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Trial record 1 of 1 for:    Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (ERFA-PNET)
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Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (ERFA-PNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05243082
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : February 16, 2022
Sponsor:
Collaborators:
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Espen Thiis-Evensen, Oslo University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors, WHO Grade I-II Device: Radio frequency ablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : January 14, 2025
Estimated Study Completion Date : November 11, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Historical controls
Historical controls
 Device: Radio frequency ablation
Radio frequency ablation of pancreatic neuroendocrine tumors


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 12 months ]
    To register number of patient experiencing adverse events to the radiofrequency ablation procedure

  2. Residual disease [ Time Frame: Up to 5 years ]
    To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation

  3. Metastatic disease [ Time Frame: Up to 10 years ]
    To register number of patient who develop of local or distant metastases


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT05243082


Contacts
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Contact: Espen Thiis-Evensen, MD, PhD 45039399 ext 0047 ethiisev@ous-hf.no
Contact: Jon Sponheim, MD. PhD 99029509 jsponh@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Espen Thiis-Evensen, MD, PhD    45039399 ext 0047    ethiisev@ous-hf.no   
Contact: Jon Sponheium, MD,PhD       jsponh@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
More Information
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Responsible Party: Espen Thiis-Evensen, Senior consultant, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05243082    
Other Study ID Numbers: 280305
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If requested by other investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2022-2030
Access Criteria: Formal collaborating contract

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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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Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue