Early Allograft Dysfunction, Liver Disease, Liver Steatosis, Liver Transplant, Primary Non-function
Conditions
Brief summary
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.
Detailed description
This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences \[UAMS\], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board \[IRB\] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows: Inclusion criteria - Liver Recipient * Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor * Valid TE with Fibroscan 530, defined as: * At least 10 valid measurements * Interquartile Range (IQR)/Median stiffness value \<30% (only in cases with \>7.1 kPa) Exclusion criteria - Liver Recipient * Patient did not undergo liver transplantation Exclusion criteria - Liver Donor * Donation after circulatory death (DCD) * No liver biopsy obtained during organ procurement process
Interventions
DEVICEFibroscan 402/530
Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
Sponsors
Andres Duarte-Rojo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Liver Recipient * Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor * Valid TE with Fibroscan 402/530, defined as: * At least 10 valid measurements * IQR/Median stiffness value \<30% (only in cases with \>7.1 kPa)
Exclusion criteria
- Liver Recipient * Patient did not undergo liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Controlled Attenuation Parameter (CAP) - Accuracy | Baseline (pre-procurement) to 6 months post liver transplant | CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LSM | Pretransplant to 6 months posttransplant | Liver stiffness measurement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAP Assessment Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes
Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient. | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | CAP Assessment |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 16 |
| ALT | 36 IU/L |
| AST | 83 IU/L |
| BMI | 27 kg/m^2 STANDARD_DEVIATION 6 |
| CAP | 235 dB/m |
| LSM | 7.25 kPa |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 22 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 116 Participants |
| Region of Enrollment United States | 160 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Controlled Attenuation Parameter (CAP) - Accuracy
CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference
Time frame: Baseline (pre-procurement) to 6 months post liver transplant
Population: Here are considered the allografts that were transplanted and whose recipients consented to participate in study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CAP Assessment | Controlled Attenuation Parameter (CAP) - Accuracy | 220 dB/m |
Secondary
LSM
Liver stiffness measurement
Time frame: Pretransplant to 6 months posttransplant
Population: Here are considered the allografts that were transplanted and whose recipients consented to participate in study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CAP Assessment | LSM | 6 kPa |