Open Versus Laparoscopic Ablation of Liver Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hepatocellular Carcinoma Cholangiocarcinoma Liver Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open ablation

Laparotomy performed for open ablation of the tumor

Group Type ACTIVE_COMPARATOR

Open ablation

Intervention Type PROCEDURE

Heat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.

Laparoscopic ablation

Ablation of the tumor performed by laparoscopic approach

Group Type EXPERIMENTAL

Laparoscopic ablation

Intervention Type PROCEDURE

Heat-based ablation modality performed by laparoscopy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.