Open Versus Laparoscopic Ablation of Liver Malignancies

Not Applicable

Recruiting

• Conditions: Liver Metastases; Hepatocellular Carcinoma; Cholangiocarcinoma
• Interventions: Procedure: Open ablation; Procedure: Laparoscopic ablation

• Registration Number: NCT06304766
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study First Submitted: 2023-10-09
• Study Start: 2023-12-15
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open ablation	Open ablation	Laparotomy performed for open ablation of the tumor
Laparoscopic ablation	Laparoscopic ablation	Ablation of the tumor performed by laparoscopic approach

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life score (QoL)	Before surgery and on postoperative day 30.	Questionnaires are filled out prior to surgery and after
Quality of Recovery score (QoR)	Before surgery and postoperative day 1, 7 and 30.	Questionnaires are filled out prior to surgery and after
Tumor ablation completeness.	30 days after surgery.	Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT.
Overall survival	Up to 90 days after surgery	Overall and disease-free survival measured as survival status 90 days after surgery.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark