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

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ClinicalTrials.gov Identifier: NCT03834701
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Neuroendocrine Carcinoma Pancreas Neoplasm Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting Device: EUS guided radiofrequency ablation Not Applicable

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

Based on the above data, less invasive alternative therapeutic interventions to avoid short- and 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and Non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Experimental: EUS guided radiofrequency ablation
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
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.




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) after EUS-guided radiofrequency ablation (RFA) [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Rates of secondary surgery [ Time Frame: 1 year ]
    Number of patients who will require secondary surgey due to adverse events occurence, no response/failed or partial/recurrence outcome to the RFA treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834701


Contacts
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Contact: Alberto Larghi, PhD +390630156580 alberto.larghi@yahoo.it
Contact: Carolina Gualtieri +390630156580

Locations
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Italy
Fondazione Policlinico Universitario Agostino Gemelli Not yet recruiting
Roma, RM, Italy, 00168
Contact: Carolina Gualtieri    00390630156580    carolina.gualtieri@policlinicogemelli.it   
Universita' del Sacro Cuore Not yet recruiting
Rome, Italy, 00136
Contact: Alberto Larghi, MD    +390630156580    albertolarghi@yahoo.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Alberto Larghi, PhD Fondazione Policlinico Universitario Agostino Gemelli

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Responsible Party: Guido Costamagna, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03834701     History of Changes
Other Study ID Numbers: RAPNEN
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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