Open Versus Laparoscopic Ablation of Liver Malignancies (OPTIMAL)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Lucas Alexander Knøfler, MD
Data sourced from clinicaltrials.gov
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