Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.

Percutaneous Laser Ablation

Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation

Percutaneous Radiofrequency Ablation

Roberto Cianni

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.

Nodular thyroid disease is a common clinical problem whose prevalence increases with age and with a more widespread use of thyroid ultrasonography. Although most thyroid nodules are benign and need only periodic monitoring, some may require treatment for associated pressure and/or cosmetic symptoms. Although thyroid surgery is the main therapeutic approach for compressive thyroid nodules, it may be associated with several drawbacks. Long-term levothyroxine suppression treatment in elderly patients with large nodular goiters is unsatisfactory because it is ineffective. Furthermore, it is associated with adverse effects on bones and the cardiovascular system. Nonsurgical, minimally invasive treatment modalities such as percutaneous laser ablation (LA) and radiofrequency ablation (RFA) have been used to treat thyroid nodules. However no studies comparing LA and RFA have been published so far.

Aims of the study

1. To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up
2. To evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound, contrast-enhanced ultrasound, power-doppler and core-biopsy influence LA and RFA outcomes
3. To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA.
4. To evaluate differences between LA and RFA in terms of complications, side effects and tolerability.

Patients will be recruited, treated and followed at Santa Maria Goretti Hospital in Latina, Italy, by physicians with expertise in LA and RFA. The scientific coordinator of this study is dr. Silvia Manfrini.

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules

Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

Basal volume in mL of the nodules will be calculated with the ellipsoid formula

% of amount of fibrosis and colloid components evaluated with score-biopsy

Variation in TSH value (mUI/ml) before and after LA and RFA

Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA

Differences in the rate of complications and side effects between LA and RFA

Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version

Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.

Campus Bio-Medico University

Medical Doctor

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Liver Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Disease Attributes

Chronic Graft Versus Host Disease

Hematinics

Liver Extracts

Percutaneous Microwave Ablation

To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and survival have been retrospective. There have been no prospective randomized studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for HCC lesions \> 2 cm in patients with Child-Pugh A and B cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions \> 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.

Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation

Prospective Randomized Controlled Study Comparing Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy (MCT) Versus Percutaneous Radiofrequency Ablation (RFA) in Patients With Chronic Liver Disease and Hepatocellular Carcinoma

Centre Hospitalier Universitaire Dijon

To investigate whether CEUS-CT/MRI fusion imaging improved the visualization of small (≤ 3 cm) primary and secondary malignant liver tumors that were inconspicuous on B-mode US for percutaneous RFA.

In brief, ablation was performed using a 200-W multichannel generator and a switching monopolar technique with separate clustered electrodes. Tumor targeting was done under the guidance of CEUS-CT/MRI FI, and the ablation procedure was monitored with US-FI. The ablation procedure was terminated when the operator expected to complete the ablation of the index tumor with a minimum 5-mm ablative margin on the US-FI images.

Jeong Min Lee

Contrast-enhanced ultrasonography (CEUS)-CT/MRI fusion imaging substantially improved the visibility of small tumors that were inconspicuous on both US and US-CT/MRI fusion imaging, contributing to successful percutaneous radiofrequency ablation.

Percutaneous radiofrequency ablation (RFA) has been widely implemented as a curative treatment for liver malignancies. The overall survival post-RFA is comparable to that of surgical outcomes for small hepatocellular carcinomas (HCCs) (≤ 3 cm). US guidance for RFA is common in Asia because the real-time capability of US allows precise electrode placement. However, precisely targeting small liver malignancies with poor sonographic conspicuity in US-guided RFA is often challenging. To solve this problem, CEUS or real-time fusion imaging (FI) of US and CT/MRI have been used. Both approaches have been reported to improve the confidence for tumor localization in RFA for small HCCs with poor B-mode US visibility. However, when an index tumor is entirely invisible on B-mode US, neither method is ideal, especially for multiple-electrode RFA, due to inherent registration errors on FI or insonation-induced bubble destruction on CEUS with SonoVue. Therefore, there is a clinical need to compensate for the inherent registration errors of US-CT/MRI FI for inconspicuous tumors on both US and US-CT/MRI FI.

Recent studies reported that after adding CEUS using Sonazoid (GE Healthcare, Waukesha, WI, USA) or SonoVue to FI, 83.3% to 90% of target liver cancers that were initially difficult to visualize on FI became conspicuous, allowing them to be directly targeted for RFA. However, these studies had limitations, including a retrospective study design, a small sample size (\< 30 inconspicuous tumors), or a short-term follow-up (\< 1 year). Furthermore, no prospective study has explored the value of CEUS-CT/MRI FI, using both SonoVue and Sonazoid as contrast agents, for localizing index tumors and guiding RFA procedures in patients with inconspicuous tumors on B-mode US and reported its therapeutic impact on local tumor control.

Therefore, the present study investigated whether CEUS-CT/MRI FI improved the visibility of small (≤ 3 cm) primary and secondary liver tumors that were invisible or difficult to visualize on B-mode US for percutaneous RFA.

Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation

Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance for Percutaneous Radiofrequency Ablation of Inconspicuous, Small Liver Tumors

Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI)

The technical success of radiofrequency ablation is defined as complete ablation of tumor with safety margin and evaluated by immediate post-procedural computed tomography.

Seoul National University Hospital

Professor

We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).

percutaneous radiofrequency ablation (RFA)

Ragaey A Eid

In Egypt, chronic hepatitis C virus (HCV) is the most prevalent cause of hepatoma. The study aims to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC). The present study was a single-center, prospective non-randomized, controlled clinical trial in the Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals, between October 2018 and August 2021. Abdominal ultrasonography and triphasic computerized tomography (CT) abdomen were used to diagnose HCC. The abdominal ultrasonography and a dynamic CT scan were performed six weeks following the ablation to assess treatment efficacy.

Single-center, prospective non-randomized, controlled clinical trial

RFA for Treatment of Intermediate Stage HCC

Efficacy and Response Predictors of Percutaneous Radiofrequency Ablation for Treatment of Intermediate Stage Hepatocellular Carcinoma: A Controlled Clinical Trial

By evaluating the HCC biomarkers as serum AFP and VEGF

By accounting for the number of adverse events

Beni-Suef University

Benha University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Patients randomised to this arm will undergo a partial nephrectomy

Patients randomised to this arm will undergo radiofrequency ablation

Patients randomised to this arm will undergo cryoablation

Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass

Surgical treatment for renal mass

Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass

Percutaneous Radiofrequency ablation

Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass

Laparascopic or percutaneous cryoablation

Naeem Soomro

The number of people diagnosed with kidney cancer has doubled over the past 20 years, making it the eight most common cancer in the UK. Most tumours are less than 4cm in size, but over 80% of these are malignant (cancerous) and if left untreated, will slowly grow and spread. Current standard treatment for these small kidney cancers is to remove the diseased part of the kidney in an operation called a partial nephrectomy, but this can be quite a difficult operation. Because of the small tumour size and difficulties with the operation, other treatments have been developed to destroy the tumours. These treatments include radiofrequency ablation, which means that the tumour is destroyed by heat, and cryoablation, which means that the tumour is frozen and destroyed.

Although removing the part of the diseased kidney in an operation is the tried and tested way to treat the kidney cancer, it does have risks and complications, such as bleeding. The other two treatments are less intrusive to the patient, and are less complicated as they do not require such a large operation as having part of the kidney removed, but it is not known if they are as good at destroying all of the tumour, and whether or not patients who have their tumour destroyed with these new methods require further treatment in future.

In this study, the investigators are trying to determine if a large-scale study comparing these treatments is possible which is why this is called a feasibility study. The investigators are also looking at whether patients would be willing to be randomly assigned to a treatment group. The results of this study will then be compared to see how effective each of the treatments were and whether the number of patients who were happy to be randomly assigned to a treatment could be used to determine the number of patients required in a large-scale trial.

This study will be a multicentre study to determine if it is possible to carry out a future trial comparing the effectiveness of two minimally invasive techniques to remove small kidney cancers, with the standard treatment of removing part of the diseased kidney. In this future study, participants will be randomly assigned (randomised) to one of these three treatment options. This current study will look at whether patients would be willing to be randomised to a treatment type, whether sufficient numbers for a larger trial would be likely to be recruited within a certain time period, and also to decide what aspects of the conduct and outcomes of each of the three treatment types would need to be recorded in a largescale trial to compare their effectiveness.

Eligible participants for this study will be identified and will be invited to take part in the study by their clinicians currently involved in their kidney cancer assessment. They would then receive information about the surgery treatment (removing the diseases part of the kidney) and one of the alternative treatment methods (destroying the kidney cancer tumour using either heat or by freezing) in the participating hospital. If the patient was interested in participating in the study, they will be asked to consent to be randomised to one of the two treatment types they were given the information about.

If a patient declines to be randomised to a treatment, they will be asked to participate in a series of interviews, to establish the reasons behind why they declined, such as if they had a preference for one of the treatments.

Those patients that consent to being randomised to one of the treatment arms will undergo a screening visit to confirm their eligibility for this study, and at this visit they will have a blood sampke taken and be asked to complete some questionnaires about their general health and how they feel. This is so that any questionnaires completed at a later date after treatment will be compared to how the patient responded before treatment, in order to look for any changes or improvements to the patients. Once they have been confirmed as eligible, they will be randomised to a treatment arm,, and a hospital appointment for their treatment will also be made at this time.

At the treatment visit, each patient will be admitted to hospital for their treatment as scheduled, and will be kept in hospital for the recommended duration after their operation. Those having the diseased part of the kidney removed will be kept in hospital for 35 days, those having their kidney cancer frozen using cryoablation will be kept in hospital for 2 days, and those having their kidney cancers destroyed using heat (radiofrequency ablation) will be kept in for one day.

As per standard care, this duration of time in hospital could vary if the patient experiences any unexpected complications. They will also have some blood samples taken at this visit to assess their kidney function.

All treatments will be given by a qualified specialist surgeon with extensive experience in the treatment they are giving the patient.

Three months after their treatment, each patient will be asked to return to their hospital for a followup visit. At this visit, the patients will be asked to complete the same questionnaires as was completed previously, as well as to undertake a CT scan to assess if the treatment they were given was successful and to determine if all the kidney cancer was removed or destroyed. This CT scan is for patients who undergo cryoablaton treatment only. Patients who undergo radiofrequency ablation treatment will have a CT scan one month after treatment. All patients will also have a blood sample taken at this visit to assess their kidney funtion.

Six months after their treatment, each patient will be asked to return to their hospital for a followup visit, at which point patients undergoing cryoablation treatment will once again have a CT scan to assess if their treatment remains a success, and to determine if all the kidney cancer is still destroyed or whether some of it has returned. They will be asked to complete the questionnaires from previous visits one more time, so as to compare how they feel and how their general health has improved or changed from previously.

Patients who undergo radiofrequency ablation treatment or cryoablation treatment will be required to attend for a further final visit within 2 weeks of their 6 month followup visit in order to have a kidney biopsy taken to determine if their treatment remains a success and all of the cancer mass has been destroyed.

After these six months, and five visit, the patient will return to their normal standard clinical followup visits, which they would be having whether they were on the study or not.

As well as these mentioned visits, some patients who consent to be randomised, will also be asked to consent to being involved in a series of interviews, at which times they will be asked general questions on how they feel in general and about the treatments they have received.

A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)

CONSERVE: a Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery (Partial Nephrectomy) With Needle Ablation Techniques (Radiofrequency Ablation/Cryotherapy) for the Treatment of People With Small Renal Masses (4cm)

To estimate the proportion of patients with renal masses \< 4cm who agree to trial registration and accept randomisation to either partial nephrectomy or one of the ablative techniques

To review responses and patients willingness to complete this questionnaire over the course of their involvement in the study

To review responses and patient's willingess to complete this questionnaire during the course of their involvement in the study

To review response and patients willingness to complete this questionnaire during the course of their involvement in the study

The timing of these CT scans is dependent on the treatment arm the patient is randomised to.

This renal biopsy is only applicable to patients undergoing ablative treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation	NCT02859753	Thermoablation Chronic Liver D... Hepatocellular ...	Percutaneous Ra... Percutaneous Mi...	18 Years -	Centre Hospitalier Universitaire Dijon
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
Added Value of Contrast-enhanced Ultrasonography for Percutaneous Radiofrequency Ablation	NCT05445973	Radiofrequency ... Ultrasonography Liver Tumors	Percutaneous Ra...	-	Seoul National University Hospital
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
RFA for Treatment of Intermediate Stage HCC	NCT05281783	Hepatocellular ...	percutaneous ra...	-	Benha University
A Feasibility Study for a Multicentre Randomised Controlled Trial to Compare Surgery With Needle Ablation Techniques in People With Small Renal Masses (4cm)	NCT01608165	Renal Cancer	Surgical treatm... Percutaneous Ra... Laparascopic or...	18 Years -	Newcastle-upon-Tyne Hospitals NHS Trust

Spots Global Cancer Trial Database for percutaneous radiofrequency ablation