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RecruitingNCT05243082ERFA-PNETUpdated Mar 30, 2023

Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

An interventional study of Radio frequency ablation in Pancreatic Neuroendocrine Tumors, WHO Grade I-II, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Neuroendocrine Tumors, WHO Grade I-II
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Historical controls

    Historical controls

    Device: Radio frequency ablation

Interventions

  • DeviceRadio frequency ablation

    Radio frequency ablation of pancreatic neuroendocrine tumors

06

What researchers measure

Primary outcomes

  1. Adverse events

    To register number of patient experiencing adverse events to the radiofrequency ablation procedure

    Time frame: Up to 12 months

  2. Residual disease

    To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation

    Time frame: Up to 5 years

  3. Metastatic disease

    To register number of patient who develop of local or distant metastases

    Time frame: Up to 10 years

07

Study locations

1 of 1 sites recruiting
  • Oslo University Hospital
    Oslo, Norway
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — If requested by other investigators.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05243082
Lead sponsor
Oslo University Hospital
Collaborators
Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
Responsible party
Espen Thiis-Evensen (Senior consultant, MD, PhD, Oslo University Hospital) — Principal investigator
First posted
Feb 16, 2022
Start date
Jan 14, 2022
Primary completion
Jan 14, 2025 (estimated)
Completion
Nov 11, 2029 (estimated)
Last update
Mar 30, 2023

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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