Title: A phase II trial of endoscopic ultrasound-guided radiofrequency ablation of cystic tumours of the pancreas(RADIOCYST)
Funder: Department of Health and Social Care

Abstract: Radiofrequency ablation Radiofrequency ablation is achieved through a high frequency alternating current which generates high temperatures causing a coagulative necrosis. It has been used widely, percutaneously and intraoperatively, to treat primary and secondary cancers in the liver, lung, kidney, bone, pancreas and oesophagus. The Habib EUS RFA catheter is a single use sterile catheter for use during endoscopic ultrasound. It is an endoscopic monopolar catheter that has been designed to ablate cystic tumours of the pancreas and has European Conformity approval for this purpose. Following identification and puncture of the pancreatic cyst, the EUS RFA catheter can be introduced through a standard 19G EUS-FNA needle. The catheter has an active metallic electrode which will be placed at the most distal part of the pancreatic cyst under EUS-guidance. The catheter can be used with a variety of commercially available RF Generators, such as the RITA 1500, RITA 1500X, or ERBE VIO200D/300D. A dose of 10W for 90 seconds will be administered to each cystic tumour. EUS-guided needle placement into pancreatic cysts is a standard technique, and will be performed by experienced (at least 5 years) endoscopists carrying out regular EUS interventions (at least 150 cases per year). Research Question To evaluate if cystic tumours of the pancreas can be safely and effectively treated through endocopic guided radiofrequency ablation. Plan of Investigation The trial is expected to begin recruitment in May 2013 and recruit 92 patients initially from three major hepatobiliary centres (UCLH and Royal Free Hospitals, Hammersmith Hosptial, Addenbrooks Hospital and the Freeman Hospital). At baseline, patients will be assessed with imaging (CT/MRI) and blood tests. After RFA, the first 42 patients will undergo CT imaging and blood tests on Day 2 following the procedure to exclude local complications of the procedure. If the procedure is found to be safe and assocated with a low complication rate, patients in the second stage of the study will be treated as a day case. If cyst ablation has not been achieved at 3 months (assessed by MRI), patients will be eligible for a further treatment of EUS-RFA. The success of cyst ablation will be formally assessed on MRI at 12 months following treatment. Potential benefits to patients Patients that have had their pancreatic cystic tumour successfully ablated will require less frequent follow up and are not expected to require pancreatic surgery. This will reduce the inconvenience and anxiety of serial imaging for patients and has potentially cost-saving advantages for the NHS.

Lay abstract: Up to 13.5% of patients that undergo an MRI scan of their abdomen without pancreatic symptoms are found to have an incidental pancreatic cyst, with the frequency increasing with age. In post-mortem series, 25% of patients have a pancreatic cyst, of which 32% are potentially premalignant and 3% malignant. Pre-malignant 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 NHS, while surgery for this usually benign condition is associated with not insignificant morbidity and mortality. Pre-malignant 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 pre-malignant 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 (EUS-RFA). If successful it will offer an alternative to long term observation or surgery for patients with this condition.

Research activity codes: 6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL