Actively Recruiting
Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors
Led by Institute for Clinical and Experimental Medicine · Updated on 2026-04-17
50
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
- Capability of giving informed consent
- Pancreatic cystic neoplasm inoperability or refusal of surgery
- Branch duct IPMN with worrisome features including 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 (patients with comorbidities) risk features: CA 19-9 > 37 U/ml, increase in size > 5mm/year, dilation of main pancreatic duct between 5-10mm, size 6mm, symptoms such as new onset diabetes or acute pancreatitis
- Nodule < 5mm
- Pancreatic neuroendocrine tumor size < 2 cm
- Histological proof in non-functional lesions or histological or clinical proof in functional lesions
- 68Ga-DOTATATE PET/CT positive for pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- G1 or G2 (<5%) histology
You will not qualify if you...
- Known bleeding disorder that cannot be sufficiently corrected with medication
- Use of anticoagulants that cannot be discontinued
- Physical or psychological inability to understand the study aims and cooperate
- Pregnancy
- Inability to sign informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology
Prague, Czechia, 140 21
Actively Recruiting
Research Team
J
Jana Jarosova, MD, PhD
CONTACT
G
Gabriela Petranova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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