Clinical trial · Interventional
EUS-guided RFA for Pancreatic Neoplasms
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms
- 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)
Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.
Conditions
Conditions (1)
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 Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided RFA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS-guided RFA
- description
- EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea)
- interventionNames
- Procedure: EUS-guided RFA
Primary outcomes (1)
- measure
- Severe adverse events
- timeFrame
- 30 days
- description
- Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak, thermal injury
Secondary outcomes (6)
- measure
- Technical success rates
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years-old or above * Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (\<5cm in largest diameter) that was confirmed by fine needle aspiration cytology * Unsuitable for surgery, due to one (or more) of the following items: * ASA score \> II\* * An alternative advanced malignancy * Unsuitable for surgery upon expert's opinion for any other reason * Healthy individuals who are not keen for surgical resection * Eligible for endoscopic intervention * Written informed consent Exclusion Criteria: * Coagulopathy (international normalized ratio \>1.3, 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 (0)
Data not yet available