AI-ACLD Study: Artificial Intelligence in Advanced Chronic Liver Disease.
Summary description of the study
The research project studies the possibility of using an artificial intelligence-based system in patients with advanced chronic liver disease (liver cirrhosis) to record variations in a patient's health status, with the aim of early identification of clinical improvement or deterioration. We want to know if the use of this system, which is based on the recording and processing of various clinical parameters using an Apple Watch, can correlate with the clinical evolution of the patient and ultimately be able to improve care management and quality of life.
(BASEC)
Intervention under investigation
we will use an Apple Watch to specifically monitor patients with liver cirrhosis, who will wear it for the period specified by the study. Patients hospitalized for a complication of cirrhosis will then be continuously monitored with the Apple Watch from the time of admission until discharge. During part B of the study, for which a separate informed consent document is provided, patients with cirrhosis followed in an outpatient setting will be included, who will be continuously monitored with the Apple Watch for a total of 6 months. The patient included in part A of the study may, if desired, continue their participation in part B of the study from the time of discharge for the following 6 months.
(BASEC)
Disease under investigation
advanced chronic liver disease (liver cirrhosis)
(BASEC)
Inclusion criteria, part A: all patients aged between 18 and 75 years with ACLD hospitalized at the Cantonal Hospital (EOC) of Lugano or Bellinzona, Switzerland for symptoms of hepatic decompensation or acute or chronic liver failure. These include ascites, hepatorenal syndrome, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding, or jaundice. Inclusion criteria, part B: all patients aged between 18 and 75 years with ACLD and Child-Pugh B cirrhosis followed at our Department of Gastroenterology and Hepatology, Cantonal Hospital will be evaluated for inclusion in the study. (BASEC)
Exclusion criteria
Exclusion criteria, part A: patients who are unable or refuse to give written informed consent; patients who are unable to wear and/or properly use the device; patients with hepatocellular carcinoma beyond the Milan criteria (a lesion up to 5 cm or 3 lesions up to 3 cm in diameter). Exclusion criteria, part B: patients who are unable or refuse to give written informed consent; patients who are unable to wear and/or properly use the device; presence of any decompensation or ACLF. (BASEC)
Trial sites
Bellinzona, Lugano
(BASEC)
Sponsor
Ospedale Regionale di Lugano
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Andrea De Gottardi
+4191 811 76 36
Andrea.DeGottardi@cluttereoc.chServizio di Gastroenterologia ed Epatologia Ospedale Regionale di Lugano
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Ticino
(BASEC)
Date of authorisation
29.08.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Application of artificial intelligence using wearable technology in patients with advanced chronic liver disease (ACLD): a trajectomics approach. (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available