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

NCT03834701 | Completed

• 1 other identifier: RAPNEN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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) guidance.

Conditions

Neuroendocrine Tumors; Neuroendocrine Carcinoma; Pancreas Neoplasm; Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA)

  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).

  1 year

Secondary Outcomes (1)

• Rates of secondary surgery

  1 year

Study Arms (1)

EUS guided radiofrequency ablation

EXPERIMENTAL

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.

Device: EUS guided radiofrequency ablation

Interventions

EUS guided radiofrequency ablation DEVICE

The EUS-RFA system (Taewoong, Seoul, Korea) utilized for EUS-RFA 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. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to a radio frequency current generator (VIVA RF generator; Taewoong) and to a cooling pump. The generator, in addition to providing radio frequency current, allows the control of physical power and impedance parameters.

EUS guided radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 other distant metastases
• G1 or G2 ≤ 5% on histological examination of EUS-guided biopsy samples utilizing EUS-FNB needles

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (2)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

Location

Universita' del Sacro Cuore

Rome, 00136, Italy

Location

Related Publications (1)

• Hofland 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 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alberto Larghi, PhD

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

IT (2)