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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Heat-based ablation modality performed by laparoscopy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.
Heat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.
Rigshospitalet
Copenhagen, Denmark
RECRUITINGComplications 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.
Time frame: Complications are registered and clavien-dindo graded 30 days after surgery.
Tumor ablation completeness.
Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT.
Time frame: 30 days after surgery.
Quality of Recovery score (QoR)
Questionnaires are filled out prior to surgery and after
Time frame: Before surgery and postoperative day 1, 7 and 30.
Quality of Life score (QoL)
Questionnaires are filled out prior to surgery and after
Time frame: Before surgery and on postoperative day 30.
Overall survival
Overall and disease-free survival measured as survival status 90 days after surgery.
Time frame: Up to 90 days after surgery
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