Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine … (NCT03834701) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
Italy60 participantsStarted 2019-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 si…
What they're measuring
1
Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)