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
Institute for Clinical and Experimental Medicine
50 participants
Apr 11, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria17
- Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
- Capability of giving informed consent PCN Inoperability or refusal of surgery
- Branch duct IPMN (BD-IPMN) with worrisome features:
- Jaundice
- High grade dysplasia or cancer
- Solid mass/nodule > 5mm
- Main pancreatic duct dilation > 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:
- CA 19-9> 37 U/ml
- Increase in size > 5mm/year
- Dilation of the main pancreatic duct between 5-10mm
- Size ≥ 40mm
- Symptoms (new onset of diabetes, acute pancreatitis)
- Nodule < 5mm Pancreatic NET
- Size < 2 cm
- Histological proof in non-functional lesions/histological proof or clinical proof in functional lesions
- Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- G1 or G2 (<5 %) histology
Exclusion Criteria5
- 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
- Inability to sign the informed consent
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Interventions
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. 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.
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. 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.
Locations(1)
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NCT07536087