Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment Pancreatic NeuroEndocrine Neoplasms (RAPNEN)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    70
  • sponsor
    Catholic University of the Sacred Heart
Updated on 23 March 2022
insulin
fasting
endoscopic ultrasound
metastasis
dotatate
pet/ct scan
pet-ct scan
local ablation therapy
fine needle biopsy

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.

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 significant benefit in term of survival but also with significant shortand long-term adverse events.

Based on the above data, less invasive alternative therapeutic interventions to avoid shortand long-term adverse events of surgery are needed.

In this context radiofrequency ablation has been reported to be effective in the treatment of these tumors in absence of major adverse events. However, the available studies on the matter are limited by small sample size and lack of standardized criteria for patient selection.

Details
Condition Neuroendocrine Tumors, Neuroendocrine Carcinoma, Pancreas Neoplasm, Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting
Treatment EUS guided radiofrequency ablation
Clinical Study IdentifierNCT03834701
SponsorCatholic University of the Sacred Heart
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
Ga-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
Diameter between 15mm and 25mm
other distant metastases
G1 or G2 ≤ 5% on histological examination of EUS-guided biopsy samples utilizing
Absence of symptoms
EUS-FNB needles
Absence of inner calcifications

Exclusion Criteria

For all patients
Use of anticoagulants that cannot be discontinued
INR >1.5 or platelet count <50.000
Previous inclusion in other studies
Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh
frozen plasma (FFP)
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
Ga-DOTATATE PET/CT positive for lymph nodes, liver, and other distant metastasis
Previous inclusion in other studies
Diagnosis on multiple endocrine neoplasia type 1 (MEN1) syndrome or Von Hippel Lindau
syndrome
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