ARDEO trial
Research type
Research Study
Full title
A phase II prospective randomised clinical study of endoscopic ultrasound-guided radiofrequency ablation for inoperable pancreatic ductal adenocarcinoma
IRAS ID
200303
Contact name
Mikael Sodergren
Contact email
Sponsor organisation
Joint Research Compliance Office
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Patients with pancreatic cancer have a very poor prognosis (5% survival at 5 years) and often present late when surgery is no longer an option. Radiofrequency has been in routine use in medicine for several decades and recent clinical research has shown that when delivered using endoscopic ultrasound for bile duct cancers, it is associated with significantly improved survival. Radiofrequecy ablation in locally advanced pancreatic cancer performed as part of an operation has been associated with an improved prognosis compared with those who are treated with chemotherapy only. Recent research has suggested that an up regulation of the immune system is the mechanism by which radiofrequency ablation improved prognosis. This randomised phase II study is designed to determine if treating the tumour with radiofrequency ablation under endoscopic ultrasound can improve the survival of patients with inoperable pancreatic cancer. The device is delivered to the tumour via an endoscope (a tube through the mouth) and is connected to a standard radiofrequency generator set to deliver a very small amount of power, but sufficient to kill cancer cells with heat. Patients enrolled in the study will be randomised to one of two groups; the treatment group receive endoscopic ultrasound-guided radiofrequency ablations (EUS-RFA) to the cancer once a month for up to three months. Both treatment and control groups will receive standard of care gemcitabine chemotherapy.
REC name
South West - Frenchay Research Ethics Committee
REC reference
18/SW/0103
Date of REC Opinion
31 May 2018
REC opinion
Further Information Favourable Opinion