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The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic ultrasound-guided radiofrequency ablation | Experimental | Endoscopic ultrasound-guided radiofrequency ablation will be performed using the "EUSRA" system (Taewoong, Seoul, Korea). The system consists of a 19-gauge needle electrode (140-cm long), a radiofrequency current generator (VIVA RF generator; Taewoong), and an inner cooling system that circulates chilled saline solution during the radiofrequency ablation procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to the radiofrequency current generator and to a cooling pump. The generator, in addition to providing radiofrequency current, allows the control of physical power and impedance parameters. |
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| Surgery | Active Comparator | Surgical resection will be performed in an inpatient setting. The type and extension of surgical resection, as well as need for lymphadenectomy, will be decided by the treating surgeons according to the tumor position, distance from the main pancreatic duct, and local expertise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound-guided radio frequency ablation | Procedure | Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | Rate of overall and severe adverse events will be recorded | Up to 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effectiveness | Rate of patients experiencing symptoms disappearance | Up to 72 months |
| Evaluation of quality of life by questionnaire | Assessment of quality of life using a questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Verona | Verona | 37138 | Italy |
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| ID | Term |
|---|---|
| D007340 | Insulinoma |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | Surgical resection of pancreatic insulinoma |
|
| Up to 72 months |
| Length of hospital stay | Days of hospitalization | Up to 72 months |
| Recurrence | Rate of local or distant recurrence | Up to 72 months |
| Reintervention | Rate of reintervention | Up to 72 months |
| Pancreatic insufficiency | Rate of endocrine or exocrine pancreatic insufficiency | Up to 72 months |
| 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 |