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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.
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:
Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
Donation after circulatory death (DCD)
No liver biopsy obtained during organ procurement process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan 402/530 | Device | Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Controlled Attenuation Parameter (CAP) - Accuracy | CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference | Baseline (pre-procurement) to 6 months post liver transplant |
| Measure | Description | Time Frame |
|---|---|---|
| LSM | Liver stiffness measurement | Pretransplant to 6 months posttransplant |
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Inclusion criteria - Liver Recipient
Inclusion criteria - Liver Donor
Valid TE with Fibroscan 402/530, defined as:
Exclusion criteria - Liver Recipient
Exclusion criteria - Liver Donor
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Allograft procured and transplanted into recipients.
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| Name | Affiliation | Role |
|---|---|---|
| Andres Duarte-Rojo, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Stanford University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allografts | Livers assessed before procurement and after implantation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Controlled Attenuation Parameter (CAP) - Accuracy | CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference | Here are considered the allografts that were transplanted and whose recipients consented to participate in study | Posted | Median | Inter-Quartile Range | dB/m | Baseline (pre-procurement) to 6 months post liver transplant |
|
No adverse event data were collected because the study was observational.
No adverse event data were collected because the study was observational.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 6 months post-transplant in the liver recipient. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres Duarte-Rojo | University of Pittsburgh | 412-647-7922 | duarterojoa@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2017 | Jun 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Stanford |
| California |
| 94305 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ALT | Median | Inter-Quartile Range | IU/L |
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| AST | Median | Inter-Quartile Range | IU/L |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| CAP | Median | Inter-Quartile Range | dB/m |
|
| LSM | Median | Inter-Quartile Range | kPa |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | LSM | Liver stiffness measurement | Here are considered the allografts that were transplanted and whose recipients consented to participate in study | Posted | Median | Inter-Quartile Range | kPa | Pretransplant to 6 months posttransplant |
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