[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467540":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":77,"collaborators":35,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":35,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":60,"whyStopped":35,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"EUS-RFA of PA with AVS-verified left lateralisation","EXPERIMENTAL","PA patients with AVS-confirmed lateralisation to the left adrenal and signed study consent will be included in this study group. EUS will be performed. If EUS identifies an adrenal nodule in the left adrenal, EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure will be performed. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.",[13],"Procedure: EUS-RFA of left adrenal tumour in PA with AVS-verified left lateralisation",{"label":15,"type":10,"description":16,"interventionNames":17},"EUS-RFA of PA without verified left lateralisation, for aldosterone \"debulking\"","PA patients with suspicion of aldosterone overproduction in their left adrenal, but without fulfilling the strict AVS lateralization criteria, either due to a non-representative AVS, or a representative AVS but without significant left-sided lateralization (LI \\\u003C 4), and where the study investigators consider EUS-RFA treatment as an aldosterone-reducing procedure to be of high potential clinical and biochemical benefit for the patient, will be included in this study group after signed consent. EUS will be performed. If EUS identifies an adrenal nodule in the left adrenal, an EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.",[18],"Procedure: EUS-RFA of left adrenal tumour in PA, \"debulking group\"",{"label":20,"type":10,"description":21,"interventionNames":22},"EUS-RFA of MACS with left lateralisation and left adrenal tumour","MACS patients with AVS-confirmed lateralisation the left adrenal gland and CT showing left-sided tumour will be included in this study group after signed consent. EUS will be performed, and a EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.",[23],"Procedure: EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation",{"label":25,"type":10,"description":26,"interventionNames":27},"EUS-RFA of MACS with bilateral cortisol overproduction and bilateral tumours","MACS patients with AVS-confirmed bilateral cortisol overproduction and bilateral tumours will be included in this study group after signed study consent. EUS will be performed, and EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.",[28],"Procedure: EUS-RFA of left adrenal tumour in MACS with bilateral overproduction, \"debulking group",[30,36,39,42],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","EUS-RFA of left adrenal tumour in PA with AVS-verified left lateralisation","Patients will fast, receive prophylactic antibiotics and conscious sedation prior to the endoscopic procedure.The procedure is performed with a standard linear echo-endoscope with a 3.7 mm or larger working channel. The left adrenal is identified from the fundus of the stomach. Color-Doppler is used to map adrenal vascularity. Ultrasound contrast is used to demarcate the border of the tumour. EUS-guided fine needle tissue sampling from tumour tissue is performed. The RFA ablation catheter is water-cooled and stable temperature is maintained at 70-75 degrees celsius until formation of heat bubbles can be seen on EUS. If necessary, the procedure is repeated after moving the probe until the whole adenoma volume is ablated. Ultrasound contrast medium is used after the procedure to ensure that the target for the ablation is non vascularized, before termination. The patients will be observed at the postoperative unit a few hours, and further in the ward for 24h",[9],null,{"type":31,"name":37,"description":33,"armGroupLabels":38,"otherNames":35},"EUS-RFA of left adrenal tumour in PA, \"debulking group\"",[15],{"type":31,"name":40,"description":33,"armGroupLabels":41,"otherNames":35},"EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation",[20],{"type":31,"name":43,"description":33,"armGroupLabels":44,"otherNames":35},"EUS-RFA of left adrenal tumour in MACS with bilateral overproduction, \"debulking group",[25],[46],{"name":47,"affiliation":5,"role":48},"Marianne Grytaas, MD phd","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":35,"email":53},"CONTACT","004741545435","marianne.grytaas@helse-bergen.no",{"name":55,"role":51,"phone":56,"phoneExt":35,"email":57},"Roald Havre, MD PhD","004790842938","roald.flesland.havre@helse-bergen.no",[59],{"facility":5,"status":60,"city":61,"state":35,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Bergen","5021","Norway","NO",{"type":66,"coordinates":67},"Point",[68,69],5.32415,60.39299,{"lat":69,"lon":68},[72,74],{"name":47,"role":51,"phone":73,"phoneExt":35,"email":53},"+4741545435",{"name":75,"role":51,"phone":35,"phoneExt":35,"email":76},"Kristian Løvås, MD Phd","kristian.lovas@helse-bergen.no",{"type":78,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100467540","endoscopic-ultrasound-guided-radiofrequency-ablation-in-primary-aldosteronism-100467540",false,"NCT05368090","Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism","Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism","Inclusion Criteria all groups\n\n* Signed written informed consent\n* If CT scan shows an adrenal nodule to the same adrenal as AVS lateralisation result: nodule size \\\u003C 4 cm and enhancement criteria for adrenal adenoma (native hounsfield units \\\u003C 10 or relative wash-out \\> 40% or absolute wash-out \\> 60%)\n\nPA unilateral group inclusion criteria:\n\n* Age 18 to 60 years\n* PA diagnosis confirmed according to Endocrine Society PA Guideline criteria\n* AVS lateralisation to left adrenal (lateralisation index ≥ 4,0)\n\nPA \"debulking\" group inclusion criteria:\n\n* Age 18 to 70 years\n* PA diagnosis confirmed according to Endocrine Society PA Guideline criteria\n\nMACS unilateral and debulking group inclusion criteria:\n\n* Age 18 to 80 years\n* MACS diagnosis confirmed according to ENSAT\u002FECE Guideline criteria\n* AVS lateralisation to the left adrenal, and visible left adrenal tumor on CT scan OR bilateral overproduction of cortisol on AVS, and bilateral tumors\u002Fhyperplasia on CT scan (debulking)\n\nExclusion Criteria all groups:\n\n* CT scan suspicion of adrenal malignancy\n* Patient refusal to undergo either EUS-RFA or adrenalectomy","ALL","18 Years","80 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"NA","In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural safety will be evaluated. In study patients with verified lateralised aldosterone or cortisol overproduction to the left adrenal, outcome will be compared with control groups performing conventional unilateral adrenalectomy.\n\nStudy group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment.\n\nStudy group 2: PA patient with suspected left-sided overweight of aldosterone production and a EUS-detectable tumour but without strict lateralisation of their aldosterone overproduction, for EUS-RFA treatment as an aldosterone \"debulking\" procedure.\n\nStudy group 3: patients with MACS with AVS-verified lateralisation of cortisol overproduction to the left adrenal and EUS-detectable tumour for EUS-RFA treatment Study group 4: patients with MACS with bilateral adrenal tumours and verified bilateral overproduction of cortisol for EUS-RFA treatment as a cortisol \"debulking\" procedure.",[97,98,99],"Primary Aldosteronism","Aldosterone-Producing Adenoma","Hypercortisolism",[101,102,103,104],"radio frequency ablation","postoperative hypoaldosteronism","postoperative hypocortisolism","metabolic comorbidity","2026-05-07",{"date":107,"type":108},"2026-05-08","ACTUAL",{"date":110,"type":108},"2022-06-03",{"date":112,"type":91},"2028-12-31",{"name":5,"class":6},1]