Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523608
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prediction of Decompensation and HCC Development in Patients with Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT
Brief Summary:
The aim of this observational study is to predict the short- and long-term development of acute severe disease events de novo hepatocarcinoma HCC and mortality in patients with advanced chronic liver disease using the M10S20 Liver stiffness and Model for End-Stage Liver Disease Score MELD combined and PLEASE Platelet Etiology Age Sex und Elastography scores as well as the validation of the cost-effectiveness of the algorithm
Patients in this study are randomly divided into two groups
Control group patients are examined according to the current clinical standard protocol biannual follow-up
Stratified surveillance program
High-risk patients will receive an appointment for a hospital visit every 3 months
Low-risk patients could receive an appointment in one year When necessary if decompensation develops or HCC occurs patients could be followed-up more frequently
Patients in this study are randomly divided into two groups
Control group patients are examined according to the current clinical standard protocol biannual follow-up
Stratified surveillance program
High-risk patients will receive an appointment for a hospital visit every 3 months
Low-risk patients could receive an appointment in one year When necessary if decompensation develops or HCC occurs patients could be followed-up more frequently
Detailed Description:
Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups
Patients in the control group are examined according to the current clinical standard protocol biannual follow-up or more frequently when decompensation or HCC develops
Patients in the study group will be stratified for the risk of decompensationmortality and de novo-HCC-risk based on the M10S20 Liver stiffness and MELD combined and PLEASE Platelet Etiology Age Sex und Elastography scores
High-risk patients will be allocated for a further computer tomography CT or magnetic resonance imaging MRI examination and an alpha-fetoprotein AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months
Low-risk patients could receive an appointment in one year Patients in both arms either outpatient or inpatient will undergo at each visit an ultrasound examination with liver stiffness measurement and a routine blood test Other examinations will be carried out according to standard medical care Blood urine and stool tests as well as instrumental diagnostics such as duplex ultrasound CT MRI endoscopies bone marrow punctures elastographies transjugular intrahepatic portosystemic shunt TIPS implantations operations etc will be performed as part of the usual diagnostic clarification
Hepatic encephalopathy is a decompensation event that will be diagnosed based on the West-Haven criteria the number-connection test the flicker frequency analysis and electroencephalogram Written consent is required for every admitted patient Data protection concept When a patient is enrolled in the study a center-specific study ID is first assigned for the purpose of pseudonymization
The data collected is documented in an Excel spreadsheet The assignment of the center-specific study ID to the respective patient is only possible for the respective investigator Prof Dr Trebicka and his staff study nurse For statistical evaluations an analysis-specific data table will be created which can be processed with an appropriate statistics program
Patients cannot be identified with the data collected and the scientific research that derives from it
Patients in the control group are examined according to the current clinical standard protocol biannual follow-up or more frequently when decompensation or HCC develops
Patients in the study group will be stratified for the risk of decompensationmortality and de novo-HCC-risk based on the M10S20 Liver stiffness and MELD combined and PLEASE Platelet Etiology Age Sex und Elastography scores
High-risk patients will be allocated for a further computer tomography CT or magnetic resonance imaging MRI examination and an alpha-fetoprotein AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months
Low-risk patients could receive an appointment in one year Patients in both arms either outpatient or inpatient will undergo at each visit an ultrasound examination with liver stiffness measurement and a routine blood test Other examinations will be carried out according to standard medical care Blood urine and stool tests as well as instrumental diagnostics such as duplex ultrasound CT MRI endoscopies bone marrow punctures elastographies transjugular intrahepatic portosystemic shunt TIPS implantations operations etc will be performed as part of the usual diagnostic clarification
Hepatic encephalopathy is a decompensation event that will be diagnosed based on the West-Haven criteria the number-connection test the flicker frequency analysis and electroencephalogram Written consent is required for every admitted patient Data protection concept When a patient is enrolled in the study a center-specific study ID is first assigned for the purpose of pseudonymization
The data collected is documented in an Excel spreadsheet The assignment of the center-specific study ID to the respective patient is only possible for the respective investigator Prof Dr Trebicka and his staff study nurse For statistical evaluations an analysis-specific data table will be created which can be processed with an appropriate statistics program
Patients cannot be identified with the data collected and the scientific research that derives from it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None