Effect of endoscopic ultrasound-guided radiofrequency ablation, on overall survival, in patients with locally advanced pancreatic adenocarcinoma: a multicenter randomized controlled clinical trial

Abstract

Background: Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumor (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients Importance: There is an urgent need for new therapeutical options in pancreatic adenocarcinoma. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours such as liver and lung neoplasms. RFA produces local tumour destruction from an electrode implanted directly into the tumour causing frictional heating. Objective: To evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUSRFA) plus conventional treatment (chemotherapy ± radiotherapy) improves overall survival in patients with non-resectable locally advanced pancreatic adenocarcinoma in comparison to protocolised treatment. The overall survival will be analysed 2 and 5 years after finishing the treatment. It will be also determined the safety of the procedure. So, complications after the intervention will be registered. Moreover, a pain score, length of hospital stay, type of chemotherapy received, radiotherapy, and progression free survival will be determined. Design: A multicenter open-labelled randomized interventional clinical trial will be carried out. Patients with pancreatic cancer, confirmed anatomopathologically, will be introduced into the study performed in universitary centers such as: Dr. Josep Trueta Hospital, Vall d’Hebron Hospital, Bellvitge Hospital and Hospital Clinic of Barcelona. Methods: A total of 274 patients are needed to complete the study. Group A (137 patients), will be treated with chemotherapy ± radiotherapy (QT±RT). Group B (137) EUS-RFA will be performed before starting the protocolised treatment (QT±RT). For this procedure, it will be necessary the Habib TM catheter, a monopolar radiofrequency system, connected to a generator. Also, a linear ecoendoscope will be used to guide the intervention and visualize the surrounding anatomy. Participants: Patients with non-metastatic locally advanced pancreatic cancer confirmed by citology or biopsy without previous treatment and performance status between 0-2