Controlled Attenuation Parameter (CAP) in Liver Allografts

• Sponsor: Andres Duarte-Rojo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02798861
• Collaborator: (none)
• Enrollment: 160
• Locations: 3
• Actual Duration (Months): 32.8
• Patients Per Site: 53.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Liver Steatosis; Liver Disease; Primary Non-function; Early Allograft Dysfunction	Device: Fibroscan 402/530

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

Study Design

• Study Type: Observational
• Actual Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
• Actual Study Start Date: Sep 7, 2016
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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	Device: Fibroscan 402/530; Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. LSM [Pretransplant to 6 months posttransplant]

   Liver stiffness measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Exclusion criteria - Liver Donor

• Donation after circulatory death (DCD)

• No liver biopsy obtained during organ procurement process

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Stanford University	Stanford	California	United States	94305
3	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Andres Duarte-Rojo

Investigators

• Principal Investigator: Andres Duarte-Rojo, MD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 16, 2017

More Information

Publications

None provided.

• Responsible Party: Andres Duarte-Rojo, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02798861
• Other Study ID Numbers: 204560
• First Posted: Jun 14, 2016
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver

Study Results

Participant Flow

Arm/Group Title	Allografts
Arm/Group Description	Livers assessed before procurement and after implantation.
Period Title: Overall Study
STARTED	160
COMPLETED	137
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	CAP Assessment
Arm/Group Description	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.
Overall Participants	160
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (16)
Sex: Female, Male (Count of Participants)
Female	66 41.3%
Male	94 58.8%
Race/Ethnicity, Customized (Count of Participants)
White	116 72.5%
Black	22 13.8%
Hispanic	3 1.9%
Asian	2 1.3%
Other	3 1.9%
Unknown	14 8.8%
Region of Enrollment (participants) [Number]
United States	160 100%
ALT (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	36
AST (IU/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [IU/L]	83
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27 (6)
CAP (dB/m) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [dB/m]	235
LSM (kPa) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kPa]	7.25

Outcome Measures

1. Primary Outcome

Title	Controlled Attenuation Parameter (CAP) - Accuracy
Description	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

Outcome Measure Data

Analysis Population Description

Here are considered the allografts that were transplanted and whose recipients consented to participate in study

Arm/Group Title	CAP Assessment
Arm/Group Description	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.
Measure Participants	110
Median (Inter-Quartile Range) [dB/m]	220

2. Secondary Outcome

Title	LSM
Description	Liver stiffness measurement
Time Frame	Pretransplant to 6 months posttransplant

Outcome Measure Data

Analysis Population Description

Here are considered the allografts that were transplanted and whose recipients consented to participate in study

Arm/Group Title	CAP Assessment
Arm/Group Description	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.
Measure Participants	110
Median (Inter-Quartile Range) [kPa]	6

Adverse Events

Time Frame	No adverse event data were collected because the study was observational.
Adverse Event Reporting Description	No adverse event data were collected because the study was observational.
Arm/Group Title	CAP Assessment
Arm/Group Description	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.
All Cause Mortality
	CAP Assessment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	CAP Assessment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	CAP Assessment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.