NCT03834701Completed
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
Source: ClinicalTrials.gov · Last updated 13 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 4 Feb 2019
- Start date
- 1 Sept 2019
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- Catholic University of the Sacred Heart
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT03834701
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Sept 2019 to the primary completion date, 1 Jan 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous inclusion in other studies
- Previous inclusion in other studies
Other illness
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- Diagnosis work up negative excessive hormone secretion syndrome
- Diagnosis on multiple endocrine neoplasia type 1 (MEN1) syndrome or Von Hippel Lindau syndrome
Lab values
- INR \>1.5 or platelet count \<50.000
Other
- For all patients
- Use of anticoagulants that cannot be discontinued
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Universita' del Sacro Cuore Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.