Sponsor: University College London
Funder: NiHR RfPB
ClinicalTrials.gov Identifier: NCT02343692
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. 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. 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. New early treatment options for premalignant tumours are urgently required.
New catheters for treating cystic tumours of the pancreas during endoscopy has been developed. Studies in animals and in a small number of patients have suggested that radiofrequency ablation is a safe and effective tool for treating a number of growths in the pancreas. The purpose of this study is to evaluate if radiofrequency ablation can be used to ablate (destroy) small cystic tumours of the pancreas (so patients do not require long-term follow up) and to collect some health economics data (assess cost of treatment).
The study will also 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.