ISRCTN ISRCTN11497545
DOI https://doi.org/10.1186/ISRCTN11497545
Secondary identifying numbers R-2008-3601-4
Submission date
17/02/2017
Registration date
02/03/2017
Last edited
09/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Segundo Morán
Scientific

National Medical Center XXI Century
Cuauhtemoc 330
Colonia Doctores
Mexico
06725
Mexico

ORCiD logoORCID ID 0000-0001-6833-2392

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Scientific titleUtility of 13C-methacetin breath test in predicting long-term survival of patients with decompensated cirrhosis
Study objectives13C-methacetin breath test (13C-MeBT) can predict a long-term survival in patients with decompensated cirrhosis.
Ethics approval(s)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
Health condition(s) or problem(s) studiedCirrhosis
InterventionConsecutive 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 typeOther
Primary outcome measure1. 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 measuresThe optimal cut-off point for predicting mortality to base line Child-Pugh (CP) and Meld Indexes within 3 years.
Overall study start date12/06/2008
Completion date17/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants123 patients
Key inclusion criteria1. 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
Key exclusion criteriaHepatocarcinoma
Date of first enrolment01/01/2009
Date of final enrolment17/12/2014

Locations

Countries of recruitment

  • Mexico

Study participating centre

National Medical Center XXI Century
Cuauhtémoc 330
Colonia Doctores
Mexico
06725
Mexico

Sponsor information

Health Research Council of Mexican Institute of Social Security
Research council

Cuauhtemoc 330
Colonia Doctores
Mexico
06725
Mexico

ROR logo "ROR" https://ror.org/03xddgg98

Funders

Funder type

Research council

Mexican National Council for Science and Technology

No information available

Health Research Council of Mexican Institute of Social Securite

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer reviewed journal with an impact factor.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Segundo Moran MD (segundomoran@hotmail.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/09/2017 Yes No

Editorial Notes

09/08/2018: Publication reference added