Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Neuroendocrine Tumors

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Pancreatic Cancer

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. All patients would undergo EUS with a linear array or therapeutic echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the EUSRA RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue.

A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.

EUSRA RFA needle

Yung Ka Chin, MBChB

Damein Tan, MBBS

This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency waves under ultrasound imaging. The subject who will be recruited into this study are patients who are deemed as non-surgical candidates.

RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.

The application of RFA in the pancreas was first described in 1999. Thereafter, several studies performed in the porcine model demonstrated the feasibility of RFA under EUS guidance. In the first porcine study by Goldberg et al, RFA was applied through a modified 19 gauge Vilmann-type needle (GIP/MediGlobe, Grassau, Germany). The needles were electrically insulated with shrink tubing for all but the distal 1 to 1.5cm. 16 ablations were performed and the procedure resulted in hypodense foci of non-enhancing pancreas 1 to 2 days after ablation. Pathologic examination showed well demarcated spherical foci of coagulation necrosis measuring 8 to 12mm in size. One swine developed hyperlipasemia, a focal zone of pancreatitis and another with pancreatic fluid collection. 4 swine also suffered from thermal injury to the gastrointestinal wall caused by improper electrode placement.

Thereafter, 4 subsequent porcine studies also demonstrated the feasibility of RFA under EUS guidance with proprietary radiofrequency electrodes. In the most recent study, EUS-guided RFA was delivered by a novel 18-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). RFA was applied to both the ex-vivo and in-vivo models to determine the optimum power settings and efficacy of the device. A power setting of 50 W for 6 minutes was shown to result in the most effective depth and size of ablation zone, whilst a higher power setting resulted in tissue charring and reduced the conductive coagulative necrosis effect. 10 swine then received EUS-guided RFA to the pancreas and the mean size of the ablated lesions were 23 +/- 6.9mm. None of the swine suffered from any adverse events and there were no significant changes in the serum levels of amylase and lipase, both before and after the procedures.

On the other hand, the experience of RFA in human pancreas is accumulating. Earlier studies using first generation percutaneous RFA probes applied intra-operatively to pancreatic carcinomas were associated with unacceptably high rates of mortality (0% - 25%) and morbidity (0% - 40%). Subsequently, human data on new generation EUS-guided RFA probes with improved design and outcomes have become available. 22 patients with locally advanced pancreatic ductal adenocarcinoma were treated the cryotherm probe (CTP) (ERBE Elektromedizin GmbH, Tübingen, Germany). The CTP was successfully applied in 16 patients (72.8%), amylase rose in 3 of 16 patients but none had clinical signs of pancreatitis. The median post ablation survival time was 6 months. In another 2 studies, the Habib RFA catheter was used (EMcision, United Kingdom). 7 patients with unresectable pancreatic ductal carcinoma and 8 patients with pancreatic neuroendocrine tumour and cystic tumours were treated with EUS-guided RFA. In patients suffering from pancreatic ductal carcinoma, post procedural imaging showed a decrease in size of the lesions in 2 patients and 1 patient suffered from mild pancreatitis. Whilst in patients with cystic neoplasms and neuroendocrine tumours, all showed complete resolution or reduction in size of the lesions. Only 2 patients suffered from abdominal pain that resolved spontaneously. On the other hand, RFA with the VIVA generator was applied in 6 patients with unresectable pancreatic adenocarcinoma. Two patients suffered from mild abdominal pain but no serious adverse events reported.

Thus, based on these preliminary results, we conclude that the new generation EUS-guided RFA probe is safe and feasible. The next stage in development with conduction of this study would involve recruitment of larger patient cohorts to further establish the efficacy and risk profile of the procedure.

HYPOTHESIS AND OBJECTIVES The aim of the current study is to perform a single center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. We hypothesize that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.

EXPECTED RIKS AND BENEFITS The expected risks for the patients include mild abdominal pain. The benefit may include RFA destroy the tumour cells via coagulative necrosis process hence providing some form of disease control. Besides, the current study could establish the safety and feasibility of EUS-guided RFA of solid pancreatic neoplasms. These results could provide insights as to whether the procedure is comparable to surgery for treatment of these lesions in the future.

STUDY POPULATION We aim to recruit 10 subjects over the period of 18 months. The subjects must have pancreatic neuroendocrine tumour or pancreatic ductal carcinoma that was unsuitable for surgery or not keen for surgery.

STUDY DESIGN AND PROCEDURES/METHODOLOGY The RFA system It consists of two components, a19-gauge RFA electrode and a VIVA combo RF generator. The total length of the electrode including the delivery system is 150 cm. The distal end of the electrode is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds.

EUS-guided radiofrequency ablation This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. Post procedural, the site of needle entry would be inspected endoscopically to assess for presence of thermal injury to the gastrointestinal wall.

Follow-up protocol There will be clinic visit scheduled by both gastroenterologist and oncologist at two weeks after discharging from hospital to review participant's condition and to plan for further treatment. Follow-up phone call will be made at 1st week and 1st month after discharging from the ward to determine for any adverse event and whether they are attributable. When reporting complication rates, only definite and probably attributable events occurring within 30 days will be include.

Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms

Evaluation of Safety and Feasibility of Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) for Solid Pancreatic Neoplasms

IPD on study protocol will be made available

It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle.

Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events (PB Cotton GIE 2010). Potential adverse events specific to RFA include:

* Post-RFA syndrome: Combination of flu like symptoms including fever, malaise, pain at the site of ablation, nausea, and/or vomiting and that no other septic source is identified.
* Pancreatitis: Clinical presence of abdominal pain with an increase in amylase level \>3 times above the normal serum amylase levels.
* Pancreatic leak: The presence of an abdominal collection with an amylase level that is \>3 times normal serum amylase levels.
* Thermal injury: Coagulative necrosis occurring at the site of needle entry within the gastrointestinal tract with or without clinical sequelae.

Singapore General Hospital

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Bile Duct Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Gallbladder Cancer

The study group (A) will receive radio frequency ablation followed by uncovered Self expandable metal stent/Plastic stent placement (one or more)at same procedure.

The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement.

Radiofrequency ablation (RFA) uses heat to kill cancer cells. High-frequency electrical currents are passed through a special needle or probe called a needle electrode. The electrical current from the probe heats a small area containing cancer cells to high temperatures, killing the cancer cells. The area around the tumour is also usually treated because it may contain cancer cells.

Radio frequency ablation

Sai Dr Kumar, MBBS MD

Rajesh Mr Goud, M.Pharma, MBA, PDCR

Rajesh Goud, M.Pharma MBA

Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study.

Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo biliary stent placement and considered under control arm Patient opting for radio frequency ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary stent placement and considered under Study arm The RFA probe will be inserted into the bile duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation site for an additional 1 minute to allow the RFA probe to cool before removal to prevent thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA application, an uncovered SEMS/Plastic stent will be placed.

Placement of self expandable metallic stent is the standard of care in the palliative management of patients with malignant biliary strictures . Relieves biliary obstruction and jaundice.

Self expandable metallic stent provide efficient drainage and have superior patency rates compared with the plastic stents Endoscopic radio frequency ablation combined with stent placement can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.

Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to stent placement would have better outcomes.

RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY

satety of radio frequency ablation assessed by complications/adverse effects post procedure and efficacy of the procedure will be assessed by stent patency at the end of one month

Stent patency will be estimated by bio chemical parameters (Total bilirubin, Alkaline phosphatase) or ultra sound abdomen scan

Asian Institute of Gastroenterology, India

Doctor

Radio frequency ablation of pancreatic neuroendocrine tumors

Espen Thiis-Evensen, MD, PhD

Jon Sponheim, MD. PhD

Jon Sponheium, MD,PhD

A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.

Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

To register number of patient experiencing adverse events to the radiofrequency ablation procedure

To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation

To register number of patient who develop of local or distant metastases

Haukeland University Hospital

St. Olavs Hospital

University Hospital of North Norway

Oslo University Hospital

Senior consultant, MD, PhD

Symptoms and General Pathology

Cholangiocarcinoma

Constriction, Pathologic

Cholestasis

Pathological Conditions, Anatomical

Bile Duct Cancer

Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.

Any probe that can conduct radiofrequency ablation within biliary ducts.

Radio Frequency ablation Probe

Michel Kahaleh, MD

Monica R Gaidhane, MD, MPH

William R Brugge, MD

The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.

The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.

The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:

1. To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
2. To assess the immediate and 6 months post procedure adverse event rate in patients.
3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.

Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.

Documentation of response rates,overall survival duration and overall stent occlusion-free duration.

Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.

Weill Medical College of Cornell University

Chief, Advanced Endoscopy

Carcinoma, Renal Cell

Ischemia

Kidney Neoplasms

Kidney Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.

Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.

zero ischemia laparoscopic RFA assisted TE

conventional laparoscopic partial nephrectomy

ischemia

Yiran Huang, M.D.

To evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

National Natural Science Foundation of China

RenJi Hospital

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions

Kenneth K Wang, MD

The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).

Cryotherapy -BEATS-RF Ablation Trial

CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation

To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA

To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy

Mayo Clinic

Kathy and Russ VanCleve Professor of Gastroenterology Reserach

Immune System Diseases

Adenoma

Adrenal Insufficiency

Cushing Syndrome

Adrenocortical Hyperfunction

Hyperaldosteronism

Addison Disease

Hypoaldosteronism

Syndrome

Adrenal Gland Diseases

Cushing's Syndrome

Hyperadrenalism

Addison's Disease

Anti-Infective Agents

Anti-Inflammatory Agents

Vasoconstrictor Agents

Respiratory System Agents

Anti-Bacterial Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Antibiotics, Antitubercular

Racepinephrine

Epinephryl borate

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

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.

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 \< 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.

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.

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.

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

EUS-RFA of left adrenal tumour in PA with AVS-verified left lateralisation

EUS-RFA of left adrenal tumour in PA, "debulking group"

EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation

EUS-RFA of left adrenal tumour in MACS with bilateral overproduction, "debulking group

Marianne Grytaas, MD phd

Roald Havre, MD PhD

Kristian Løvås, MD Phd

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.

Study group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment.

Study 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.

Study 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.

Primary aldosteronism (PA) is the most common cause of secondary hypertension, and is associated with worse cardiovascular outcome than primary hypertension. Early diagnosis and treatment is paramount to avoid excess morbidity and death. The two main forms of PA are unilateral PA, often caused by an aldosterone-producing adenoma (APA), and bilateral PA. Differentiation between unilateral and bilateral disease determines treatment options. Adrenal vein sampling (AVS) is the recommended procedure to determine PA subtype, unilateral or bilateral. For unilateral PA surgery with unilateral adrenalectomy is recommended treatment. For PA without fulfilling lateralisation criteria, life-long medical treatment is recommended.

Mild autonomous cortisol production (MACS) is present in 20-30% of all adrenal incidentalomas, and is associated with the metabolic syndrome (hypertension, diabetes, obesity and osteoporosis). Therefore these patients carry increased risk of developing cardiovascular disease. Optimal treatment is debated, and based on the degree of MACS, degree of metabolic complications, and the patient's own opinion. Unilateral adrenalectomy is an option if the overproduction is unilateral, but in 15 % of cases, the overproduction is bilateral, and treatment strategy even more troublesome.

The left adrenal is situated in near proximity to the stomach and is easily reached by endoscopic ultrasound (EUS), and may be targeted for RFA, treating an aldosterone- or cortisol-producing tumour only, and spearing the remaining adrenal. In this study we introduce EUS-RFA as a new treatment option in the following patient groups:

Study group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment.

Study 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.

Study 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.

For all study groups, if CT scan shows an adrenal nodule to the left adrenal, nodule size must be \< 40 mm and enhancement value must fulfill criteria for a benign adenoma. Patients consenting to the EUS-RFA will have a EUS performed. If EUS of the left adrenal identifies an adrenal nodule, a fine needle tissue sampling will be performed. Thereafter EUS-guided RFA procedure of the tumour will be performed. After RFA treatment, the fine needle tissue sampling will undergo morphological and functional characterisation, including application of specific imaging mass cytometry for detection of aldosterone- or cortisol producing cells.

Clinical and biochemical outcome after EUS-RFA will be evaluated by the international PASO-criteria (PA) or ENSAT/ECE criteria (MACS). In patients with lateralised PA or lateralised MACS, clinical and biochemical outcome and postoperative hypoaldosteronism or hypocortisolism will be compared with conventional unilateral adrenalectomy. Inn all patients, procedural safety will be evaluated.

Four EUS-RFA intervention study groups Group 1: PA with lateralisation to left adrenal and left-sided tumour for EUS-RFA Group 2: PA with suspected left-sided overweight of aldosterone overproduction but not AVS-verified left-sided lateralisation for EUS-RFA as "debulking" procedure Group 3: MACS with unilateral tumour in the left adrenal and unilateral cortisol overproduction verified by AVS, for EUS-RFA Group 4: MACS with bilateral adrenal tumours and AVS-verified bilateral cortisol overproduction for EUS-RFA as "debulking" procedure

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

Biochemical outcome will be evaluated by international standardised "Primary aldosteronism surgery outcome" (PASO) criteria at follow-up visits after 3 and 1 year

Clinical outcome will be evaluated by international standardised PASO criteria at follow-up visits after 1 year

Biochemical outcome will be evaluated at follow-up visits after 3 and 1 year, evaluated by the international European Network for Study of Adrenal Tumour (ENSAT) /European Society of Endocrinology (ESE) criteria

Clinical outcome will be evaluated at follow-up visits after 3 and 1 year, evaluated by the international ENSAT/ESE criteria

Procedural complications of EUS-RFA compared with unilateral adrenalectomy will be performed using the Clavien-Dindo classification.

Length of hospital stay after EUS-RFA will be compared with adrenalectomy, and will be evaluated at follow-up after 3 months

Number of participants with postoperative hypoaldosteronism after EUS-RFA will be compared with unilateral adrenalectomy by biochemical assessment at 3 months after treatment

Number of participants with postoperative hypocortisolism after EUS-RFA will be compared with unilateral adrenalectomy. In patients with an abnormal pre-treatment 1 mg dexamethasone suppression test or a low morning cortisol \< 300 nmol/L after RFA or adrenalectomy, individual advise of cortisone acetate replacement therapy will be given and an stimulation adrenocorticotropic hormone (ACTH) test will be performed in the Endocrinology Out-patient clinic \~ 6 weeks of discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms	NCT03435770	Pancreatic Canc... Pancreatic Neop... Pancreatic Aden... Pancreatic Neur... Pancreatic Duct...	EUSRA RFA needl...	21 Years - 99 Years	Singapore General Hospital
RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION	NCT05320328	Bile Duct Neopl... Gall Bladder Ca...	Radio frequency...	18 Years - 75 Years	Asian Institute of Gastroenterology, India
Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms	NCT03435770	Pancreatic Canc... Pancreatic Neop... Pancreatic Aden... Pancreatic Neur... Pancreatic Duct...	EUSRA RFA needl...	21 Years - 99 Years	Singapore General Hospital
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms	NCT05243082	Pancreatic Neur...	Radio frequency...	18 Years -	Oslo University Hospital
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	NCT01439698	Cholangiocarcin... Pancreatic Canc... Bile Duct Cance... Biliary Strictu... Bile Duct Obstr...	Radio Frequency...	18 Years -	Weill Medical College of Cornell University
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage	NCT01838720	Renal Cell Carc... Zero Ischemia	zero ischemia l... ischemia	15 Years - 80 Years	RenJi Hospital
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry	NCT01439698	Cholangiocarcin... Pancreatic Canc... Bile Duct Cance... Biliary Strictu... Bile Duct Obstr...	Radio Frequency...	18 Years -	Weill Medical College of Cornell University
Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms	NCT03435770	Pancreatic Canc... Pancreatic Neop... Pancreatic Aden... Pancreatic Neur... Pancreatic Duct...	EUSRA RFA needl...	21 Years - 99 Years	Singapore General Hospital
Cryotherapy -BEATS-RF Ablation Trial	NCT01882478	Barrett's Esoph... Early Esophagea...		18 Years -	Mayo Clinic
Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism	NCT05368090	Primary Aldoste... Aldosterone-Pro... Hypercortisolis...	EUS-RFA of left... EUS-RFA of left... EUS-RFA of left... EUS-RFA of left...	18 Years - 80 Years	Haukeland University Hospital

Spots Global Cancer Trial Database for radio frequency ablation