Plain English Summary
Background and study aims
Cirrhosis is a serious complication of liver disease, which involves widespread scarring of the liver. The damage to the liver caused by cirrhosis means that eventually the liver is unable to fulfil its normal functions, ultimately leading to liver failure. Cirrhosis develops gradually, however the damage to the liver is irreversible, and gets worse over time. The Child-Pugh score (CP score) is a test that evaluates give clinical features in order to assess the prognosis (likely course) of cirrhosis. It is commonly used, however it isn’t always accurate as it relies heavily on interpretation. 13C-phenylalanine and 13C-methacetin tests are breath tests which can be used to accurately measure how well the liver is functioning, and therefore if cirrhosis is worsening. The aim of this study is to find out whether the 13C-methacetin test can be used to predict long-term survival of patients with cirrhosis.
Who can participate?
Adults who have been diagnosed with cirrhosis.
What does the study involve?
Patients undergo a complete clinical assessment which involves testing their liver function using standard tests for liver function (CP score) and the 13C-methacetin test. This involves the collection of repeated breath samples after the patient has ingested 75 mg 13C-methacetin dissolved in water. The results are then used to predict the likely course of the disease for each patient. Participants are followed up for three years, at least once every six months at routine hospital appointments to assess survival rates and if the disease has worsened.
What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.
Where is the study run from?
National Medical Center XXI Century (Mexico)
When is the study starting and how long is it expected to run for?
June 2008 to December 2016
Who is funding the study?
1. Mexican National Council for Science and Technology (Mexico)
2. Health Research Council of Mexican Institute of Social Securite (Mexico)
Who is the main contact?
Dr Segundo Morán
Trial website
Contact information
Type
Scientific
Primary contact
Dr Segundo Morán
ORCID ID
http://orcid.org/0000-0001-6833-2392
Contact details
National Medical Center XXI Century
Cuauhtemoc 330
Colonia Doctores
Mexico
06725
Mexico
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R-2008-3601-4
Study information
Scientific title
Utility of 13C-methacetin breath test in predicting long-term survival of patients with decompensated cirrhosis
Acronym
Study hypothesis
13C-methacetin breath test (13C-MeBT) can predict a long-term survival in patients with decompensated cirrhosis.
Ethics approval
Ethics Committee and Investigation Review Board at Centro Medico Nacional Siglo XXI, Mexican Institute of Social Security, 12/06/2008, ref: R-2008-3601-4
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Cirrhosis
Intervention
Consecutive patients with decompensated cirrhosis are studied at the Laboratory of Gastro-Hepatology of Centro Medico Nacional Siglo XXI. Diagnosis of decompensated cirrhosis based on history of present illness, clinical and biochemical findings combined with ultrasonographic results, plus liver biopsy when possible.
All patients are studied following the same protocol with data collected by the laboratory staff and were followed either as outpatients or inpatients when necessary. Hepatic function is evaluated by 13C-MeBT and standard liver blood tests. The clinical diagnosis and degree of encephalopathy is determined according to the West-Haven criteria. Observation begins the day that the patient is admitted to the study, defined as “zero time” (t0). Patients are followed-up at least every 6 months for up to 3 years. Death is recorded during the three years of follow-up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Survival is assessed through patient follow ups at least every 6 months for up to 3 years with analysis performed by the Kaplan-Meier method
2. The optimal cut-off point for predicting mortality to base line 13C-MetOx obtained by 13C-methacetin breath test within 3 years
Secondary outcome measures
The optimal cut-off point for predicting mortality to base line Child-Pugh (CP) and Meld Indexes within 3 years.
Overall trial start date
12/06/2008
Overall trial end date
17/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age above 18 years
2. Diagnosis of decompensated cirrhosis based on history of present illness, clinical and biochemical findings combined with ultrasonographic results, plus liver biopsy when possible
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
123 patients
Participant exclusion criteria
Hepatocarcinoma
Recruitment start date
01/01/2009
Recruitment end date
17/12/2014
Locations
Countries of recruitment
Mexico
Trial participating centre
National Medical Center XXI Century
Cuauhtémoc 330
Colonia Doctores
Mexico
06725
Mexico
Funders
Funder type
Research council
Funder name
Mexican National Council for Science and Technology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Health Research Council of Mexican Institute of Social Securite
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal with an impact factor.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Segundo Moran MD (segundomoran@hotmail.com)
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28649974