Status:
COMPLETED
Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Neuroendocrine Tumors
Neuroendocrine Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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)...
Detailed Description
Pancreatic neuroendocrine neoplasms (PanNENs) are rare, but their incidence has significantly increased in the last decades. The mainstay treatment of PanNENs is surgery, which is associated with a si...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03834701
Start Date
September 1 2019
End Date
February 1 2024
Last Update
February 13 2024
Active Locations (2)
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1
Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, Italy, 00168
2
Universita' del Sacro Cuore
Rome, Italy, 00136