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.
EUS-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.
The 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.
Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
Capability of giving informed consent PCN Inoperability or refusal of surgery
Jaundice
High grade dysplasia or cancer
Known bleeding disorder that cannot be sufficiently corrected with medication
Use of anticoagulants that cannot be discontinued
Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
Pregnancy
Parallel
Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions
Procedure/SurgeryAll 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. EUS-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). For larger cysts, multiple applications or electrode repositioning may be performed to ensure adequate ablation.
Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions
Procedure/SurgeryAll 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. Radiofrequency 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/or electrode repositioning will be performed to ensure adequate ablation coverage.
Efficacy of EUS-RFA
Efficacy will be assessed by the rate of complete resolution, defined as disappearance or radiological evidence of necrosis of the target lesion, or significant response, defined as ≥80% reduction in lesion size on follow-up imaging.
Safety Profile
Safety will be assessed by the incidence of procedure-related complications, including pancreatitis, perforation, bleeding, and infection, as well as 30-day morbidity and mortality rates following EUS-guided radiofrequency ablation (EUS-RFA).
Technical Feasibility
Technical feasibility will be assessed by the success rate of complete EUS-guided radiofrequency ablation (EUS-RFA) of the target lesion. Additional parameters will include total procedure duration and the occurrence of technical difficulties (e.g., difficulty in lesion access, needle positioning, or energy delivery).
Functional Outcomes
Assessment of pancreatic function, defined by the occurrence of new-onset diabetes mellitus and/or pancreatic exocrine insufficiency following the intervention
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