Controlled Attenuation Parameter (CAP) in Liver Allografts

NCT02798861 | Completed Results

• 1 other identifier: 204560
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Transplant; Liver Steatosis; Liver Disease; Primary Non-function; Early Allograft Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• LSM

  Pretransplant to 6 months posttransplant

Study Arms (1)

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

Interventions

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.

CAP assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allograft procured and transplanted into recipients.

You may qualify if:

• Men and women, Age 18-years old to 80-years old inclusive
• 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)

You may not qualify if:

• Patient did not undergo liver transplantation
• Donation after circulatory death (DCD)
• No liver biopsy obtained during organ procurement process

Sponsors & Collaborators

• Andres Duarte-Rojo: lead

Study Sites (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Fatty Liver; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Andres Duarte-Rojo
• Organization: University of Pittsburgh

duarterojoa@pitt.edu

412-647-7922

Study Officials

• Andres Duarte-Rojo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 14, 2016
• Study Start: September 7, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 31, 2020
• Results First Posted: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)