Open Versus Laparoscopic Ablation of Liver Malignancies (OPTIMAL)

March 11, 2024 updated by: Hans-Christian Pommergaard, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open ablation
Laparotomy performed for open ablation of the tumor
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.
Experimental: Laparoscopic ablation
Ablation of the tumor performed by laparoscopic approach
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Complications are registered and clavien-dindo graded 30 days after surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hans-Christian Pommergaard, MD DMSc PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23015954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Open ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe