Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.
The prevalence of hypertension dramatically increased. Although most cases of hypertension are idiopathic, some cases have an identifiable cause. Primary Aldosteronism (PA) is the most common cause of secondary hypertension and can be cured by surgery if PA is due to unilateral unique adrenal adenoma. Then this cause is worth identifying it. The surgery despite its minimally invasive nature is limited by the need for general anesthesia, the risk of vascular or visceral injuries, hematomas and all the adrenal gland is mostly removed. Imaged-guided percutaneous adrenal radiofrequency ablation (ARF) offers a less invasive alternative therapeutic option. This local therapy is employed to treat solid neoplasms whereas its application on functional adrenal adenoma is less documented and only a few case series with limited sample size are published. The impact on blood pressure control is not clearly reported. ARF ablation works by delivering a high-frequency alternating current through a needle electrode. An ionic agitation occurs and generates frictional heat for cell destruction at a predictable temperature and volume. Patients with a conventional documented PA due to unilateral adrenal nod who consented to the study were hospitalized. Patients with PA due to an aldosterone-producing adenoma are included in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation | Experimental | Radiofrequency ablation (RFA) is a minimally invasive technique for eliminating both primary tumors and metastases. The needles that will be used are monopolar RFA, the LeVeenâ„¢ Needle Electrode Family with a generator "RF 3000" by Boston Scientific. The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Device | The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| mean day-time systolic/diastolic blood pressure | mean day-time systolic/diastolic blood pressure <135/85 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment or a decrease of daytime systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| day-time systolic and diastolic blood pressure | To assess a decrease of day-time systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months |
| mean 24 hours systolic/diastolic blood pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Béatrice DULY-BOUHANICK, Pr | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | ||||
| CHU de Toulouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36380152 | Result | Costa N, Mounie M, Gombault-Datzenko E, Boulestreau R, Cremer A, Delchier MC, Gosse P, Lagarde S, Lepage B, Molinier L, Papadopoulos P, Trillaud H, Rousseau H, Bouhanick B. Cost Analysis of Radiofrequency Ablation for Adrenal Adenoma in Patients with Primary Aldosteronism and Hypertension: Results from the ADERADHTA Pilot Study and Comparison with Surgical Adrenalectomy. Cardiovasc Intervent Radiol. 2023 Jan;46(1):89-97. doi: 10.1007/s00270-022-03295-9. Epub 2022 Nov 15. | |
| 33196558 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D000182 | ACTH Syndrome, Ectopic |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D009384 | Paraneoplastic Endocrine Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
mean 24 hours systolic/diastolic blood pressure <130/80 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment
| 6 months |
| mean day-time ambulatory blood pressure | mean day-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months |
| mean night-time ambulatory blood pressure | mean night-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months |
| mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure | mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months |
| casual systolic blood pressure / diastolic blood pressure | casual systolic blood pressure / diastolic blood pressure <140/90 mmHg after adrenal radiofrequency ablation, at six months without antihypertensive treatment | 6 months |
| decrease of casual systolic blood pressure | decrease of casual systolic blood pressure of 20 mmHg and of casual diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months |
| mean daytime ambulatory blood pressure changes assessed by self-measurement | mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months | 6 months |
| antihypertensive agents | number of antihypertensive agents at 6 months after adrenal radiofrequency ablation | 6 months |
| kalemia | evaluation of kalemia at month 1 and month 6 | 6 months |
| CT Scan | description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation | 6 months |
| post-operative complications | post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection | 6 months |
| cost-effectiveness | cost-effectiveness radiofrequency ablation | 6 months |
| Toulouse |
| 31059 |
| France |
| Result |
| Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708. |
| D010257 | Paraneoplastic Syndromes |
| D009369 | Neoplasms |