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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:
Secondary Objectives:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing EUS-RFA | The cohort consists of patients with benign pancreatic or adrenal tumors (patients with pNENs, MEN1 and Conns syndrome) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | Observational study. Patients recieve standard clinical care with routine follow up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From enrollment and 5 years forward |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Proportion of treated patients experiencing AEs as defined by AGREE classification during a 30-day period following the procedure | From enrollment and 5 years forward |
| Technical success |
| Measure | Description | Time Frame |
|---|---|---|
| Factors associated with adverse events | Factors associated with adverse events | From enrollment and 5 years forward |
| Factors associated with clinical success or failure | Factors associated with clinical success or failure |
Inclusion Criteria:
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
Exclusion Criteria:
Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojan Kovacevic, ph.d., MD | Contact | 0045 3868 6312 | bojan.kovacevic@regionh.dk | |
| Louise Maegaard, MSc, RN | Contact | 0045 38689879 | louise.maegaard@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bojan Kovacevic, MD, ph.d. | Herlev and Gentofte Hospital, Capital Region of Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev og Gentofte Hospital | Recruiting | Herlev | Capital Region | 2730 | Denmark |
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| ID | Term |
|---|---|
| D007340 | Insulinoma |
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Proportion of included patients where EUS-RFA was technically feasible
| From enrollment and 5 years forward |
| From enrollment and 5 years forward |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |