Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma
ConditionInsulinoma; Pancreas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-80
SponsorSahlgrenska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Insulinoma verified by pathology (often from EUS-FNB-sampling)
Disqualifiers
Patients unwilling to participate
Patients unable to understand and obtain written informed conscent
Severe comorbidity
Trial population
All patients referred to Sahlgrenska UH for the diagnosis and treatment of pancreatic insulinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EUS-RFA
Procedure/SurgeryTreatment of insulinoma by EUS-RFA
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Prospective cohort subjected to EUS-RFA1 intervention
Group B: Control group0 interventions
Trial outcomes
Primary outcomes
1
Clinical efficacy
Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)
Time frame
3-24 months post-EUSSecondary outcomes
1
Patient safety
Adverse evnt rate according to Clavien-Dindo at 30 days post-EUS-RFA
Time frame
30 days post-EUS-RFA2
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
Time frame
3-24 months post-EUS-RFA3
Imaging effect post-EUS-RFA with respect to tumor vascularization
Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of remaining tumor vascularization
Time frame
3-24 months post EUS-RFASponsors and contacts
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Source ClinicalTrials.gov