant donors (\>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh

You may not qualify if:

• Paediatric liver transplant donors (\<16 years of age).

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

• O'Neill S, Roebuck A, Khoo E, Wigmore SJ, Harrison EM. A meta-analysis and meta-regression of outcomes including biliary complications in donation after cardiac death liver transplantation. Transpl Int. 2014 Nov;27(11):1159-74. doi: 10.1111/tri.12403.

  PMID: 25052036 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Liver and bile duct

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Ewen Harrison

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 4, 2014
• Study Start: August 6, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-05

Locations

GB (1)