肝悪性腫瘍に対する開腹手術対腹腔鏡下アブレーション - ランダム化臨床試験プロトコル
Lucas Alexander Knøfler1,2,3, Jeanett Klubien1,2,3, Peter Nørgaard Larsen1
1Department of Digestive Diseases, Transplantation and General Surgery, Copenhagen University Hospital - Rigshospitalet.
Introduction:
Heat-based ablation has emerged as a less invasive alternative to surgical resection for primary and metastatic liver cancer. However, when a percutaneous approach is not feasible, ablation during open surgery is often performed. Open surgery may be accompanied by an increased risk of complications, especially in patients with comorbidities or liver cirrhosis. Laparoscopic ablation may reduce morbidity while offering a similar efficacy; however, even so, no randomised studies have been conducted.
Methods:
Eighty adult patients at a high-volume hepatobiliary centre will be randomised 1:1 to either open or laparoscopic ablation. Eligible participants have at least one liver tumour amenable to ablation but unsuitable for a percutaneous approach. The primary endpoint is the rate of complications (Clavien-Dindo ≥ 2) within 30 days after surgery. Secondary outcomes include ablation success, length of stay, post-operative pain, quality of life and recovery and 90-day mortality.
Conclusions:
This trial will provide the first randomised comparison of laparoscopic and open ablation for liver tumours that are not amenable to percutaneous ablation. We hypothesise that laparoscopic ablation can reduce post-operative complication rates while maintaining comparable efficacy, potentially establishing a new standard of care for selected patients.
Funding:
LAK and HCP have received unrestricted research grants from the Danish Cancer Society, Independent Research Fund Denmark, The Danish Health Authority and the Research Council of Copenhagen University Hospital - Rigshospitalet.
Clinicaltrials Id:
NCT06304766.
