The ID-RFA Trial
Research type
Research Study
Full title
A pilot multicentre prospective randomised controlled trial comparing the safety and efficacy of intraductal radio-frequency ablation (ID-RFA) using Starmed’s temperature controlled ELRA™ probe plus biliary stenting versus biliary stenting alone for the treatment of malignant biliary obstruction.
IRAS ID
274029
Contact name
Clare Bent
Contact email
Sponsor organisation
University Hospitals Dorset NHS Foundation Trust.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Liver, pancreas and gallbladder cancers can block the bile duct, causing a build-up of toxins known as ‘jaundice’. Where surgery to remove the cancer is not possible, maintaining flow through the bile duct is a significant factor in patients’ length and quality of life. Jaundice itself can be fatal, and must be controlled before patients can receive chemotherapy. Current standard treatment for such patients is placement of a small mesh tube (stent) where the bile duct is narrowed to keep it open. However these stents often become blocked by cancer growing into and over it, and build-up of ‘sludge’ from the gall bladder. This may require further stent placement, however it may not be safe to do so at this point.
Intraductal radiofrequency ablation uses heat energy to burn the cancer tissue before stent placement to try and slow its growth into the bile duct and over the stent, and to clear blocked stents. Existing evidence suggests this increases the time before stents become blocked. However, long term data within the NHS setting is lacking. As a fully powered trial is not currently feasible, this pilot study is to be conducted to test and optimise the design of such.
Patients attending with malignant biliary obstruction will be recruited through the standard clinical pathway over a period of 12 months, and randomly assigned in a 1:1 ratio to receive either intraductal radiofrequency ablation with stent placement or stent placement only. Participants will be monitored for up to 12 months for survival, stent blockage, symptoms, resource use, quality of life and adverse reactions.
The study will be conducted between Royal Bournemouth Hospital and The Christie, both cancer care centres experienced in the management of these conditions, stent placement and radiofrequency ablation.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0168
Date of REC Opinion
31 Aug 2021
REC opinion
Further Information Favourable Opinion