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

Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
Jana Jarosova, MD, PhD
jana.jarosova@ikem.cz
420261363282
Backup
Gabriela Petranova
gabriela.petranova@ikem.cz
420261365154
Time Frame
Start Date: 2026-04-11
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 50
Treatments
Experimental: EUS-guided RFA of pancreatic cystic neoplasms (PCNs)
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic cystic neoplasms in inoperable patients or patients refusing surgery
Experimental: EUS-guided RFA of solid pancreatic lesions
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic solid lesions, including PNET and other non-neuroendocrine solid lesions (e.g., metastases such as renal cell carcinoma)
Sponsors
Leads: Institute for Clinical and Experimental Medicine

This content was sourced from clinicaltrials.gov