Clinical trial NCT04525833: Liver Disease and Other Systemic Diseases
Official title: The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Humans
Progression
Carcinogenesis
Fatty Liver Disease
Hepatitis C
Hepatitis B
Hepatocellular Carcinoma
Liver Cirrhoses
Treatment Outcome
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
Collaborators: name: Dalin Tzu Chi General Hospital
First posted: 2020-08-25
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data collected from the Hospital Database of Buddhist Tzu Chi Medical Foundation

Brief summary: Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.

Detailed description: The global population is growing older over the next several decades. An essential component to keep people healthy, even with aging, is to prevent chronic disease progression and reduce associated complications. About 80% of older adults have one chronic condition, and 50% have at least two chronic disorders. Efforts to identify strategies to prevent or reduce the risk of chronic diseases and injuries and to widely apply effective interventions must be pursued. Because the liver is the largest solid organ in the human body with multiple functions, including nutrition, metabolism, proteins and biochemicals synthesis, and detoxification, its function is vital for the homeostasis of our body. The impairment of liver function may cause dysfunction or even shut down other systems in our body. Therefore, a better understanding of the pathogenesis of the liver disorder is not only a key issue in medical science, but it may also affect the general health and diseases of other body systems in a variety of ways. Finally, causing significant public health and economic losses globally. However, the impact and interactions of liver disorders on the progression, treatments, and prognosis of other systemic disorders, or vice versa, remain largely unknown. Recent studies have demonstrated the interactions between diabetes mellitus and liver diseases, and implying a possible deteriorating effect of diabetes on liver disease progression, treatment outcomes, and hepatic carcinogenesis. These lines of evidence not only verify the need for a better understanding of the interactions between liver and other disorders, but also justify a more extensive exploration of the interactions between liver diseases and other systemic disorders.

In this study, the investigators aim to examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation. The investigators will examine the impacts of different systemic diseases on the disease progression and prognosis of Taiwanese patients with liver diseases and vice versa. Moreover, the investigators will also examine the different therapeutic strategies (including western, traditional Chinese medical, surgical or varied treatments) used for the treatments of liver diseases or systemic diseases, and their effects on the disease progression, long-term outcomes and prognosis of patients with chronic liver diseases or other systemic diseases in Taiwan.

Eligibility criteria: Inclusion Criteria:

* Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation

Exclusion Criteria:

* Age younger than 18 or older than 99 years

Primary outcomes:
measure: The incidence of a new diagnosis of hepatocellular carcinoma (HCC)
timeFrame: From the date of enrollment until the date of first documented diagnosis of HCC, assessed up to 120 months.
measure: The incidence of a new diagnosis of any event of liver cirrhosis complications
timeFrame: From the date of enrollment until the date of first documented any event of liver cirrhosis complications, or date of death from any cause, whichever came first, assessed up to 120 months.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Ching-Sheng Hsu
Study officials:
affiliation: Liver Diseases Research Center, Taipei Tzu Chi Hospital
name: Ching-Sheng Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CC, Tseng CW, Tseng KC, Chen YC, Wu TW, Chang SY, Chang YJ, Chao YC, Hsu CS. Radiofrequency ablation versus surgical resection for the treatment of solitary hepatocellular carcinoma 2 cm or smaller: A cohort study in Taiwan. J Formos Med Assoc. 2021 May;120(5):1249-1258. doi: 10.1016/j.jfma.2020.11.010. Epub 2020 Dec 4.