Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Not Applicable

Recruiting

• Conditions: Pancreatic Neuroendocrine Tumors, WHO Grade I-II
• Interventions: Device: Radio frequency ablation

• Registration Number: NCT05243082
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-14
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2025-01-14
• Study Completion: 2029-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Historical controls	Radio frequency ablation	Historical controls

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 12 months	To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Residual disease	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
Metastatic disease	Up to 10 years	To register number of patient who develop of local or distant metastases

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway