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

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.

Conditions

• Endoscopic Ultrasound-Guided Radiofrequency Ablation
• Pancreatic Neuroendocrine Tumors (pNET)
• Pancreatic Cystic Neoplasms

Interventions

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. 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.

PROCEDURE

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. 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.

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine

  lead OTHER_GOV

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-11

Primary Completion

2027-12-31

Completion

2029-12-31

Countries

• Czechia

Study Locations