Insulinoma; PancreasEURAGILNCT07272187
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions
An observational study of Insulinoma; Pancreas and MEN1, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulinoma; Pancreas, MEN1, NETs
- What is being tested?
- observational study
- How many people
- 138 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to 31 Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the above inclusion criteria will be offered participation. Herlev Hospital has a national function, and therefore patients from all regions of Denmark are included.
Who may be able to join
- Patients with one or more lesions amendable to undergo EUS-RFA
- Insulinomas ≤ 25 mm confirmed by a 72-h fasting test, cross-sectional scanning, and a biopsy with low Ki67 index (<10%)
- Non-functional pNEN lesions between 10-20 mm and growing, confirmed by a biopsy with low Ki67 index (<10%), or larger pNEN lesions in patients who are not candidates for surgical treatment
- Unilateral APA with benign characteristics on non-contrast enhanced CT located in the left adrenal and confirmed lateralization on AVS
- Adult habile patients
- Signed informed consent
Who cannot join
- Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
- Uncorrected coagulopathy (INR >1.8 or thrombocyte count < 50 mia/L)
- Pregnancy
- Metastatic malignancy with expected remaining life expectancy < 3 years
- Stenosis in upper GI tract or altered anatomy (e.g. previous gastrectomy) preventing the passage of an echoendoscope
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev og Gentofte Hospital
Herlev, Capital Region, 2730
Bojan Kovacevic, MD, ph.d., 0045 38686312, bojan.kovacevic@regionh.dk
About this study
Official title: Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study
The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA.
Primary Objectives:
Read more
- Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time.
- Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires.
Secondary Objectives:
- Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure.
- Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed.
Exploratory Objectives:
- To identify factors associated with adverse events and factors related to clinical success or lack there of.
The study is observational. All participant will receive EUS-RFA as part of their standard clinical care.
Participants will:
- Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue.
- Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment.
- Complete validated questionnaires about satisfaction and quality of life.
The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes.
This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.
- Conditions
- Insulinoma; Pancreas, MEN1, NETs, Radiofrequency Ablation, Endoscopic Ultrasound (EUS), Conn Syndrome
- Being tested
- observational study
- Medical subject headings
- Insulinoma, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Observational study. Patients recieve standard clinical care with routine follow up
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing EUS-RFA | The cohort consists of patients with benign pancreatic or adrenal tumors (patients with pNENs, MEN1 and Conns syndrome) Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction measured through validated questionarie SF-36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable state
Measured: From enrollment and 5 years forward
Clinical efficacy
Proportion of included patients with documented biochemical response and symptom improvement, or lesion size decrement/cessation of growth in case of MEN1 patients
Measured: From enrollment and 5 years forward
Secondary outcomes (2)
Adverse events
Proportion of treated patients experiencing AEs as defined by AGREE classification during a 30-day period following the procedure
Measured: From enrollment and 5 years forward
Technical success
Proportion of included patients where EUS-RFA was technically feasible
Measured: From enrollment and 5 years forward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Nov 2025
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulinoma; PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Kovacevic, Herlev Hospital
- Investigators
- Bojan Kovacevic, MD, ph.d., Principal investigator, Herlev and Gentofte Hospital, Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272187
- Sponsor's protocol ID
- p-2025-19131
- Acronym
- EURAGIL
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study
- ClinicalTrials.gov ID
- NCT07272187
- Acronym / sponsor ID
- EURAGIL / p-2025-19131
- Conditions
- Insulinoma; Pancreas, MEN1, NETs, Radiofrequency Ablation, Endoscopic Ultrasound (EUS), Conn Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA.
Primary Objectives:
- Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time.
- Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires.
Secondary Objectives:
- Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure.
- Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed.
Exploratory Objectives:
- To identify factors associated with adverse events and factors related to clinical success or lack there of.
The study is observational. All participant will receive EUS-RFA as part of their standard clinical care.
Participants will:
- Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue.
- Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment.
- Complete validated questionnaires about satisfaction and quality of life.
The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes.
This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing EUS-RFA | – | Other: observational studyThe cohort consists of patients with benign pancreatic or adrenal tumors (patients with pNENs, MEN1 and Conns syndrome) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the above inclusion criteria will be offered participation. Herlev Hospital has a national function, and therefore patients from all regions of Denmark are included.
Key inclusion criteria (6 listed)
- Patients with one or more lesions amendable to undergo EUS-RFA
Key exclusion criteria (5 listed)
- Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyObservational study. Patients recieve standard clinical care with routine follow up | Other | Patients undergoing EUS-RFA |
Primary outcome
Patient satisfaction
Time frame: From enrollment and 5 years forward
Patient satisfaction measured through validated questionarie SF-36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable state
Clinical efficacy
Time frame: From enrollment and 5 years forward
Proportion of included patients with documented biochemical response and symptom improvement, or lesion size decrement/cessation of growth in case of MEN1 patients
2 secondary outcomes
Adverse events
Time frame: From enrollment and 5 years forward
Technical success
Time frame: From enrollment and 5 years forward
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bojan Kovacevic, MD, ph.d. principal investigator
Herlev and Gentofte Hospital, Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulinoma; Pancreas and MEN1, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bojan Kovacevic, ph.d., MD (0045 3868 6312, bojan.kovacevic@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: From enrollment and 5 years forward). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.