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Taking people in NorwayNo phase

Tests heat-based ablation through an endoscope for pancreatic neuroendocrine tumors

Tests radiofrequency ablation, guided by endoscopic ultrasound, in adults with small pancreatic neuroendocrine tumors.

Plain-language title generated from the registry record
Registry title: Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Key facts

Where
Oslo, NorwaySee the site

Where in Norway

  • Oslo University HospitalOslo, NorwayTaking people

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Trial details

Who runs it
Oslo University Hospital
Trial code
NCT05243082
Record updated
30 March 2023
Original description
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.Read full original descriptionShow less

Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

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.

Inclusion: 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: Severe hemostasis disorders; Metastatic disease, including local lymph node metastases; Patient being managed for another malignant lesion which is progressive or under treatment; INR >1.5 or platelet count <50.00; Pregnancy; Life expectancy < 1 year; Pancreatic and/or biliary ductal dilation; Evidence of active pancreatitis; Use of anticoagulants that cannot be discontinued; Distance from the main pancreatic duct <1 mm, and placement of a pancreatic stent is not possible.

ClinicalTrials.gov NCT05243082