Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cysts and small neuroendocrine tumors
Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Neuroendocrine Tumors
NA · Institute for Clinical and Experimental Medicine · NCT07536087
This study will try endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) to treat pancreatic cystic lesions and small pancreatic neuroendocrine tumors in patients who cannot or do not want surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine (other gov) |
| Drugs / interventions | radiation |
| Locations | 1 site (Prague) |
| Trial ID | NCT07536087 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with pancreatic cystic neoplasms with worrisome features or small (under 2 cm), G1–G2 pancreatic neuroendocrine tumors that are PET-positive and have no evidence of nodal or distant metastases, who are not surgical candidates or decline surgery.
Not a fit: Patients with invasive or metastatic pancreatic cancer, lesions not reachable by endoscopic ultrasound, significant coagulopathy or bleeding disorders, or those requiring standard surgical oncologic resection are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, EUS-RFA could offer a less invasive option that reduces the need for major surgery and ongoing intensive imaging surveillance for selected pancreatic lesions.
How similar studies have performed: Prior case series and small prospective cohorts of EUS-RFA for pancreatic lesions have shown promising technical success and short-term lesion control but larger randomized data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Prague
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endoscopic Ultrasound-Guided Radiofrequency Ablation, Pancreatic Neuroendocrine Tumors, Pancreatic Cystic Neoplasms, Pancreatic Cystic Neoplasm, Intraductal papillary mucinous neoplasm, EUS-guided RFA, Pancreas, Neuroendocrine tumor