Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cysts and small neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional protocol uses endoscopic ultrasound to place a radiofrequency ablation probe directly into pancreatic cystic neoplasms and small pancreatic neuroendocrine tumors in patients deemed inoperable or who refuse surgery. Eligible pancreatic cysts include branch-duct IPMNs with worrisome features and other cystic lesions meeting size or risk criteria, while eligible pNETs are small (under 2 cm), G1–G2, and PET-positive without distant metastases. The primary aim is to test the technical feasibility and effectiveness of EUS-RFA in reducing lesion size or eliminating viable tumor tissue, with secondary monitoring of safety and adverse events. Follow-up includes imaging and clinical assessment to document response, complications, and need for further intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Jana Jarosova, MD, PhD
• Email: jana.jarosova@ikem.cz
• Phone: 420261363282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.