Clinical trial · Interventional
Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms. Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard treatment of solid or cystic pancreatic lesions with malignant potential has been surgical resection, with lesions in the pancreatic head requiring a Whipple resection whereas pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry significant morbidity and mortality. The study would like to outline the feasibility, safety, adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation (RFA) in pancreatic neoplasms.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystic Neoplasms | Cystic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic ultrasound - radiofrequency ablation (EUS-RFA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS-RFA
- description
- monopolar radiofrequency probe (1.2 mm Habib endoscopic ultrasound - radiofrequency ablation (EUS-RFA) catheter) and 19 or 22 gauge fine needle aspiration (FNA) needle
- interventionNames
- Device: endoscopic ultrasound - radiofrequency ablation (EUS-RFA)
Primary outcomes (1)
- measure
- To evaluate pancreatic tumor ablation effect
- timeFrame
- up to one year
- description
- Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)
Secondary outcomes (4)
- measure
- Symptom and adverse event monitoring
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Cystic neoplasms in pancreatic parenchyma or outer portion of the pancreas are defined by radiologists who evaluate the images more than twice in three months. The size of benign cystic neoplasm is between 0.5-3 cm. Or surgical specialist physician considers the benign tumor that larger than 3 cm is not suitable for surgery or patients unwilling to accept surgery. 2. Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score ≤ 3. 3. Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)- international normalized ratio (INR) ≦ 1.5. 4. Prior Informed Consent Form. 5. Life expectancy of at least 3 months. Exclusion Criteria: * Patients presenting with any of the following will not be enrolled into this study: 1. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception. 2. To participate in any related tumor therapy clinical trials within thirty days prior to surgery. 3. Any active metal implanted device (eg Pacemaker) 4. Patients who have other malignancies and have not been cured within five years. 5. Patients with resectable pancreatic cancer. 6. Simple pancreatic cysts (including pseudocysts) or serous cystadenoma. 7. Cystic part of the tumor is close to blood vessels or bile duct (\<0.5 cm) that might injury the related structure. 8. Cystic pancreatic tumors originate from or associate the pancreatic ducts. 9. Have acute pancreatitis in the past four weeks 10. Known history of human immunodeficiency virus (HIV) infection 11. Have cardiovascular diseases (such as acute myocardial infarction, or stroke) within the last three months 12. Moderate to severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) \<60) 13. Have any serious or poor control of systemic disease that are not suitable for this test and followup
References
Publications (0)
Data not yet available