Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
Conditions: Liver Transplant, Liver Steatosis, Liver Disease, Primary Non-function, Early Allograft Dysfunction
Sponsor: Andres Duarte-Rojo

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 1 
Protocol Title: 
Usefulness of Controlled Attenuation Parameter (CAP) for 
the assessment of liver steatosis in liver donors 
Principal Investigator: 
Andres Duarte-Rojo1 
Telephone:  501-686-5177 
Email:  aduarterojo@uams.edu 
Sub-Investigators: 
Daniel Borja-Cacho2 
Telephone:  501-526-7515 
Email:  dborjacacho@uams.edu 
Laura W. Lamps3 
Telephone:  734-647-6581 
Email:  lwlamps@med.umich.edu 
W. Ray Kim4 
Telephone:  650-725-6511 
Email:  wrkim@stanford.edu 
 
Location(s) of Study: 
1Division of Gastroenterology and Hepatology  
2Division of Transplant Surgery 
University of Arkansas for Medical Sciences 
4301 W. Markham #567 
Little Rock, AR 72205 
 
3Department of Pathology 
University of Michigan Hospitals 
Room 5231F, Box 5602, Medical Science Building 1 
1301 Catherine Street 
Ann Arbor, MI 48109 
 
4Division of Gastroenterology and Hepatology 
Stanford University 
300 Pasteur Dr. M211 MC 5187, 
Stanford CA 94305 
 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 2 
Abstract 
The shortage of liver allografts for transplantation causes thousands of patients dying 
in the liver transplant (LT) waitlist every year.  The use of marginal livers is a strategy 
to close the gap between demand and supply of organs.  Steatosis is one of the main 
parameters determining a marginal liver, and to date there is no method to quantify it 
in a noninvasive fashion.  Controlled-attenuation parameter (CAP) from transient 
elastography (TE) has successfully been used to evaluate steatosis in patients with 
liver disease, but its usefulness to address steatosis before LT in organ donors has 
never been tested.  Our primary aim is to determine the accuracy of CAP in the 
quantification of liver steatosis using liver biopsies as reference.  Secondarily we will 
correlate TE and CAP results, analyze possible associations between CAP/TE and 
post-LT clinical outcomes, and evaluate the change in CAP after LT.  A portable TE 
device (Fibroscan 530) will be used to quantify the degree of liver steatosis (CAP) and 
stiffness (TE) in donors before organ procurement.  Liver biopsies will be obtained 
after CAP or at the time of organ procurement.  The following post-transplant 
outcomes will be investigated:  primary non-function, early allograft dysfunction, ICU 
length of stay, retransplantation, and death.  A follow up CAP/TE with Fibroscan 502 
or 530 will be performed in transplant recipients having an outpatient visit 3-6 months 
after LT.  Based on power calculations the study aims to include as many donors as 
needed to achieve 100 transplanted liver allografts. 
 
 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 3 
Background 
Worldwide, there is a shortage of liver allografts to meet the number of patients with 
end-stage liver disease in need for a liver transplant (LT).  As a result of this mismatch 
between organ demand and supply, about 5000 listed patients do not undergo LT 
each year and are added to the transplant waiting list pool in the United States.(1)  It is 
estimated that 10-20% of patients in the waiting list will either die or become "too sick 
to transplant", depending mostly on the degree of liver failure.  With increasing waiting 
list times and LT occurring at higher MELD scores, it is expected that the number of 
patients dying or becoming too sick to transplant will progressively increase in the 
forthcoming years. 
In order to meet the LT demands and to best serve patients, most LT centers are 
increasingly using marginal donor allografts at risk for poorer outcomes after LT.  
These so called "extended donor criteria" (EDC) allografts include the use of livers 
with a high percentage of steatosis, livers derived from older or sicker donors, livers 
from donors infected with viral hepatitis B or C, and donation after circulatory death (in 
counterpart to donation after brain death).  Although various donor-risk scales have 
been designed to weigh the consequences of using EDC allografts, none of them 
provide an accurate risk assessment.  Moreover, the trade-off defining the use of EDC 
allografts is commonly made under far from ideal circumstances (overnight, at facilities 
with limited resources, with non-specialized on-call personnel), and flawed by 
subjective evaluations such as determination of the degree of hepatic steatosis. 
The percentage of liver steatosis in the donor allograft liver biopsy is of greatest 
importance to define prognosis of LT, and plays a paramount role in the decision to 
use or not an allograft.  To address this, the amount of large fat droplets 
(macrosteatosis) within the hepatocyte is semi-quantitatively estimated against the 
degree of non-fatty liver parenchyma on a given liver biopsy specimen.  Although 
there is controversy as to whether very small lipid droplets (macrosteatosis) should be 
accounted for in this evaluation, most centers would only consider macrosteatosis in 
their decision.  In general, allografts with >30% of steatosis are more prone to 
experience primary non-function, early allograft dysfunction, and constitute a risk 
factor for acute kidney injury, biliary complications, poor allograft survival, and 
retransplantation. 
Controlled-attenuation parameter (CAP) constitutes a non-invasive method of 
evaluating liver steatosis.  It has several advantages over liver biopsy and other 
methods to assess steatosis in that it is non-invasive, easy to perform, reliable, not 
expensive, and provides immediate and objective evaluation on a continuous scale.  
CAP is based on a novel technology measuring the degree of ultrasound attenuation 
of liver fat from ultrasonic signals acquired during transient elastography (TE) with a 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 4 
Fibroscan (Echosens, Paris, France) device.  A cross-sectional study aiming to define 
the accuracy of the CAP when compared to liver biopsy found an area under the 
receiver-operating characteristic (AUROC) curve of 0.81 (0.74-0.88) to identify a 
degree of ≥10% of steatosis in the 153 patients studied.  Although CAP was not able 
to accurately tell apart moderate (>33%) from severe (>66%) steatosis, the technique 
seemed to be more reliable at higher degrees of steatosis, and in patients with no to 
minimal fibrosis (50% of patients had stage ≥2 of fibrosis).(2)  In a more recent study 
including 440 paired CAP-liver biopsies the AUROC to identify >33% steatosis with 
CAP was 0.84 (0.80-0.88),(3) and in a meta-analysis including 1771 subjects it was 
0.88 (0.85-0.91).(4)  The last study reported positive and negative predictive values of 
58% and 94% for the detection of >33% of steatosis (median cut-off point 255 dB/m), 
and 57% and 93% for the detection of >66% of steatosis (median cut-off point 290 
dB/m), respectively. 
To date, no study has attempted to study CAP to quantify the degree of liver steatosis 
in deceased donors.  Such study has been largely limited by the fact that only a few 
institutions have the expertise and resources to operate a Fibroscan.  With the 
development of the Fibroscan 530, a portable TE device, this is no longer a limitation.  
Given the grave need to increase the number of LT by using EDC allografts, CAP has 
the potential of becoming a very useful tool during donor assessment (before 
allocation) by providing a non-invasive and objective evaluation of liver allograft 
steatosis.  If useful, CAP could become quite advantageous to the organ procurement 
agencies by providing a timely evaluation on steatosis and fibrosis (this from TE), 
saving resources by avoiding unnecessary liver biopsies and procurement of EDC 
allografts posing excessive risks to LT recipients (i.e. with excessive steatosis for each 
given donor-recipient match). 
Study Aims 
The primary aim of this study is to determine the accuracy of CAP from Fibroscan in 
the quantification of liver steatosis in donors using liver biopsies as the gold standard.  
Secondary aims include: 
(1) correlation between TE results and fibrosis 
(2) association of CAP and TE results with post-LT clinical outcomes, 
(3) measurement of change in CAP after LT. 
Study Design 
This is a cohort study with a cross-sectional component for the primary aim executed 
independently at UAMS and Stanford University.  The Liver Transplant Program at 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 5 
each participating center 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: 
o At least 10 valid measurements 
o 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 
Investigational Approach 
The chronological process of organ procurement and study is explained in Table 
below: 
Clinical or Research Event 
Standard 
of Care 
Research 
Only 
1. When a liver donor becomes available, and only after brain 
death is confirmed, the Arkansas Regional Organ Recovery 
Agency (ARORA) contacts the UAMS Transplant coordinator 
and notifies the transplant surgeon. 
✔ 
 
2. The recipient next in the liver transplant waitlist is notified 
and is admitted to UAMS. 
✔ 
 
3. A liver biopsy (snap frozen) is performed by the Organ 
Recovery Agency (when applicable) before procurement.  
✔ 
 
4. The surgeon travels to perform the liver procurement.  
✔ 
 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 6 
5. Fibroscan 530 is obtained before the procurement in the 
donor.   
 
✔ 
6. A second liver biopsy is obtained by the time of procurement 
(on formaldehyde). This is reviewed by UAMS pathologists. 
✔ 
 
7. Transplantation occurs. 
✔ 
 
8. Patient is discharged from hospital and continues with 
outpatient visits (from biweekly to every three months as per 
UAMS' liver transplant guidelines). 
✔ 
 
9. At one of the subjects’ regularly scheduled follow-up 
appointments (3 to 6 months post-transplant), a second TE is 
performed, this time on the recipient (using either Fibroscan 
502 or 530). 
 
✔ 
10. Subject continues with per protocol follow up until 
retransplantation, death, or 5 years of follow-up. 
✔ 
 
 
Before organ procurement, a Fibroscan-trained investigator will bring Fibroscan 530 to 
the bedside of donor. TE will be performed with either the M- or XL-probe depending 
on the skin to liver capsule distance (M-probe if <2.5 cm, and XL-probe when between 
2.5 and 3.5 cm), as per manufacturer's recommendations (Echosens, Paris, France). 
In brief, after applying a water-based gel, the corresponding probe will be placed 
against the right hypochondrium at the level of the mid axillary line (exerting a slight 
pressure), and then 10 valid TE measurements will be obtained. The procedure 
should take no more than 5-7 minutes. Data from TE will be stored for future 
extraction of CAP.  In order to assure an adequate fasting period before TE (≥3 hours) 
the surgeon leading organ procurement would request stopping of enteral nutrition 
after being initially contacted by the organ procurement organization (in the case of 
UAMS, the Arkansas Regional Organ Recover Agency [ARORA]), when applicable, 
and only after confirmation of brain death. 
As part of the standard evaluation of the donor allograft a liver biopsy is obtained to 
address the degree of steatosis (one standard frozen core). Investigators will make 
sure this biopsy is performed by the time of TE.  Only bedside biopsies on the mid-
axillary line or biopsies from segments VI/VII after allograft procurement will be 
allowed.  Although liver biopsies should ideally be performed immediately after 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 7 
performing TE and before organ procurement, liver biopsies obtained from the time of 
donor identification and up until back table preparation (inclusive) will be acceptable.  
In all cases where the organ is allocated to a recipient, the transplant surgeon will be 
asked to grade the appearance of the liver before implantation. 
During liver transplant procedure and immediately after finalization of venous, arterial 
and biliary anastomoses, a second biopsy will be obtained (formaldehyde). This 
biopsy is taken routinely as part or the liver transplant protocol at UAMS to address 
quality of the implanted allograft including damage from reperfusion. The allograft site 
from which biopsy will be obtained will be left to the discretion of the transplant 
surgeon, although it should be documented in the operative note. 
Before transplantation, the following data will be collected about the donor (data will 
be collected from the United Network for Organ Sharing [UNOS] portal, which 
compiles deidentified clinical data relevant to liver transplantation): 
• height,  
• weight,  
• gender,  
• age,  
• ethnicity,  
• cause of death,  
• comorbidities,  
• platelets,  
• bilirubin,  
• ALP,  
• ALT and AST on the day of TE,  
• peak ALT and AST, 
• presence of any infectious disease 
• degree of steatosis from snap frozen biopsy 
• NPO status will be documented as well (in hours), from last oral intake or 
stopping of enteral nutrition to TE procedure, 
• Cold and warm ischemia will be documented as part of the standard of care 
On the day of transplantation, the following will be recorded from the transplant 
recipients: 
• Routine labs on the day of transplantation (CBC, chemistry, liver panel, INR). 
After transplantation, the following liver transplant outcomes will be prospectively 
documented: 
• development of primary non-function (PNF), 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 8 
• early allograft dysfunction (EAD), 
• peak ALT, 
• ICU length of stay, 
• retransplantation, and 
• death. 
PNF will be defined as AST>3000, plus INR ≥2.5 or arterial pH ≤7.30 within 7 days 
from implantation; whereas EAD as total bilirubin >10 mg/dL on day 7, INR ≥1.6 on 
day 7, and ALT or AST >2000 U/L during first week post-LT.  Need for 
retransplantation or death at 3- to 6- months post-transplant (depending on follow up 
protocol at each participating center) will be recorded as well.  Where available, a 
follow up TE with Fibroscan 502 or 530 will be performed at a standard-of-care follow 
outpatient visit at 3-6 months post-transplant. The patient will lie over his/her back and 
both the M and XL probes will be used following the same steps described above. 
All liver biopsies will be evaluated by two independent liver pathologists blinded to the 
results of CAP.  In all cases, both the snap frozen and formaldehyde liver biopsy 
specimens will be reviewed and the degree of macrovesicular steatosis graded as per 
standard recommendations (<5, 5-33%, 34-66%, >66%).  Liver pathologists will 
independently stage fibrosis of liver specimens using the Batts-Ludwig scoring system 
and the Brunt classification. 
Data Analysis 
The primary aim is to correlate the CAP results with the degree of hepatic steatosis on 
the liver biopsy fixed in formaldehyde.  Spearman's rho will be used for this analysis.  
Parallel analyses will be performed with the snap frozen sample, and computerized 
histomorphometry to determine accuracy of CAP in different possible clinical 
scenarios.  In order to assess whether a threshold value of CAP with a sufficiently high 
positive predictive value can be defined to obviate the need for a liver biopsy during 
organ procurement, Receiver Operating Characteristics (ROC) curves will be plotted, 
and areas under the curve (AUROC) reported as a measure of accuracy of CAP.  For 
this analysis, the magnitude of steatosis in the formaldehyde samples will be 
dichotomized as ≥34 or <34% in order to address steatosis as for EDC allografts.  A 
sensitivity analysis using computed histomorphometry results and dichotomizing 
grading of steatosis as ≥20 or <20% will be performed in case the prior analysis lacks 
power, as this degree of steatosis has been found to be associated with poor post-
transplant outcomes as well. 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 9 
CAP will be performed with either the M- or XL-probe depending on the skin to liver 
capsule distance (M-probe if <2.5 cm, and XL-probe when between 2.5 and 3.5 cm) 
as per manufacturer's recommendations (Echosens, Paris, France). 
The first secondary aim is to examine correlation between TE results and fibrosis 
stage (Spearman's rho).  In addition to correlating the TE results with fibrosis stage, 
we will explore whether the combination of CAP and TE results can define 
unacceptability and subsequently help in the decision to discard and organ.  To 
achieve this goal a sensitivity analysis with various combinations of CAP and TE will 
be tested in logistic regression models, and then cut-off valued determined by 
constructing AUROC. Agreement between pathologist for both steatosis and fibrosis 
will be examined with the kappa statistic. A sensitivity analysis for donors on 
vasoactive amines or a peak ALT or AST >300 before procurement is planned to 
better determine accuracy of CAP/TE in liver donors. 
The second secondary aim is to correlate CAP and TE results with various post-LT 
outcomes.  Various (logistic, linear or proportional hazards) regression analyses will 
be used depending on the outcome variable of interest (PNF, EAD, retransplantation 
or death).  Predictor variables will include CAP and TE as well as well-known donor 
and recipient predictors of LT outcomes (i.e. age, MELD, ICU-stay, etc). 
The third secondary aim is to determine the change in CAP after LT. Baseline and 
follow up CAP determinations will be compared with paired t-test or Wilcoxon, 
depending on distribution of data.  Normal distribution will be tested with Shapiro-Wilk. 
Categorical changes (i.e. ≥34% to <34%) will be addressed with McNemar's test. 
Accurate sample size determination is difficult in this pilot study because the test 
characteristics are not defined.  We propose to examine as many donors as needed to 
achieve 100 transplanted liver allografts, which will allow detection of meaningful 
differences between livers with high versus low CAP values.  If the prevalence of 
unacceptably high CAP value is as low as 5% of the livers, the sample size will permit 
detection of a threshold that has 80% positive predictive value or higher. Between the 
two participating institutions, it is expected to complete inclusion of 100 transplanted 
liver allografts in one year. It is expected to include no more than 60 patients at 
UAMS. 
Data Collection and Handling 
A database will be created to accumulate all of the clinical information generated 
during this study. No identifiers, apart from UNOS identification number for donors, 
and name and DOB for recipients, will be collected.  All data will be stored in 
databases kept in a study folder created at PI's computer (password-protected).  Main 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 10 
database will include aforementioned identifiers, however, each pair of subjects 
(recipient and respective donor) will have a unique study ID assigned, and once an 
analytic table is created, all PHI will be removed from the table (after approval by the 
PI).  Only this de-identified dataset with unique study ID's will be used for statistical 
analyses.  Therefore, the risk to the privacy of the individuals will be minimized. 
The access to the research folder and its contents will be restricted to the research 
staffs listed in this submission form.  The PHI will be kept in the main database for no 
more than 10 years.  The main database containing PHI will be kept in the study folder 
and will be never transferred out without de-identification of the data.  No hard copy 
research data will be generated in this project. 
Each of the participating centers (UAMS and Stanford University) will work 
independently in gathering their own data.  The PI's from each center will share on a 
monthly basis their subject accrual figures and after study is completed each center 
will share its de-identified database and a unique database will be built. 
Risks and Benefits 
TE is a noninvasive procedure and no adverse effects were reported in the registration 
trials. FDA approval for Fibroscan 502 was obtained in April/2013, and for Fibroscan 
530 (the lighter and portable version of Fibroscan 502) in March/2016. CAP received 
FDA approval in June/2015. 
Liver biopsies in an allograft can theoretically result in bleeding, hemobilia, 
arteriovenous fistulas, or infection in the recipient.  However, apart from bleeding, 
which can be controlled by the transplant surgeon during the surgical procedure, no 
other complications have been reported.  Moreover, liver biopsies are performed 
routinely during the organ procurement process or by the time of organ implantation, 
and thus this study would not expose recipients to unusual or unnecessary risks. 
Each institution will keep its own database until finalization of the study. Afterwards, a 
combined database will be built by each center sharing a de-identified version of its 
database (datasets will be combined at UAMS).  Thus, PHI from UAMS' patients will 
remain within UAMS firewall and only used for specific research purposes in this 
project.  Aggregated data will be analyzed and published, but specific data elements 
will not be made available.  Further, subjects will not forfeit any rights by participating - 
their healthcare and eligibility for health benefits will not be affected in any way. 
Although a breach in confidentiality is always a risk when collecting personal 
information from patients, we believe this is small given the system that has been 
developed to obtain and handle data. 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 11 
Participants (liver transplant recipients) will not benefit from this study as clinically 
meaningful results will only be available until after completion of study and analysis of 
data. 
Ethics 
Applicable government regulations, University of Arkansas for Medical Sciences 
research policies and procedures will be followed.  This protocol and any amendments 
will be submitted and approved by the University of Arkansas for Medical Sciences 
Institutional Review Board (IRB) to conduct the study. 
All subjects (recipients) for this study will be provided a consent form describing this 
study and providing sufficient information in language suitable for subjects to make an 
informed decision about their participation in this study.  The formal consent of a 
subject, using the IRB-approved consent form, will be obtained before that subject is 
submitted to any study procedure.  This consent form must be signed by the subject or 
legally acceptable surrogate, and the investigator-designated research professional 
obtaining the consent.  The subject will be approached for signing of informed consent 
at any point from being placed on the waitlist to the admission ending up in liver 
transplantation (either during a routine outpatient visit or as an inpatient).  It will be 
emphasized to recipient that receipt of a transplant in no way depends upon research 
participation. 
Liver Donors and/or their family will execute a consent process with the Arkansas 
Regional Organ Recovery Agency (ARORA) (Consent form provided with 
documentation). 
 
 

Study Title: Usefulness of Controlled Attenuation Parameter (CAP) for the assessment of liver steatosis 
in liver donors 
PI: 
Andres Duarte-Rojo, MD, MSc, DSc 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 9 
 
IRB# 204560 
Date: 
06/16/2017 
Page 12 
References 
1. 
Kim WR, Smith JM, Skeans MA, Schladt DP, Schnitzler MA, Edwards EB, 
Harper AM, et al. OPTN/SRTR 2012 Annual Data Report: liver. Am J Transplant 
2014;14 Suppl 1:69-96. 
2. 
Myers RP, Pollett A, Kirsch R, Pomier-Layrargues G, Beaton M, Levstik M, 
Duarte-Rojo A, et al. Controlled Attenuation Parameter (CAP): a noninvasive method 
for the detection of hepatic steatosis based on transient elastography. Liver Int 
2012;32:902-910. 
3. 
de Ledinghen V, Vergniol J, Capdepont M, Chermak F, Hiriart JB, Cassinotto 
C, Merrouche W, et al. Controlled attenuation parameter (CAP) for the diagnosis of 
steatosis: a prospective study of 5323 examinations. J Hepatol 2014;60:1026-1031. 
4. 
Shi KQ, Tang JZ, Zhu XL, Ying L, Li DW, Gao J, Fang YX, et al. Controlled 
attenuation parameter for the detection of steatosis severity in chronic liver disease: a 
meta-analysis of diagnostic accuracy. J Gastroenterol Hepatol 2014;29:1149-1158.