Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma | NCT07585032

Studies
Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

NCT07585032

Sponsor

Sahlgrenska University Hospital

Status

Recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Insulinoma; Pancreas

Interventions

EUS-RFA

Countries

Sweden

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

May 2026

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

Mar 31, 2025Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Jun 2029Estimated

First Submitted Date

Apr 27, 2026

First Submission Date that Met QC Criteria

May 8, 2026

First Posted Date

May 13, 2026Actual

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

May 8, 2026

Last Update Posted Date

May 13, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Per Hedenström, Senior Consultant, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

Transcutaneous and EUS-guided radiofrequency ablation are both modern modalities to apply in the managemnet of various malignancies.

In the current study the investigators aim to study the technical feasibility, patient safety and clinical efficacy of EUS-RFA for the treatment of pancreatic insulinoma.

Detailed Description

Patients (P): Alla patients referred to Sahlgrenska University Hospital for the diagnostic work-up and management of a suspected pancreatic insulinoma.

Intervention (I): EUS-RFA

Control group (C): Patients with insulinoma treated with conventional surgery during the time frame 2018-2025 (historic controls).

Outcome (O):

Technical feasibility
Patient safety
Clinical efficacy (follow-up with biochemistry and imaging at 3, 6, 12, and 24 months post-EUS-RFA).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective cohort subjected to EUS-RFA		All patientens enrolled prospectively from 2025 and onwards subjected to EUS-RFA as treatemtn for pancreatic insulinoma	Procedure: EUS-RFA
Control group		All patients subjected to surgery due to insulinoma during 2018-2024 acting as a historic control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS-RFA	Procedure	Treatment of insulinoma by EUS-RFA	Prospective cohort subjected to EUS-RFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical efficacy	Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)	3-24 months post-EUS

Secondary Outcomes

Measure	Description	Time Frame
Patient safety	Adverse evnt rate according to Clavien-Dindo at 30 days post-EUS-RFA	30 days post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor size	Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of tumor size

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Insulinoma verified by pathology (often from EUS-FNB-sampling)

Exclusion Criteria:

Patients unwilling to participate
Patients unable to understand and obtain written informed conscent
Severe comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients referred to Sahlgrenska UH for the diagnosis and treatment of pancreatic insulinoma.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Per Hedenström, Associate Professor	Contact	+46 31 3421000		per.hedenstrom@vgregion.se
Riadh Sadik, Associate Professor	Contact	+46 31 3421000

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska Univeristy Hospital	Recruiting	Gothenburg			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007340	Insulinoma

Ancestor Terms

ID	Term
D007516	Adenoma, Islet Cell
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

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Browse Branches

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