Cholangiocarcinoma, Hepatocellular Carcinoma, Liver Metastases
Conditions
Keywords
Laparoscopic ablation, Open ablation, Complications, Ablation response, Quality of life, Randomized, Multicenter
Brief 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.
Interventions
PROCEDURELaparoscopic 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.
PROCEDUREOpen 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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications measured by the comprehensive complication index. | Complications are registered and clavien-dindo graded 30 days after surgery. | Comprehensive Complication Index (CCI) scores compared between open and laparoscopic ablation groups. A higher CCI score represents a larger complication burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor ablation completeness. | 30 days after surgery. | Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT. |
| Quality of Recovery score (QoR) | Before surgery and postoperative day 1, 7 and 30. | Questionnaires are filled out prior to surgery and after |
| Quality of Life score (QoL) | Before surgery and on postoperative day 30. | Questionnaires are filled out prior to surgery and after |
| Overall survival | Up to 90 days after surgery | Overall and disease-free survival measured as survival status 90 days after surgery. |
Countries
Denmark
Contacts
Primary ContactLucas Alexander Knøfler, MD
Outcome results
None listed