Open Versus Laparoscopic Ablation of Liver Malignancies

Hepatocellular Carcinoma Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304766
• Other study ID #: H-23015954
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: Lucas Alexander Knøfler, MD
• Phone: +4520114529
• Email: lucas.alexander.knoefler[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Liver Metastases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications measured by the comprehensive complication index.	Comprehensive Complication Index (CCI) scores compared between open and laparoscopic ablation groups. A higher CCI score represents a larger complication burden.	Complications are registered and clavien-dindo graded 30 days after surgery.
Secondary	Tumor ablation completeness.	Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT.	30 days after surgery.
Secondary	Quality of Recovery score (QoR)	Questionnaires are filled out prior to surgery and after	Before surgery and postoperative day 1, 7 and 30.
Secondary	Quality of Life score (QoL)	Questionnaires are filled out prior to surgery and after	Before surgery and on postoperative day 30.
Secondary	Overall survival	Overall and disease-free survival measured as survival status 90 days after surgery.	Up to 90 days after surgery