[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658194":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":49,"interventions":56,"overallOfficials":64,"centralContacts":68,"locations":41,"responsibleParty":74,"collaborators":41,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":41,"enrollmentInfo":88,"targetDuration":41,"studyType":91,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":99,"whyStopped":41,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":41},{"fullName":5,"class":6},"Herlev Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival","Time from index date (first day of systemic oncological therapy or first visit at the Department of Oncology (for patients who do not receive systemic therapy)) to death from any cause. Participants alive at the time of last follow-up will be censored at that date.","From index date until death from any cause, assessed up to 4 years",[14,18,22,26,30,34,37],{"measure":15,"description":16,"timeFrame":17},"Progression- and metastatic-free survival","Time from index date to radiological progression of the primary tumor or development of distant metastases, assessed according to RECIST 1.1 on cross-sectional imaging.","From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years",{"measure":19,"description":20,"timeFrame":21},"Local tumor control at 6 and 12 months","Proportion of participants with local tumor control (absence of local progression) on cross-sectional imaging at 6 and 12 months, assessed according to RECIST 1.1.","At 6 and 12 months after index date",{"measure":23,"description":24,"timeFrame":25},"Procedure-related adverse events","Adverse events occurring within 30 days of each EUS-RFA treatment, graded according to the AGREE classification.","At 30 days after each EUS-RFA procedure",{"measure":27,"description":28,"timeFrame":29},"Time to biliary\u002Fduodenal intervention","Time from index date to first biliary or duodenal intervention (e.g., stenting)","From index date until intervention or last follow-up, assessed up to approximately 4 years",{"measure":31,"description":32,"timeFrame":33},"Pain score change compared to baseline","Change from baseline in pain severity, measured using a Numeric Rating Scale (NRS, 0-10)","Baseline and at 6, 12 and 18 months after inclusion",{"measure":35,"description":36,"timeFrame":33},"Opioid consumption change compared to baseline","Change in opioid consumption, converted to total daily oral morphine milligram equivalent (MME).",{"measure":38,"description":39,"timeFrame":40},"Quality of Life change compared to baseline (EORTC QLQ-C30)","Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Global Health Status\u002FQuality of Life scale, ranging from 0 (worst) to 100 (best), with higher scores indicating better quality of life.","Baseline and at 6, 12 and 18 months",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"NA","SINGLE_GROUP","A historical control group will be used as a comparitor.","TREATMENT",{"masking":48,"maskingDescription":41,"whoMasked":41},"NONE",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"EUS-RFA plus standard oncological treatment","EXPERIMENTAL","Participants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using a 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) connected to an RF generator, as a supplement to standard palliative oncological treatment. EUS-RFA is performed under deep sedation or general anesthesia and may be repeated at approximately 4-week intervals contingent on patient condition. All participants continue standard oncological follow-up, including systemic therapy and regular cross-sectional imaging, in parallel with the study intervention.",[55],"Procedure: Endoscopic ultrasound-guided radiofrequency ablation",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"PROCEDURE","Endoscopic ultrasound-guided radiofrequency ablation","A 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) is introduced through the working channel of an echoendoscope and advanced into the pancreatic tumor under real-time ultrasound guidance.\n\nThe needle is connected to a dedicated RF generator delivering a current of 400-500 kHz, which induces coagulative necrosis in the targeted tissue. Treatment is continued until complete ablation is confirmed ultrasonographically, or until an impedance value of 800 Ω is reached, at which point the generator automatically terminates power output to limit further tissue damage. A cooling pump circulates chilled saline through the needle to reduce charring at the ablation site. The procedure is performed transgastrically or transduodenally under deep sedation or general anesthesia, and may involve one or more ablation cycles per session. Treatment may be repeated at approximately 4-week intervals, depending on radiological response and patient tolerance.",[51],[63],"EUS-RFA",[65],{"name":66,"affiliation":5,"role":67},"Bojan Kovacevic, MD, PhD","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":41,"email":73},"Clara Søndersted, MD","CONTACT","45 38683868","clara.theodora.soendersted@regionh.dk",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Bojan Kovacevic","Consultant Surgeon, Surgical Gastroenterology, Sponsor-Investigator","100658194","pancreatic-endoscopic-ultrasound-guided-radiofrequency-for-inoperable-carcinoma-treatment-100658194",false,"NCT07850336","Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment","Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)","PERFECT","Inclusion Criteria:\n\n* Adult habile patients with a signed informed consent\n* Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter\n* ECOG performance status 0-2\n* Patients not eligible for curative-intended surgical treatment due to:\n\nAdvanced (unresectable) disease, or Unsuitability for surgery due to comorbidities or poor performance status, or Patient preference to decline surgery\n\nExclusion Criteria:\n\n* Metastatic disease\n* Uncorrected coagulopathy (INR ≥1.5 or thrombocyte count \\\u003C 50 mia\u002FL)\n* Altered anatomy or interposition of major vessels precluding safe EUS-RFA\n* Active untreated infection or pancreatitis\n* Life expectancy \\\u003C3 months\n* Prior local ablative treatment interfering with outcome","ALL","18 Years",{"count":89,"type":90},56,"ESTIMATED","INTERVENTIONAL",[43],"The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. By using a prospective single-arm design with historical controls, this study aims to generate clinically relevant data while minimizing the number of patients exposed to experimental treatment. The findings may support future integration of EUS-RFA into standard care for this high-need patient population.",[95],"Pancreatic Ductal Adenocarcinoma (PDAC)",[63,97,98],"Endoscopic Ultrasound-Guided Radiofrequency Ablation","Locally Advanced Pancreatic Cancer","NOT_YET_RECRUITING","2026-09-24",{"date":102,"type":103},"2026-09-30","ACTUAL",{"date":105,"type":90},"2026-10-01",{"date":107,"type":90},"2030-12",{"name":76,"class":6}]