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Trial Title:
Open Versus Laparoscopic Ablation of Liver Malignancies
NCT ID:
NCT06304766
Condition:
Hepatocellular Carcinoma
Cholangiocarcinoma
Liver Metastases
Conditions: Official terms:
Cholangiocarcinoma
Conditions: Keywords:
Laparoscopic ablation
Open ablation
Complications
Ablation response
Quality of life
Randomized
Multicenter
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation
after operability assesment.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic ablation
Description:
Heat-based ablation modality performed by laparoscopy. Centers may use either
radiofrequency or microwave ablation. The modality should be the same in both groups.
Arm group label:
Laparoscopic ablation
Intervention type:
Procedure
Intervention name:
Open ablation
Description:
Heat-based ablation modality performed by laparotomy. Centers may use either
radiofrequency or microwave ablation. The modality should be the same in both groups.
Arm group label:
Open ablation
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Hans-Christian Pommergaard, MD DMSc PhD
Email:
hans-christian.pommergaard@regionh.dk
Start date:
December 15, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304766
