NCT06304766

Open Versus Laparoscopic Ablation of Liver Malignancies

Laparoscopic Versus Open Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Cholangiocarcinoma
• Liver Metastases

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic 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.
PROCEDURE	Open 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.

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-03-12
• Last updated: 2024-03-13

Locations

1 site across 1 country: Denmark