Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors

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.

Pancreatic lesions, including pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs), represent a heterogeneous group of diseases with variable biological behavior, ranging from benign and indolent entities to lesions with significant malignant potential. Their detection has markedly increased over the past two decades, primarily due to the widespread use of high-resolution imaging modalities such as computed tomography (CT) and magnetic resonance imaging (MRI). Incidental pancreatic cystic lesions are currently identified in up to 20% of abdominal imaging studies performed for unrelated indications, with prevalence rising with age. Consequently, the clinical burden associated with these lesions is expected to increase substantially in aging populations. The management of pancreatic lesions remains challenging and requires a careful balance between the risk of malignant transformation and the morbidity associated with intervention. PCNs encompass both non-neoplastic lesions (e.g., pseudocysts) and neoplastic entities, including intraductal papillary mucinous neoplasms (IPMNs), mucinous cystic neoplasms (MCNs), serous cystadenomas (SCNs), and solid pseudopapillary neoplasms (SPNs). Among these, IPMNs and MCNs are associated with a well-documented risk of malignant progression. IPMNs, in particular, are classified into main duct, branch duct, and mixed types, with varying degrees of risk depending on morphological features and histopathological grade. However, accurate prediction of malignant potential in individual lesions remains difficult in routine clinical practice, as histological confirmation is often not feasible without surgical resection. Similarly, pNETs constitute a rare but increasingly recognized group of pancreatic tumors, accounting for approximately 3% of all pancreatic malignancies. These tumors exhibit diverse biological behavior and may be functional (hormone-secreting) or non-functional. Functional tumors, such as insulinomas or gastrinomas, often present with clinical syndromes related to hormone excess, while non-functional tumors are frequently detected incidentally. Tumor grading, based on proliferative indices such as Ki-67, and tumor size are key determinants of prognosis and management. Current guidelines generally recommend surgical resection for functional tumors and for non-functional tumors ≥2 cm in size. However, the optimal management of small (≤2 cm), asymptomatic non-functional pNETs remains controversial, as many of these lesions demonstrate indolent behavior and low risk of progression. Surgical resection, including procedures such as pancreaticoduodenectomy or distal pancreatectomy, remains the standard of care for many pancreatic lesions with suspected or confirmed malignancy. However, these procedures are technically demanding and associated with considerable morbidity (20-30%) and mortality (1-3%) even in specialized centers. Postoperative complications may include pancreatic fis Покажи пълното описание...

Inclusion Criteria: * 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 * 68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases * G1 or G2 (\<5 %) histology Exclusion Criteria: * 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