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Recruiting NCT05243082

Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

No phase Interventional Pancreatic Neuroendocrine Tumors, WHO Grade I-II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radio frequency ablation.
Who it may be relevant to
Registry conditions: Pancreatic Neuroendocrine Tumors, WHO Grade I-II. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Radio frequency ablation
    Radio frequency ablation of pancreatic neuroendocrine tumors

Primary outcome measures

  • Adverse events [Time frame: Up to 12 months]
  • Residual disease [Time frame: Up to 5 years]
  • Metastatic disease [Time frame: Up to 10 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT05243082 · 280305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗