Endoscopic Ultrasound Guided Radio Frequency Ablation Of Pancreatic Neuroendocrine Neoplasms

Study Overview

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.

N/A

Pancreatic Neuroendocrine Tumors, WHO Grade I-II

DEVICE: Radio frequency ablation

280305

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-01-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-03-29
First Submitted that Met QC Criteria 2022-02-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-03-30
First Posted (ACTUAL) 2022-02-16	Results First Posted N/A	Last Verified 2023-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Historical controls Historical controls	DEVICE: Radio frequency ablation Radio frequency ablation of pancreatic neuroendocrine tumors

Participant Group/Arm

Intervention/Treatment

OTHER: Historical controls

Historical controls

DEVICE: Radio frequency ablation

Radio frequency ablation of pancreatic neuroendocrine tumors

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Espen Thiis-Evensen, MD, PhD

Phone Number: 45039399

Email: ethiisev@ous-hf.no

Study Contact Backup

Name: Jon Sponheim, MD. PhD

Phone Number: 99029509

Email: jsponh@ous-hf.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record