A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tu… (NCT02343692) | Clinical Trial Compass
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A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas
Australia, United Kingdom97 participantsStarted 2016-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated.
✓. 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.
✓. ECOG performance status 0, 1 or 2.
✓. Estimated life expectancy of at least 12 weeks.
✓. Age \>18 years.
✓. Capable of giving written informed consent.
✓. 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
✕. A diagnosis of a pancreatic cystic tumour where surgical resection is indicated.
✕. Pancreatic cysts greater than 3cm or less than 0.5cm in size.
✕. Pancreatic cysts with malignant transformation.
✕. Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures.
✕. Cysts arising from the main pancreatic duct.
✕. 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).