Quantifying Steatosis in Liver Transplant Donors

NCT02579408 | Active Not Recruiting

• 1 other identifier: CAP LDLT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. By using controlled attenuation parameter (CAP) measurements, the investigators aim to investigate the association of CAP measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.

Conditions

Non-alcoholic Fatty Liver Disease; Evidence of Liver Transplantation

Keywords

NAFLD; LDLT; steatosis; CAP; transient elastography

Outcome Measures

Primary Outcomes (2)

• Recipient allograft short-term outcomes

  Includes: 1. Intraoperative parameters (blood transfusion, operation time etc) 2. Postoperative outcomes (ICU stay, hospital stay, hospital mortality, major postoperative complication etc) Initial poor function, defined as an AST or ALT \>1,500 U/L on two consecutive measurements within the first 72 hours Primary graft nonfunction, defined as poor function of allograft culminating in either death of recipient or retransplant

  Up to 30 days

• Recipient allograft long-term outcomes

  Includes: 1. Overall survival 2. Primary graft nonfunction up to 1 year 3. Liver stiffness measurements via transient elastography at 1 year 4. Controlled attenuation parameter measurements at 1 year

  Up to 1 year

Secondary Outcomes (1)

• Association of controlled attenuation parameter scores with clinical parameters of LDLT donor

  At time of transplant

Study Arms (1)

LDLT donor

Donors of living donor-related liver transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong

You may qualify if:

• Age 18-60 LDLT donor who has completed donor workup
• Consents to study entry

You may not qualify if:

• Concomitant liver disease, including chronic hepatitis B and C infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, and increased alcohol intake (30g per week for male, 20g per week for female).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma for storage in anticipation of future biomarkers for the prediction of improved post-transplant outcomes

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Wai Kay Seto, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

HK (1)