Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

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Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05243082
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Arms & Interventions

Arms

Other: Historical controls

Historical controls

Interventions

Device: - Radio frequency ablation

Radio frequency ablation of pancreatic neuroendocrine tumors

Contact a Trial Team

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