Treatment of primary and secondary liver tumors with an hepatic ablation cool-wet radiofrequency system.
| ISRCTN | ISRCTN73194360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73194360 |
| Secondary identifying numbers | 438/13/EC |
- Submission date
- 13/04/2015
- Registration date
- 14/06/2015
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 (hepatocellular carcinoma and macrotrabecular with <3 lesions of 1.5-4 cm diameter)
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 June 2020
Who is funding the study?
Health Research Fund (Fondo de Investigación Sanitaria) (Spain)
Who is the main contact?
Dr Rita Quesada
rquesada@imim.es
Contact information
Public
Parc de Rerceca Biomèdica de Barcelona
Doctor Aiguader, 88
08003 Barcelona
Barcelona
08003
Spain
| Phone | 93 316 16 21 |
|---|---|
| rquesada@imim.es |
Study information
| Study design | Interventional prospective randomized parallel-group single-blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Treatment of primary and secondary liver tumors with an hepatic ablation cool-wet radiofrequency system: an interventional single-centre study. |
| Study acronym | GNOMON |
| Study hypothesis | Current study hypothesis as of 17/06/2020: 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 technical success of the lesion and overall survival. The conventional method considers the current technique performed by interventional radiologists and surgeons of the hospital (microwaves) for any of the possible ways of application (percutaneous, laparoscopic or open surgery). Previous 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(s) | 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 |
| Condition | Hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter |
| Intervention | Current interventions as of 15/06/2020: Radio-frequency ablation with a "Cool-wet" radio-frequency system Phase II: Randomized, parallel-group single-blind study 1. Group MWA: Conventional hepatic ablation technique (control group). The method of ablation control is based on microwaves (AMICA) (n=41 patients) 2. Group RFA: New "cool-wet" hepatic radio-frequency ablation system . (n=41 patients) Previous interventions: 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 | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measures as of 15/06/2020: 1. Technical success evaluated as a complete tumor coverage by the ablation zone at 1-month follow-up 2. Local tumour progression after 2 years of follow-up, measured as complete tumor coverage by the ablation zone and the appearance of any tumor focus in contact with ablation zone after 2-years follow-up Previous primary outcome measures: 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 Diameter 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 | Current secondary outcome measures as of 17/06/2020: 1. Safety: all treatment-related complications classified according to the Society of Interventional Radiology guidelines by treated tumor basis taking into account the highest grade. Complications recorded during the total follow-up of the patients. 2. Overall survival (OS) measured as the mean survival expressed in months per each group of treatment 3. Short to long diameter ratio (SLR) of the ablation measured from the TAC performed 1 month after the ablation 4. Sphericity ratio (SR) measured as the largest diameter to average of the two remaining diameters of the ablation zone. Ratio close to 1 implies more spherical shape, measured from the TAC performed 1 month after the ablation. 5. Surface area of the coagulation zone measured in cm² from the reconstruction of the coagulation zone (1 month after the ablation) 6. Coefficient of variation (CV) as a measure for reproducibility expressed in % and measured from the reconstruction of the coagulation zone (1 month after the ablation) Previous 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 study start date | 01/01/2012 |
| Overall study end date | 01/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 102 |
| 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 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 | 01/06/2015 |
| Recruitment end date | 01/04/2020 |
Locations
Countries of recruitment
- Spain
Study participating centre
Spain
Sponsor information
Hospital/treatment centre
Passeig Marítim 25-29
Barcelona
08003
Spain
| Phone | 93 248 32 44 |
|---|---|
| fburdio@hotmail.com | |
"ROR" |
https://ror.org/03a8gac78 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Dr Rita Quesada (rquesada@imim.es). Part of the database will become available for 2 years to medical researchers. The principal investigator of the study will evaluate the request and will decide which data can be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/01/2022 | 10/07/2023 | Yes | No |
Editorial Notes
10/07/2023: Publication reference added.
17/06/2020: The following changes were made to the trial record:
1. The total final enrolment number and IPD sharing statement were added.
2. The secondary outcome measures and study hypothesis were updated.
3. The recruitment end date was changed from 01/06/2020 to 01/04/2020.
4. The overall trial end date was changed from 31/12/2021 to 01/06/2020.
5. The intention to publish date was changed from 31/12/2018 to 30/06/2020.
15/06/2020: The following changes were made to the trial record:
1. The study design was changed from 'Interventional single-centre study' to 'Interventional prospective randomized parallel-group single-blinded study'.
2. The interventions and primary and secondary outcome measures were updated.
3. The recruitment start date was changed from 01/01/2013 to 01/06/2015.
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.
