Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Espen Thiis-Evensen, MD, PhD
ethiisev@ous-hf.no
45039399
Backup
Jon Sponheim, MD. PhD
jsponh@ous-hf.no
99029509
Time Frame
Start Date: 2022-01-14
Estimated Completion Date: 2029-11-11
Participants
Target number of participants: 20
Treatments
Other: Historical controls
Historical controls
Sponsors
Collaborators: University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov