Condition category
Digestive System
Date applied
17/02/2017
Date assigned
02/03/2017
Last edited
02/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Health Research Council of Mexican Institute of Social Security

Sponsor details

Cuauhtemoc 330
Colonia Doctores
Mexico
06725
Mexico

Sponsor type

Research council

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes