Laparoscopic Versus Open Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Complications measured by the comprehensive complication index.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Open ablation
Laparotomy performed for open ablation of the tumor
Intervention: Open ablation (Procedure)
Laparoscopic ablation
Ablation of the tumor performed by laparoscopic approach
Intervention: Laparoscopic ablation (Procedure)
Outcomes
Primary Outcomes
Complications measured by the comprehensive complication index.
Time Frame: 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 Outcomes
- Quality of Recovery score (QoR)(Before surgery and postoperative day 1, 7 and 30.)
- Tumor ablation completeness.(30 days after surgery.)
- Quality of Life score (QoL)(Before surgery and on postoperative day 30.)
- Overall survival(Up to 90 days after surgery)
Investigators
Hans-Christian Pommergaard
MD, DMSc, PhD, Clinical Research Associate Professor
Rigshospitalet, Denmark