To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
3 EUS-RFA interventions at 1-month interval
Standard intervention
Centre de recherche du Centre hospitalier de l'université de Montréal
Montreal, Quebec, Canada
Survival
Duration of survival
Time frame: 1 month
Survival
Duration of survival
Time frame: at time of death on average 10months
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Quality of life questionnaire DDQ15
Time frame: 1 month
Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
Quality of life questionnaire DDQ15
Time frame: Time of death on average 10 months
Pain reduction
Likert Scale
Time frame: 1 month
Pain reduction
Likert Scale
Time frame: Time of death on average 10months
Tumour Size
Measures during follow-upEUS
Time frame: 4 months
Monitoring of Adverse reactions
Number of participants with treatment-related adverse events will be recorded
Time frame: At time of death on average 10months
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