Clinical trial · Interventional
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
NCT05243082CI-TRIAL-00065192ERFA-PNETrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumors, WHO Grade I-II | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radio frequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Historical controls
- description
- Historical controls
- interventionNames
- Device: Radio frequency ablation
Primary outcomes (3)
- measure
- Adverse events
- timeFrame
- Up to 12 months
- description
- To register number of patient experiencing adverse events to the radiofrequency ablation procedure
- measure
- Residual disease
- timeFrame
- Up to 5 years
- description
- To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age above 18 * EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also MEN1 patients are eligible: * PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 \<5%, or: * PNET \< 2cm with Ki-67 \<10% that has shown progression during surveillance, or: * PNET 1.5-2 cm with Ki-67 \<10% in patients age \< 60 years of age, whether progression is detected or not. * Distance from the main pancreatic duct ≥2 mm, or \<2mm with a prophylactic stent in the main pancreatic duct. * Patient in good general condition, ECOG performance status 0-2 (see Appendix) * Signed written informed consent Exclusion Criteria: * Pregnancy. * Life expectancy \< 1 year * Severe hemostasis disorders * Pancreatic and/or biliary ductal dilation * Evidence of active pancreatitis * Metastatic disease, including local lymph node metastases * Use of anticoagulants that cannot be discontinued * INR \>1.5 or platelet count \<50.00 * Distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible * Patient being managed for another malignant lesion which is progressive or under treatment
References
Publications (0)
Data not yet available
No reference posted for this study.