Ablation of Hepatocellular Carcinoma: a Nationwide Study

NCT05498779 | Completed

• 1 other identifier: -A10492
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

Background Hepatocellular carcinoma (HCC) is the most common primary malignancy in the liver. Chronic infection with hepatitis C virus (HCV) is a significant risk factor and may be associated with inferior outcome. According to the Danish national guidelines, ablation should be offered patients with early HCC (tumor \< 3 cm) in a cirrhotic liver, who are not transplant candidates. However, the effect of size of the HCC tumor and Hepatitis C virus (HCV) as etiology are insufficiently investigated. Purposes

1. 1.Investigate association between HCC tumor size and survival and recurrence after ablation.
2. 2.Investigate survival and recurrence after ablation in patients with HCV-related HCC compared with HCC due to other etiologies.

Conditions

Hepatocellular Carcinoma; Ablation; Hepatitis C

Keywords

Radiofrequency ablation; RFA; Microwave ablation; MW; HCC; HCV

Outcome Measures

Primary Outcomes (2)

• Overall survival related to tumor size

  Overall survival will be estimated by Kaplan-Meier methods with log-rank tests, and Cox proportional hazards regression model

  January 2013 through August 2022

• Recurrence after ablation

  Recurrence by Aalen-Johansen estimator and Fine-Gray proportional subhazards model, death and transplantation as competing risks

  January 2013 through August 2022

Secondary Outcomes (1)

• Overall survival related to HCV virus

  January 2013 through August 2022

Study Arms (1)

Non-resectable hepatocellular carcinoma

Patients treated with ablation therapy as first treatment for non-resectable hepatocellular carcinoma.

Procedure: Ablation therapy

Interventions

Ablation therapy PROCEDURE

Radiofrequency or microwave ablation

Non-resectable hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with hepatocellular carcinoma treated with ablation therapy as first treatment and no prior hepatic surgery.

You may qualify if:

• Hepatocellular carcinoma
• Age \> 18 years
• Ablation as the first surgical treatment for HCC

You may not qualify if:

• Hepatic resection or transplantation prior to ablation
• Ablation performed in conjunction with resection
• Ablation for recurrence of HCC

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Study Officials

• Hans-Christian Pommergaard, MD, ph.d.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.med., ph.d., clinical associate professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

DK (1)