[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634161":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":35,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":35,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":35,"enrollmentInfo":78,"targetDuration":35,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":49,"whyStopped":35,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Institute for Clinical and Experimental Medicine","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EUS-guided RFA of pancreatic cystic neoplasms (PCNs)","EXPERIMENTAL","Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic cystic neoplasms in inoperable patients or patients refusing surgery",[13],"Procedure: Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions",{"label":15,"type":10,"description":16,"interventionNames":17},"EUS-guided RFA of solid pancreatic lesions","Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic solid lesions, including PNET and other non-neuroendocrine solid lesions (e.g., metastases such as renal cell carcinoma)",[18],"Procedure: Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions","All procedures will be performed using a therapeutic linear-array EUS scope. In patients with pancreatic cystic neoplasm, a 19G or 22G needle will be used for cyst puncture and aspiration until only a minimal residual fluid layer remains to facilitate targeting; aspirated fluid may be used for biochemical and cytological analysis.\n\nEUS-guided radiofrequency ablation (EUS-RFA) will then be performed using an 18G or 19G internally cooled RFA needle (STARmed, Taewoong) connected to a temperature-controlled generator (VIVA RF). The electrode will be positioned within the cyst under real-time EUS guidance, and radiofrequency energy will be applied according to manufacturer settings (50 W, \\~100 Ω).\n\nFor larger cysts, multiple applications or electrode repositioning may be performed to ensure adequate ablation.",[9],[26,27],"EUS-RFA","EUS-guided RFA",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions","All procedures will be performed using a therapeutic linear-array EUS scope. In patients with solid pancreatic lesions, including PNET and non-PNET lesions (e.g., metastases such as renal cell carcinoma), an 18G or 19G internally cooled RFA needle (STARmed, Taewoong) will be advanced into the target lesion under real-time EUS guidance.\n\nRadiofrequency energy will be delivered using a temperature-controlled generator (VIVA RF) according to manufacturer settings (50 W, \\~100 Ω). The electrode will be positioned within the lesion prior to energy delivery. For larger lesions, multiple applications and\u002For electrode repositioning will be performed to ensure adequate ablation coverage.",[15],[26,27,33,34],"EUS-guided RFA of pancreatic solid lesions","EUS-guided RFA of PNET",null,[37,42],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Jana Jarosova, MD, PhD","CONTACT","420261363282","jana.jarosova@ikem.cz",{"name":43,"role":39,"phone":44,"phoneExt":35,"email":45},"Gabriela Petranova","420261365154","gabriela.petranova@ikem.cz",[47],{"facility":48,"status":49,"city":50,"state":35,"zip":51,"country":52,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology","RECRUITING","Prague","140 21","Czechia",{"type":54,"coordinates":55},"Point",[56,57],14.42076,50.08804,{"lat":57,"lon":56},[60,62,64],{"name":38,"role":39,"phone":61,"phoneExt":35,"email":41},"00420261363282",{"name":43,"role":39,"phone":63,"phoneExt":35,"email":45},"00420261365154",{"name":65,"role":66,"phone":35,"phoneExt":35,"email":35},"Jana Jarosova","PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":65,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Deputy Head of Inpatient Ward, Department of Gastroenterology and Hepatology","100634161","endoscopic-ultrasound-guided-radiofrequency-ablation-for-pancreatic-cystic-neoplasms-and-pancreatic-neuroendocrine-tumors-100634161",false,"NCT07536087","Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors","Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Neuroendocrine Tumors","Inclusion Criteria:\n\n* Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team\n* Capability of giving informed consent PCN Inoperability or refusal of surgery\n* Branch duct IPMN (BD-IPMN) with worrisome features:\n* Jaundice\n* High grade dysplasia or cancer\n* Solid mass\u002Fnodule \\> 5mm\n* Main pancreatic duct dilation \\> 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:\n* CA 19-9\\> 37 U\u002Fml\n* Increase in size \\> 5mm\u002Fyear\n* Dilation of the main pancreatic duct between 5-10mm\n* Size ≥ 40mm\n* Symptoms (new onset of diabetes, acute pancreatitis)\n* Nodule \\\u003C 5mm Pancreatic NET\n* Size \\\u003C 2 cm\n* Histological proof in non-functional lesions\u002Fhistological proof or clinical proof in functional lesions\n* 68Ga-DOTATATE PET\u002FCT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases\n* G1 or G2 (\\\u003C5 %) histology\n\nExclusion Criteria:\n\n* Known bleeding disorder that cannot be sufficiently corrected with medication\n* Use of anticoagulants that cannot be discontinued\n* Physical and\u002For psychological inability to understand the aims of the research and to adequately cooperate\n* Pregnancy\n* Inability to sign the informed consent","ALL","18 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83],"NA","The primary aim of this study is to evaluate the technical feasibility and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in the treatment of pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs) in patients who are not suitable candidates for surgical treatment or who refuse surgery.\n\nEUS-RFA, as a minimally invasive therapeutic option, may potentially reduce the need for intensive imaging surveillance, prevent further progression of these lesions, and serve as a bridging therapy in selected patients for whom surgical intervention may be considered in the future. At the same time, EUS-RFA could contribute to reducing overtreatment, thereby lowering the risk of complications associated with surgical procedures and leading to an overall reduction in healthcare costs.\n\nThe secondary objectives of the study are to evaluate the safety profile of EUS-RFA, including the incidence and severity of adverse events both in the early postoperative period and during the first year of follow-up, as well as to assess the long-term efficacy of EUS-RFA, including disease progression.",[86,87,88],"Endoscopic Ultrasound-Guided Radiofrequency Ablation","Pancreatic Neuroendocrine Tumors (pNET)","Pancreatic Cystic Neoplasms",[90,91,27,92,93,94],"Pancreatic Cystic Neoplasm","Intraductal papillary mucinous neoplasm","Pancreas","Neuroendocrine tumor","Radiofrequency ablation","2026-04-11",{"date":97,"type":98},"2026-04-17","ACTUAL",{"date":95,"type":98},{"date":101,"type":80},"2029-12-31",{"name":5,"class":6},1]