Clinical trial · Interventional
A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas
A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas (RADIOCYST01)
- 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)
Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their abdomen without pancreatic symptoms are found to have an incidental pancreatic cyst, with the frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are currently either observed or removed surgically according to international guidelines. Observation is associated with significant anxiety for patients and a growing cost to the National Health Service, while surgery for this usually benign condition is associated with not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for a number of years before malignant transformation, creating a window of opportunity for minimally invasive intervention and cure. New early treatment options for premalignant tumours are urgently required. This study will evaluate the safety and efficacy of a novel minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic ultrasound guided radiofrequency ablation (EUSRFA). If successful it will offer an alternative to long term observation or surgery for patients with this condition.
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 Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS guided RFA of cystic tumours of the pancreas | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency abalation
- description
- Intervention: Endoscopic Ultrasound (EUS) guided radiofrequency ablation (RFA) of cystic tumours of the pancreas Device: An RFA generator (ERBE VIO 300D, Dolby medical products, Scotland) Procedure: Delivery of sequential doses of electrical energy at 10W for a total of up to 4 minutes 30 seconds (3 x 90 second applications) to ablate the cystic lesion. Ablation of cystic tumours of the pancreas
- interventionNames
- Procedure: EUS guided RFA of cystic tumours of the pancreas
Primary outcomes (1)
- measure
- Presence of pancreatic cyst
- timeFrame
- One year
- description
- To evaluate pancreatic cyst ablation at 12 months following EUSguided radiofrequency ablation therapy in patients with pre-diagnosed cystic tumours of the pancreas.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated. 2. Pancreatic cystic tumour between 0.5 and 3cm in size. Cysts greater than 3cm or with mural nodules can be included only if patients are unsuitable for surgical resection. 3. ECOG performance status 0, 1 or 2. 4. Estimated life expectancy of at least 12 weeks. 5. Age \>18 years. 6. Capable of giving written informed consent. 7. Women of child-bearing potential must have a negative pregnancy test (qualitative serum hCG) in the week before treatment, AND be using an adequate contraception method, which must be continued for at least 1 week after RF. Exclusion Criteria: 1. A diagnosis of a pancreatic cystic tumour where surgical resection is indicated. 2. Pancreatic cysts greater than 3cm or less than 0.5cm in size. 3. Benign pancreatic cysts (e.g. pseudocyst). 4. Serous cystadenomas. 5. Pancreatic cysts with malignant transformation. 6. Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures. 7. Cysts arising from the main pancreatic duct. 8. History of active or prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously). 9. Acute pancreatitis within the previous 4 weeks. 10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial. 11. Any psychiatric disorder making reliable informed consent impossible. 12. Pregnancy or breast-feeding. 13. ECOG performance status 3 or 4
References
Publications (0)
Data not yet available