Clinical trial NCT04422223: Prospective Cohort Study of Disease and Outcomes in Cirrhosis
Official title: Copenhagen Liver Cohort Study: Disease Characteristics, Outcomes and Rehabilitation in Liver Cirrhosis - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis, Alcoholic
Progression
Liver Diseases
Decompensated Cirrhosis
Keywords: Prognosis
Prospective
Cirrhosis
Hepatology
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-06-09
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a debut of liver cirrhosis, irrespective of time and circumstances of diagnosis, comorbidities and severity of disease will be offered inclusion in the cohort.

A small percentage of patients will be diagnosed with cirrhosis at a very late stage of disease and have complications compromising their cognitive function. When complications are considered reversible, enrolment in the study will be sought when the patient has recovered. When complications are considered irreversible or there may be reasonable doubt of the patient's survival, patients will be considered eligible, but excluded to avoid unethical conduction of procedures.

Participants may be diagnosed with terminal disease or end-stage liver disease. In such a case, to secure the integrity of the patient, no extra investigational procedures will be made and only data sampled in standard medical care will be used in the cohort database.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improve risk of decompensation in cirrhosis
timeFrame: 5 years
measure: Survival
timeFrame: 5 years
Secondary outcomes:
measure: Risk prediction by Short Physical Performance Battery
timeFrame: 5 years
measure: Characterization of patients
timeFrame: 5 years
measure: Social impact of cirrhosis
timeFrame: 5 years
measure: Life space Assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Nina Kimer
state: Please Enter The State Or Province
Study officials:
References: