Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Radiofrequency ablation is a cancer treatment that uses heat made by radio waves to kill cancer cells. Radiofrequency is a type of electrical energy that heats up solid tumours and kills it. The aim of this study is to compare a new method we have developed for ablating liver tumours, the hepatic "cool-wet" radiofrequency ablation system with other methods already available. The study also investigates how safe the method is to use (phase 1 of the study) and how effective a treatment it is (phase 2).

Who can participate?
Adults (aged at least 18) with liver cancer.

What does the study involve?
There are two phases to the study. In phase 1, the safety of “cool-wet” radiofrequency system is tested. In phase 2, participants are randomly allocated into one of two groups. Those in group 1 undergo a conventional hepatic (liver) ablation technique. Those in group 2 are given the new “cool-wet” hepatic radiofrequency ablation system. The clinical outcomes of the two groups of participants are then compared in terms of whether the treated cancer reoccurred.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The Hospital del Mar (Spain)

When is the study starting and how long is it expected to run for?
January 2012 to December 2017

Who is funding the study?
Health Research Fund (Fondo de Investigación Sanitaria) (Spain)

Who is the main contact?
Dr Rita Quesada

Trial website

Contact information



Primary contact

Dr Rita Quesada


Contact details

Parc de Rerceca Biomèdica de Barcelona
Doctor Aiguader
08003 Barcelona

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Treatment of primary and secondary liver tumors with an hepatic ablation cool-wet radiofrequency system: an interventional single-centre study.



Study hypothesis

1. Assess the safety of the radio-frequency ablation with the new device ("cool-wet system" to treat hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter.
2. Verify if the new radio-frequency method is at least as effective than the conventional method in terms of lower recurrence and total ablation of the lesion (single puncture). The conventional method considers the current technique performed by interventional radiologists and surgeons of the hospital (ablation method cool-tip and microwaves) for any of the possible ways of application (percutaneous, laparoscopic or open surgery).

Ethics approval

1. Ethical Committee of Clinical Research of the Hospital del Mar, 27/06/2012, ref: 2012/4776/I
2. Agencia Española del Medicamento y Producto Sanitario, 10/06/2013, ref: 438/13/EC

Study design

Interventional single-centre study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter


Radio-frequency ablation with a "Cool-wet" radio-frequency system
1. Phase I: Safety pilot study based on 20 patients. There is no control group
2. Phase II: Randomized, parallel -group single-blind study
2.1. Group 1: Conventional hepatic ablation technique (control group). The method of ablation control is based on microwaves (AMICA). It considers 55 patients
2.2. Group 2: New "cool-wet" hepatic radio-frequency ablation system previously described in Phase I. 55 patients

Intervention type



Drug names

Primary outcome measure

1. HLR (Hepatic local recurrence): Characterized by a partial response (PR) or disease progression (DP) of the treated target lesion according to RECIST 1.1 VA. in the abdominal CT or MRI at 6 months (maximum tolerance 50 days) and then every 6 months until 5 years. The maximum cutting thickness to evaluated this is 5 mm
2. MDA (Minimum Diamater Ablation): Defined as the smallest diameter of a single ablation measured by an abdominal CT or MRI at 6-months of the procedure. When they have been treated more than one target lesion, the smallest diameter will be considered

Secondary outcome measures

1. Maximum diameter of the ablation (anteroposterior, transverse and craniocaudal)
2. Mean volume of the ablation, measured by digital reconstruction from CT or MRI after a month of PO using appropriate image software

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Nodules suggestive of HCC or liver metastases from any source as abdominal CT, MRI or biopsy. The initial imaging test (CT or MRI) must not be older than 30 days (50 days maximum tolerance).
2. Considered unresectable hepatic nodules in multidisciplinary and capable local treatment session
3. Number of nodes: between 1 and 3
4. Size of the nodules: between 1.5 and 4 cm
5. Percutaneous, laparoscopic or open surgical access.
6. Signature of informed consent
7. Aged at least 18

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Higher than third level of Anesthetic risk measured by the classification of the American Association anesthesia (ASA IV)
2. Carrier of a cardiac pacemaker
3. Thrombocytopenia <50,000 / mL
4. Suspicion of thrombosis portal by presence of tumor
5. Child C and grading of hepatic failure
6. Previous biliodigestive anatomosis
7. Hepatic subcapsular nodule

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital del Mar

Sponsor information


Parc de Salut Mar- Hospital del Mar

Sponsor details

Passeig Marítim 25-29

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Health Research Fund (Fondo de Investigación Sanitaria) (FIS PI12/00799)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The trialists intend to publish at least two papers, one after the first Phase I and another after Phase II. They have already finished the first Phase of the study and are currently analyzing the results. They plan to publish these as soon as they have them. The second publication will depend on the inclusion of patients.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/06/2018: An intention to publish date has been added. 04/06/2018: The following changes have been made: 1. The recruitment end date was changed from 12/05/2018 to 01/06/2020. 2. The overall trial end date was changed from 31/12/2019 to 31/12/2021. 07/03/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/12/2015 to 12/05/2018. 2. The overall trial end date was changed from 01/12/2017 to 31/12/2019.