Prospective Cohort Study of Disease and Outcomes in Cirrhosis
Prospective Cohort Study of Disease and Outcomes in Cirrhosis
A population based incidence cohort will enroll patients newly diagnosed with cirrhosis to
 investigate disease characteristics and outcomes, explore mechanisms predicting early death
 and hospital admission, and assess new monitoring tools in treatment and prevention of
 cirrhosis.
INTRODUCTION In Denmark the incidence of liver cirrhosis is increasing. From 1996 to 2005 the
 number of hospital admissions due to liver cirrhosis rose with 2,500 extra admissions per
 year. Patients who are readmitted to the hospital have a higher 90 days mortality than those
 who avoid readmission.

 Liver cirrhosis in Denmark is caused by a wide use of alcohol and a population increasing in
 age and BMI.

 The course of cirrhosis depends on etiology, age and nutritional status, as well as social
 factors such as personal network, employment and economy. Interventional studies on many of
 these mechanisms are still unexplored.

 Cirrhosis is related to decreased quality of life and affects patients and relatives both
 emotional and socioeconomically.

 The Gastro Unit, Amager Hvidovre Hospital has a catchment area of 550,000 citizens in South
 and West of Copenhagen. The Gastro Unit diagnoses app. 140 people with liver cirrhosis
 yearly.

 Patient education and rehabilitation is implemented as standard health care after significant
 pulmonary or cardiac disease in all regions of Denmark.

 HYPOTHESIS A systematic approach to investigation, treatment and rehabilitation in liver
 cirrhosis will improve the patient's ability to benefit from medical treatment and health
 care offers and increase patient involvement and autonomy in disease.

 A systematic approach to investigation of liver disease will contribute to identify new risk
 factors for death, hospital admission and readmission, and decompensation in liver cirrhosis.

 Better knowledge on sociodemographic features, use of health care resources and the patient's
 physical performance and frailty will improve new actions of personalized treatment,
 interventions focusing on patient needs and patient reported outcomes in cirrhosis.

 Primary outcome The primary aim for this prospective cohort study is to improve
 characterization, treatment and rehabilitation under and after admission of patients with
 liver cirrhosis, with the purpose of improving survival and reducing risk of readmission.

 Secondary outcomes

 -  To identify 'frail patients' and to improve their access to health care offers.

 -  To improve the utilization of health care resources by a systematic approach to patient
 characterization and treatment.

 -  To identify co-factors with importance for early death and readmission.

 -  To identify and explore new targets for treatment and symptom-relief in liver cirrhosis.

 METHODS The cohort study will apply an observational prospective incidence cohort design in
 which patients will be followed from diagnosis to death or withdrawal from the cohort.
 Participants will be enrolled consecutively within six months of diagnosis.

 TRIAL FLOW The standardized investigational program includes procedures recommended by
 National- and European guidelines for complications in liver cirrhosis, applied at the Gastro
 Unit, Medical Division, Amager Hvidovre Hospital.

 The standard investigational program will be initiated within six months of inclusion. To
 avoid repetition of invasive diagnostic procedures (e.g. upper endoscopy, CT scan or
 ultrasound), we will accept retrospective inclusion of data, dating back to time of diagnosis
 (maximum six months).

 Standard biochemistry will be performed at inclusion and at follow-up after 1,2,3 and 5
 years.

 Bio Impedance Assessment will be performed at inclusion and at follow up after 1,2,3 and 5
 years.

 Assessments of socio demography, loneliness and quality of life will be performed through the
 following questionnaires:

 1. A specific questionnaire assessing socio demography, economic status and use of health
 care resources is designed for the trial.

 2. Three item loneliness scale

 3. Alcohol use by Audit C

 4. Health related quality of life in cirrhosis by: Chronic Liver Disease Questionnaire
 (CLDQ).

 5. Functional disability in work-, social- and family life by: Sheehan Disability Scale
 (SDS).

 Information will be retrieved from the participant's medical record concerning:

 -  Dates and length of hospitalization.

 -  Reason for hospitalization.

 -  Diagnosis.

 -  Biochemistry.

 -  Results from endoscopic procedures.

 -  Results from ultrasound, CT scan, and if applied, MR scan.

 -  Results from Dexascan.

 BIO BANK FOR FUTURE RESEARCH For this study a research bio bank for future research will be
 established. The bio bank will contain blood, liver tissue and stool.

 The bio bank is registered separately by The Danish Data Protection Agency.

 DATA A database in Redcap will be established for the study. Questionnaires will be answered
 electronically on an Ipad exporting data directly to Redcap. The Redcap database will use
 study ID numbers and initials for identification of participants. An identification list of
 all participants will be stored separately.

 Investigators aim to publish all results derived from this trial. The investigators support
 open acces policy, and at the end of the trial, all data will be sought published in
 anonymous form.

 ETHICS The study is approved by the Scientific Ethics Committees of the Capital Region of
 Denmark and The Danish Data Protection Agency before initiation.

 A thorough characterization and consecutive inclusion will strengthen our knowledge on the
 incidence, prevalence and impact of liver disease in the population, and the use of health
 care resources allocated to liver disease.

 The study will contribute to the finding of formerly unidentified risk factors with
 importance for survival and use of health care services; and thereby form the basis of
 implementation of changes in health practices, with both economic and medical gain. The study
 may also identify new areas for interventional research, with clinically relevant endpoints
 that can be translated into favorable changes in health care practice.
Inclusion Criteria:

 -  Clinical suspicion of cirrhosis supported by biochemistry and ultrasound or other
 imaging techniques.

 -  Cirrhosis of any etiology

 -  Informed written consent

 Exclusion Criteria:

 -  People where the diagnosis of liver cirrhosis is questioned with reasonable doubt or
 the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.

 -  Withdrawal of informed consent or no informed consent.

 -  Persons eligible for inclusion where the investigational program is delayed or not
 initiated within six months after the diagnosis of suspected cirrhosis.