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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02225-42 | Other Identifier | ID-RCB |
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Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%.
More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma.
Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.
Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of PA.
Medical therapy or adrenalectomy are the 2 options to be considered. Laparoscopic adrenalectomy (LA) has been reported to be cost-effective compared with lifelong oral administration alone in unilateral PA.
Therefore, LA is the gold standard for unilateral PA to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of BP control with an overall complication rate of 5 to 14%.
More recently, radiofrequency ablation (RFA) has been used for patients with APA with an hormonal success obtained in 92% of patients treated by umbrella-shaped needle .
RFA for hypertensive patients with APA seems to be an emerging promising alternative to surgery. . Investigator team anticipate that radiofrequency allows a hormonal success of the same order than with adrenalectomy (around 95%), with simpler follow-up than surgery.
The main objective of the study is to test the non-inferiority of radiofrequency ablation compared to adrenalectomy, among hypertensive patients with primary aldosteronism and unilateral adrenal adenoma in order to normalize hormonal endpoints at 3 months of follow-up.
Cost-effectiveness and cost-utility analysis will be conducted to assess the efficiency of radiofrequency in the frame of the project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated by RFA -radiofrequency ablation | Experimental | patients with primary aldosteronism would be treated by RFA using needle electrodes |
|
| Patients treated by adrenalectomy | Active Comparator | Patients with primary aldosteronism would be treated by adrenalectomy. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA -radiofrequency ablation | Procedure | Under real-time multidetector CT-guidance, the patients will be put in either prone or lateral decubitus position to choose for the optimal access route for RFA needle electrode. Under multidetector CT guidance, patients would be treated with regard to optimal RFA needle access route with a hydrodissection or aero dissection if necessary. 2 types of generator (Boston Scientific RF 3000, and Ablatech Amica) and of needle electrodes (Leveen-type extendable, Ablatech) will be used according to the routine care of the centers |
| Measure | Description | Time Frame |
|---|---|---|
| aldosterone-to-renin ratio (ARR) after 15min in the sitting position | aldosterone-to-renin ratio (ARR) after 15 min in the sitting position. Following the recommendations given by Douillard et al (15), normalisation of the ARR will be defined (according to the measurement method) using:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success at 3 months | Clinical success, defined according to PASO outcome definitions at 3 months of follow-up, assessed by ambulotary blood pressure monitoring :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bérengère BACHELET | Contact | 0561322719 | +33 | bachelet.b@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Recruiting | Toulouse | France |
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| Adrenalectomy | Procedure | Adrenalectomy may be performed using a laparoscopic or open approach. In either approach, the gland may be approached transabdominally or retroperitoneally. The choice of surgical approach depends on the size and nature of the lesion, the patient's general characteristics and the expertise of the surgeon. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients |
|
| 3 months |
| Clinical success at 6 months | Clinical success, defined according to PASO outcome definitions at 6 months of follow-up, assessed by ambulotary blood pressure monitoring :
| 6 months |
| Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up | Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L | 1 month |
| Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up | Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L | 3 months |
| Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up | Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up. Hypokalaemia is defined as serum potassium of <3·6 mmol/L | 6 months |
| Biochemical success at 3 months of follow-up | Biochemical success at 3 months of follow-up. Complete Biochemical success: correction of hypokalaemia (if present pre-intervention) and normalisation of the aldosterone-to-renin ratio Partial biochemical success: Correction of hypokalaemia (if present pre-intervention) and a raised aldosterone-to-renin ratio with one or both of the following (compared with pre-intervention): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-intervention confirmatory test result Absent biochemical success: Persistent hypokalaemia (if present pre-intervention) or persistent raised aldosterone-to-renin ratio, or both | 3 months |
| mean changes in Blood Pressure values assessed by ABPM at 3 months | The mean changes in 24-hour, daytime and nocturnal Systolic BP/diastolic BP values will be assessed by ABPM between pre-inclusion and 3 months | 3 months |
| mean changes in Blood Pressure values assessed by ABPM at 6 months | The mean changes in 24-hour, daytime and nocturnal Systolic BP/diastolic BP values will be assessed by ABPM between pre-inclusion and 6 months | 6 months |
| normalisation of office BP at 6 months | The normalisation of office BP after 6-month of follow-up will be defined by Systolic BP/diastolic BP values <140/90 mmHg without any treatment; BP will be measured with an oscillometric method: Dynamap, used in routine care, in a sitting position after 5 minutes' rest. | 6 months |
| The use of antihypertensive agents at 6 months after RFA and after surgery | The use of antihypertensive agents at 6 months after RFA and after surgery. The number and defined daily dose (DDD, using the last index version, https://atcddd.fhi.no/atc\_ddd\_index/) of antihypertensive agents will be assessed | 6 months |
| surface area destroyed by radiofrequency | In the RFA group, at 3 months of follow-up, the surface area destroyed and preservation of the adrenal gland around will be assessed by adrenal CT scan: Patients will undergo adrenal scan without and with injection of contrast product after verification of renal function. | 3 months |
| Number of Adverse events | Adverse events will be collected and serious adverse events reported in the 2 groups at each visit until the end of the study | 6 months |
| length of stay | Number of days of hospitalisation | 6 months |
| Health economic criterion | Direct medical, non-medical costs and costs related to absence from the workplace | 6 months |
| ID | Term |
|---|---|
| D018246 | Adrenocortical Adenoma |
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| D007008 | Hypokalemia |
| ID | Term |
|---|---|
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D000308 | Adrenocortical Hyperfunction |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000315 | Adrenalectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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