Hepatocellular CarcinomaOPTIMALNCT06304766
Open Versus Laparoscopic Ablation of Liver Malignancies
A study testing Laparoscopic ablation and Open ablation in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Liver Metastases
- What is being tested?
- Laparoscopic ablation and Open ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Hans-Christian Pommergaard, MD DMSc PhD, hans-christian.pommergaard@regionh.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- Laparoscopic ablation, Open ablation
- Keywords
- Laparoscopic ablation, Open ablation, Complications, Ablation response, Quality of life, Randomized, Multicenter
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ablationProcedure or surgery
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 ablationProcedure or surgery
Heat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Open ablation | Active comparator | Laparotomy performed for open ablation of the tumor Receives: Procedure: Open ablation |
| Laparoscopic ablation | Experimental | Ablation of the tumor performed by laparoscopic approach Receives: Procedure: Laparoscopic ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Complications are registered and clavien-dindo graded 30 days after surgery.
Secondary outcomes (4)
Tumor ablation completeness.
Presence of tumor remnants in ablation cavity one month after procedure evaluated with contrast enhanced CT.
Measured: 30 days after surgery.
Quality of Recovery score (QoR)
Questionnaires are filled out prior to surgery and after
Measured: Before surgery and postoperative day 1, 7 and 30.
Quality of Life score (QoL)
Questionnaires are filled out prior to surgery and after
Measured: Before surgery and on postoperative day 30.
Overall survival
Overall and disease-free survival measured as survival status 90 days after surgery.
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans-Christian Pommergaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hans-Christian Pommergaard, MD DMSc PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304766
- Sponsor's protocol ID
- H-23015954
- Acronym
- OPTIMAL
- Status last verified
- Mar 2024
- First submitted
- 9 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knofler LA, Klubien J, Larsen PN, Kiim KS, Fukumori D, Tschuor C, Nielsen SD, Pommergaard HC. Open versus laparoscopic ablation of liver malignancies - a protocol for a randomised clinical trial. Dan Med J. 2026 Jan 14;73(2):A04250305. doi: 10.61409/A04250305.
PubMed 41736646
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT06304766
- Acronym / sponsor ID
- OPTIMAL / H-23015954
- Keywords
- Laparoscopic ablation, Open ablation, Complications, Ablation response, Quality of life, Randomized, Multicenter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment.
| Arm | Type | Receives |
|---|---|---|
| Open ablation | Active comparator | Procedure: Open ablationLaparotomy performed for open ablation of the tumor |
| Laparoscopic ablation | Experimental | Procedure: Laparoscopic ablationAblation of the tumor performed by laparoscopic approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic ablationHeat-based ablation modality performed by laparoscopy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups. | Procedure or surgery | Laparoscopic ablation |
| Open ablationHeat-based ablation modality performed by laparotomy. Centers may use either radiofrequency or microwave ablation. The modality should be the same in both groups. | Procedure or surgery | Open ablation |
Primary outcome
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.
4 secondary outcomes
Tumor ablation completeness.
Time frame: 30 days after surgery.
Quality of Recovery score (QoR)
Time frame: Before surgery and postoperative day 1, 7 and 30.
Quality of Life score (QoL)
Time frame: Before surgery and on postoperative day 30.
Overall survival
Time frame: Up to 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 41736646Knofler LA, Klubien J, Larsen PN, Kiim KS, Fukumori D, Tschuor C, Nielsen SD, Pommergaard HC. Open versus laparoscopic ablation of liver malignancies - a protocol for a randomised clinical trial. Dan Med J. 2026 Jan 14;73(2):A04250305. doi: 10.61409/A04250305.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Christian Pommergaard, MD DMSc PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ablation and Open ablation in people with Hepatocellular Carcinoma and Cholangiocarcinoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Alexander Knøfler, MD (+4520114529, lucas.alexander.knoefler@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications measured by the comprehensive complication index. (time frame: Complications are registered and clavien-dindo graded 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.