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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06304766
Other study ID # H-23015954
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2023
Est. completion date December 2025

Study information

Verified date March 2024
Source Rigshospitalet, Denmark
Contact Lucas Alexander Knøfler, MD
Phone +4520114529
Email lucas.alexander.knoefler@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.


Description:

Liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. Patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. Ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. Ablation during open surgery has a high potential of complications. Laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. This study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - One or more tumors not amenable to percutaneous ablation, age = 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment. Exclusion Criteria: - Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.

Study Design


Intervention

Procedure:
Laparoscopic ablation
Heat-based ablation modality performed by laparoscopy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.
Open ablation
Heat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complications measured by the comprehensive complication index. Comprehensive Complication Index (CCI) scores compared between open and laparoscopic ablation groups. A higher CCI score represents a larger complication burden. Complications are registered and clavien-dindo graded 30 days after surgery.
Secondary Tumor ablation completeness. Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT. 30 days after surgery.
Secondary Quality of Recovery score (QoR) Questionnaires are filled out prior to surgery and after Before surgery and postoperative day 1, 7 and 30.
Secondary Quality of Life score (QoL) Questionnaires are filled out prior to surgery and after Before surgery and on postoperative day 30.
Secondary Overall survival Overall and disease-free survival measured as survival status 90 days after surgery. Up to 90 days after surgery
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