Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms (ERFA-PNET)
Primary Purpose
Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Radio frequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neuroendocrine Tumors, WHO Grade I-II
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
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Historical controls
Arm Description
Historical controls
Outcomes
Primary Outcome Measures
Adverse events
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Residual disease
To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation
Metastatic disease
To register number of patient who develop of local or distant metastases
Secondary Outcome Measures
Full Information
NCT ID
NCT05243082
First Posted
January 14, 2022
Last Updated
March 29, 2023
Sponsor
Oslo University Hospital
Collaborators
Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT05243082
Brief Title
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Acronym
ERFA-PNET
Official Title
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
January 14, 2025 (Anticipated)
Study Completion Date
November 11, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neuroendocrine Tumors, WHO Grade I-II
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Historical controls
Arm Type
Other
Arm Description
Historical controls
Intervention Type
Device
Intervention Name(s)
Radio frequency ablation
Intervention Description
Radio frequency ablation of pancreatic neuroendocrine tumors
Primary Outcome Measure Information:
Title
Adverse events
Description
To register number of patient experiencing adverse events to the radiofrequency ablation procedure
Time Frame
Up to 12 months
Title
Residual disease
Description
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
Title
Metastatic disease
Description
To register number of patient who develop of local or distant metastases
Time Frame
Up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Espen Thiis-Evensen, MD, PhD
Phone
45039399
Ext
0047
Email
ethiisev@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jon Sponheim, MD. PhD
Phone
99029509
Email
jsponh@ous-hf.no
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Espen Thiis-Evensen, MD, PhD
Phone
45039399
Ext
0047
Email
ethiisev@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Jon Sponheium, MD,PhD
Email
jsponh@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
If requested by other investigators.
IPD Sharing Time Frame
2022-2030
IPD Sharing Access Criteria
Formal collaborating contract
Learn more about this trial
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
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