Ablation of Hepatocellular Carcinoma: a Nationwide Study
NCT ID: NCT05498779
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
490 participants
OBSERVATIONAL
2022-06-01
2023-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purposes
1. Investigate association between HCC tumor size and survival and recurrence after ablation.
2. Investigate survival and recurrence after ablation in patients with HCV-related HCC compared with HCC due to other etiologies.
Methods This study is based on data from the Danish Liver and Bile Duct Cancer Database (DLGCD) and the Danish Database for Hepatitis B and C (DANHEP) and the laboratory database (DANVIR), which collectively include information on patient characteristics, tumor characteristic, laboratory results, and information regarding ablation, HCV status, and antiviral treatment, respectively.
Perspectives Ablation has been widely used for decades, but studies investigating the effect of ablation for HCC in patients with HCV and size of HCC are lacking. This study will contribute considerably to the level of evidence and may impact both Danish and international guidelines for HCC treatment.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Three nationwide databases and medical records will be used to address these important knowledge gaps. First, the association between survival and recurrence after ablation and HCC tumor size will be investigated. Second, the survival and recurrence after ablation in patients with HCC related to HCV will be investigated. due to HCV is different from that in patients with HCC due to other reasons than HCV. The nationwide data in these databases will reflect general clinical practice in an unselected population and provide novel information.
Purpose
With data from the Danish Liver and Bile Duct Cancer Database (DLGCD), the Danish Database for Hepatitis B and C (DANHEP), the National hepatitis laboratory database (DANVIR), and medical records, prognostic factors for survival in a large cohort of patients with HCC treated with ablation therapy will be investigated with the following aims:
1. Investigate association between HCC tumor size and survival and recurrence after ablation therapy.
2. Investigate survival and recurrence after ablation therapy in patients with HCV-related HCC compared with HCC due to other etiologies.
Hypotheses
1. Survival and recurrence after ablation is lower in patients with large HCC tumors than in patients with small tumors. However, the cut-off in current Danish guidelines is too conservative.
2. The survival after ablation is lower in patients with HCC due to HCV than in patient with HCC due to other reasons.
Methods This study is based on data from three large, nationwide databases in Denmark. DLGCD is an ongoing prospective nationwide database for patients treated for HCC, cholangiocarcinoma, colorectal liver metastases, or non-colorectal liver metastases. The database was established in 2012 and started collecting data in 2013. So far, data from the DLGCD have not been published. To date, the database includes data on 5056 surgical procedures in 2975 patients with HCC. To study the effect of etiology on survival and recurrence after treatment for HCC, data from the DANHEP and DANVIR databases will be incorporated. The three databases can be linked together as they all use CPR number to identify patients. DLGCD does not contain any information on HCV. However, DANHEP and DANVIR are nationwide databases that contain detailed information on individuals with chronic viral hepatitis in Denmark. DANHEP is a database with ongoing prospective registration of adult patients treated at a hospital (outpatient or inpatient) with chronic viral hepatitis B or C, established in 2002. DANVIR is a laboratory database containing information about HCV test (bot positive and negative) since 1991. The observation period of the study will be from 2013 to 2022. With data from the DANHEP and DANVIR databases, patients with HCC that have been infected with HCV can be identified to study the effect of ablation in HCV-infected patients versus patients without HCV infection.
Statistics The dataset will be described with frequencies and percentages for categorical variables and means or medians for continuous variables. For investigating differences, Student's t -test or Mann-Whitney U for continuous data and Pearson chi2 or Fisher's exact tests for categorical data will be used as appropriate. To determine risk factors affecting prognosis, recurrence and survival outcomes after ablation, Cox proportional hazard regression model will be used to calculate hazard ratios with 95% confidence intervals in both univariable and multivariable analyses. The multivariable analysis will be adjusted for age, sex, number of tumor, size of largest tumor, HCV-status, HBV-status, and Child-Pugh score. In addition, survival will be estimated by Kaplan-Meier methods with log-rank tests for HCV vs. non-HCV groups. It is possible that some patients with HCC never had a test for HCV. In a sensitivity analysis, only patients with HCC that had a HCV test (positive or negative) will be included. For recurrence we will use Fine-Gray proportional subhazards model and Aalen-Johansen estimator with death and transplantation as competing risks. The level of statistical significance will be set to p\<0.05. All statistical analyses will be performed using R, version 4.0.3.
Perspectives With data from nationwide databases, the aim is to investigate survival and recurrence for HCC and the significance of tumor size and etiology of HCC in a large group of patients. Ablation has been widely used for decades, but the majority of published studies within this area are from Asia and based on small cohorts of highly selected patients. Furthermore, to our knowledge, no previous larger studies have determined the effect of ablation in patients with HCV-related HCC. Evidence will be improved with a large, Danish cohort reflecting outcomes in general clinical practice in unselected patients. The study has potential to contribute to the future guidelines regarding indication for ablation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-resectable hepatocellular carcinoma
Patients treated with ablation therapy as first treatment for non-resectable hepatocellular carcinoma.
Ablation therapy
Radiofrequency or microwave ablation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ablation therapy
Radiofrequency or microwave ablation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \> 18 years
* Ablation as the first surgical treatment for HCC
Exclusion Criteria
* Ablation performed in conjunction with resection
* Ablation for recurrence of HCC
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hans-Christian Pommergaard
Cand.med., ph.d., clinical associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hans-Christian Pommergaard, MD, ph.d.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rigshospitalet
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
-A10492
Identifier Type: -
Identifier Source: org_study_id