Clinical trial · Interventional
Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms
Evaluation of Safety and Feasibility of Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) for Solid Pancreatic Neoplasms
NCT03435770CI-TRIAL-00031732unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency waves under ultrasound imaging. The subject who will be recruited into this study are patients who are deemed as non-surgical candidates.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUSRA RFA needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUSRA RFA needle
- description
- This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. All patients would undergo EUS with a linear array or therapeutic echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the EUSRA RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue.
- interventionNames
- Device: EUSRA RFA needle
Primary outcomes (2)
- measure
- To measure the technical success of EUS-guided RFA
- timeFrame
- 18 months
- description
- It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle.
- measure
- To measure side effects and adverse event of EUS-guided RFA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21 years-old or above * Suffering from pancreatic neuroendocrine tumour or pancreatic ductal carcinoma that was confirmed by fine needle aspiration cytology * Unsuitable for surgery, due to one (or more) of the following items: * ASA score \>/= III * An alternative advanced malignancy * Unsuitable for surgery upon expert's opinion for any other reason * Individuals who are not keen for surgical resection * Eligible for endoscopic intervention * Written informed consent Exclusion Criteria: * Coagulopathy (international normalized ratio \>1.5, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL * Pregnancy * Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study * Patients unwilling to undergo follow-up assessments * Patients with liver cirrhosis, portal hypertension and/or gastric varices.
References
Publications (25)
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- BACKGROUNDBai H, Huangz X, Jing L, Zeng Q, Han L. The effect of radiofrequency ablation vs. liver resection on survival outcome of colorectal liver metastases (CRLM): a meta-analysis. Hepatogastroenterology. 2015 Mar-Apr;62(138):373-7. PMID 25916066
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- BACKGROUNDDe Filippo M, Bozzetti F, Martora R, Zagaria R, Ferretti S, Macarini L, Brunese L, Rotondo A, Rossi C. Radiofrequency thermal ablation of renal tumors. Radiol Med. 2014 Jul;119(7):499-511. doi: 10.1007/s11547-014-0412-1. Epub 2014 Jul 15. PMID 25024061
- BACKGROUNDSmith SL, Jennings PE. Lung radiofrequency and microwave ablation: a review of indications, techniques and post-procedural imaging appearances. Br J Radiol. 2015 Feb;88(1046):20140598. doi: 10.1259/bjr.20140598. Epub 2014 Dec 3. PMID 25465192
- BACKGROUNDLiu SY, Ng EK, Lee PS, Wong SK, Chiu PW, Mui WL, So WY, Chow FC. Radiofrequency ablation for benign aldosterone-producing adenoma: a scarless technique to an old disease. Ann Surg. 2010 Dec;252(6):1058-64. doi: 10.1097/SLA.0b013e318f66936.