Endoscopic Ultrasound Guided Radio Frequency Ablation of... | NCT05243082

Studies
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

NCT05243082

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

Mar 30, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Interventions

Radio frequency ablation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2022Actual

Primary Completion Date

Jan 14, 2025Estimated

Completion Date

Nov 11, 2029Estimated

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Feb 7, 2022

First Posted Date

Feb 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
Haukeland University Hospital	OTHER
St. Olavs Hospital	OTHER
University Hospital of North Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Historical controls	Other	Historical controls	Device: Radio frequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radio frequency ablation	Device	Radio frequency ablation of pancreatic neuroendocrine tumors	Historical controls

Outcomes Module

Primary Outcomes

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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Espen Thiis-Evensen, MD, PhD	Contact	45039399	0047	ethiisev@ous-hf.no
Jon Sponheim, MD. PhD	Contact	99029509		jsponh@ous-hf.no

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo			Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

If requested by other investigators.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

2022-2030

Access Criteria

Formal collaborating contract

URL

Not provided

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative