Clinical trial · Interventional
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study
NCT03834701CI-TRIAL-00073973RAPNENcompletedN/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)
This study evaluates the possibility and the safety of performing local therapy for Pancreatic neuroendocrine neoplasms (PanNENs) using radiofrequency ablation of the tumor under ultrasonography (EUS) guidance.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS guided radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS guided radiofrequency ablation
- description
- Radiofrequency ablation will be performed using a system that consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure.
- interventionNames
- Device: EUS guided radiofrequency ablation
Primary outcomes (1)
- measure
- Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)
- timeFrame
- 1 year
- description
- AEs will be classified as procedural when they occur during the procedure; post-procedural when they will occur up to 14 days after the procedure; late when they will occur more than 14 days after the procedure. Minor AEs will be those that need no therapy and have no sequelae (A) or have minor therapy or consequence, including overnight admission (B). Major events include those that require major therapy or hospitalization (24- 48 hours) (C); major therapy, need unplanned increase in level of care, or hospitalization \>48 hours (D); or result in permanent adverse sequelae (E) and death (F).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: For all patients * Age ≥18 years and \<80 years * Signed written informed consent * Distance from the main pancreatic duct ≥2mm * Able to undergo endoscopic ultrasound examination * Homogeneous enhancement at contrast harmonic EUS (CH-EUS) For patients with functional pancreatic neuroendocrine neoplasms (F-PanNENs), almost all insulinomas * Definitive diagnosis of a clinical syndrome related to excessive insulin secretion fasting test, insulin blood levels, C-peptide blood levels) * Single lesion visualized at CT, and/or MRI, and/or EUS * Size \< 20mm For patients with non functional pancreatic neuroendocrine neoplasms (NF-PanNENs) * EUS fine needle biopsy (FNB) proven NF-PanNENs * 68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases * Hyper- or Iso-enhancing pattern at MRI and/or CT with negative lymph nodes, liver, and other distant metastases * G1 or G2 ≤ 5% on histological examination of EUS-guided biopsy samples utilizing EUS-FNB needles * Diameter between 15mm and 25mm, * Absence of symptoms * Absence of inner calcifications Exclusion Criteria: * For all patients * Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP) * Use of anticoagulants that cannot be discontinued * INR \>1.5 or platelet count \<50.000 * Previous inclusion in other studies * Pregnancy * Minimal distance from the main pancreatic duct \<1mm * Inability to sign the informed consent * Heterogeneous enhancement at contrast harmonic EUS (CH-EUS) For patients with F-PanNENs (almost all insulinomas) * Diagnosis work up negative excessive hormone secretion syndrome * Multiple lesions visualized at CT, and/or MRI, and/or EUS * Size \> 20mm * For patients with NF-PanNENs * G2\>5% or G3 on histological examination of EUS-guided biopsy samples * Diameter \<15 mm and \>25 mm * Presence of symptoms * Presence of calcifications * Hypo-enhancing pattern at MRI and/or CT * 68Ga-DOTATATE PET/CT positive for lymph nodes, liver, and other distant metastasis * Diagnosis on multiple endocrine neoplasia type 1 (MEN1) syndrome or Von Hippel Lindau syndrome * Previous inclusion in other studies
References
Publications (1)
- DERIVEDHofland J, de Herder WW, Kann PH. Turning Up the Heat: Endoscopic Ablation of Pancreatic Neuroendocrine Neoplasms. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5053-5055. doi: 10.1210/jc.2019-00954. No abstract available. PMID 31058975