Liver DiseaseNCT06980571
Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections
A study testing radiofrequency ablation in people with Liver Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether a particular method of operating on the liver is superior to the "gold" standard commonest technique. CUSA (ultrasonic agitation) will be compared to the newer heat coagulation technique (radiofrequency ablation) and comparisons of blood loss, transfusion requirements… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Disease
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Dec 2008
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any adult patient listed for liver resection giving informed consent
Who cannot join
- children, non-consent and diminished responsibility
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a particular method of operating on the liver is superior to the "gold" standard commonest technique. CUSA (ultrasonic agitation) will be compared to the newer heat coagulation technique (radiofrequency ablation) and comparisons of blood loss, transfusion requirements, complication rates, hospital stay, effect on liver function, health economics and death rate will be made. The groups will be assessed for comparability in terms of underlying disease, resection type, underlying concurrent illnesses, sex, age, background liver disease. Standardisations of the rest of the operation will be carried out including anaesthetic technique and fluid requirements will be assessed by oesophageal Doppler. 100 patients will be recruited.
- Conditions
- Liver Disease
- Being tested
- radiofrequency ablation
- Keywords
- liver resection, blood loss, resection technique, CUSA, radiofrequency ablation, health economics, benign and malignant liver disease
- Medical subject headings
- Liver Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationDevice
FDA approved intervention being compared with gold standard (most common intervention)
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Active comparator | 50 patients randomised to radiofrequency ablation technique of liver resection Receives: Device: radiofrequency ablation |
| CUSA | No intervention | 50 patients having liver resection randomised to CUSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss per cm squared of liver parenchyma cut through
Measured: operation date until three months from discharge
Secondary outcomes (1)
mortality
incidence of post-operative complications measured over a thirty day period
Measured: inpatient and thirty day mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study startJun 2006
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert R Hutchins, MB BS MS FRCS, Principal investigator, Royal London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980571
- Sponsor's protocol ID
- P3/04/Q0605/31
- Status last verified
- May 2025
- First submitted
- 27 Jan 2009
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections
- ClinicalTrials.gov ID
- NCT06980571
- Acronym / sponsor ID
- P3/04/Q0605/31
- Conditions
- Liver Disease
- Keywords
- liver resection, blood loss, resection technique, CUSA, radiofrequency ablation, health economics, benign and malignant liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 May 2025 (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 determine whether a particular method of operating on the liver is superior to the "gold" standard commonest technique. CUSA (ultrasonic agitation) will be compared to the newer heat coagulation technique (radiofrequency ablation) and comparisons of blood loss, transfusion requirements, complication rates, hospital stay, effect on liver function, health economics and death rate will be made. The groups will be assessed for comparability in terms of underlying disease, resection type, underlying concurrent illnesses, sex, age, background liver disease. Standardisations of the rest of the operation will be carried out including anaesthetic technique and fluid requirements will be assessed by oesophageal Doppler. 100 patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Active comparator | Device: radiofrequency ablation50 patients randomised to radiofrequency ablation technique of liver resection |
| CUSA | No intervention | –50 patients having liver resection randomised to CUSA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any adult patient listed for liver resection giving informed consent
Key exclusion criteria (1 listed)
- children, non-consent and diminished responsibility
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 |
|---|---|---|
| radiofrequency ablationFDA approved intervention being compared with gold standard (most common intervention) | Device | Radiofrequency ablation |
Primary outcome
Blood loss per cm squared of liver parenchyma cut through
Time frame: operation date until three months from discharge
1 secondary outcome
mortality
Time frame: inpatient and thirty day mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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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.
Robert R Hutchins, MB BS MS FRCS principal investigator
Royal London Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation in people with Liver Disease, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 20 May 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss per cm squared of liver parenchyma cut through (time frame: operation date until three months from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.