Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (ERFA-PNET)

A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neuroendocrine Tumors, WHO Grade I-II
• Intervention / Treatment: Device: Radio frequency ablation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Espen Thiis-Evensen, MD, PhD; Phone Number: 0047 45039399; Email: ethiisev@ous-hf.no
• Study Contact Backup: Name: Jon Sponheim, MD. PhD; Phone Number: 99029509; Email: jsponh@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Espen Thiis-Evensen, MD, PhD; Phone Number: 0047 45039399; Email: ethiisev@ous-hf.no
    • Contact: Jon Sponheium, MD,PhD; Email: jsponh@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age above 18
• EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also

MEN1 patients are eligible:

• PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 <5%, or:

  • PNET < 2cm with Ki-67 <10% that has shown progression during surveillance, or:
  • PNET 1.5-2 cm with Ki-67 <10% in patients age < 60 years of age, whether progression is detected or not.
• Distance from the main pancreatic duct ≥2 mm, or <2mm with a prophylactic stent in the main pancreatic duct.
• Patient in good general condition, ECOG performance status 0-2 (see Appendix)
• Signed written informed consent

Exclusion Criteria:

• Pregnancy.
• Life expectancy < 1 year
• Severe hemostasis disorders
• Pancreatic and/or biliary ductal dilation
• Evidence of active pancreatitis
• Metastatic disease, including local lymph node metastases
• Use of anticoagulants that cannot be discontinued
• INR >1.5 or platelet count <50.00
• Distance from the main pancreatic duct <1 mm, and placement of a pancreatic stent is not possible
• Patient being managed for another malignant lesion which is progressive or under treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Historical controls	Device: Radio frequency ablation; Radio frequency ablation of pancreatic neuroendocrine tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To register number of patient experiencing adverse events to the radiofrequency ablation procedure	Up to 12 months
Residual disease	To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation	Up to 5 years
Metastatic disease	To register number of patient who develop of local or distant metastases	Up to 10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway; Haukeland University Hospital; St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Anticipated): January 14, 2025
• Study Completion (Anticipated): November 11, 2029

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: 280305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested by other investigators.
• IPD Sharing Time Frame: 2022-2030
• IPD Sharing Access Criteria: Formal collaborating contract
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No