Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

NCT05243082 | Recruiting DMC

• 1 other identifier: 280305
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Outcome Measures

Primary Outcomes (3)

• Adverse events

  To register number of patient experiencing adverse events to the radiofrequency ablation procedure

  Up to 12 months

• Residual disease

  To register number of patient who develop residual disease in the area of the tumor that has been treated with radiofrequency ablation

  Up to 5 years

• Metastatic disease

  To register number of patient who develop of local or distant metastases

  Up to 10 years

Study Arms (1)

Historical controls

OTHER

Historical controls

Device: Radio frequency ablation

Interventions

Radio frequency ablation DEVICE

Radio frequency ablation of pancreatic neuroendocrine tumors

Historical controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Espen Thiis-Evensen, MD, PhD

CONTACT

45039399; ethiisev@ous-hf.no

Jon Sponheim, MD. PhD

CONTACT

99029509; jsponh@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, MD, PhD

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 16, 2022
• Study Start: January 14, 2022
• Primary Completion: January 14, 2025
• Study Completion (Estimated): November 11, 2029
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2022-2030
• Access Criteria: Formal collaborating contract

Locations

NO (1)