Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
RFA is well established method for treatment of some solid tumors, like liver cancer, lung
cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP
catheter, was approved for clinical use. It uses bipolar electrical energy for tissue
coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography
(ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit
for controlling tumour growth. Several cohort studies have been published and the
feasibility and safety of such technique has been proved.
The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to
compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in
patients with unresectable cholangiocarcinoma or ampullary carcinoma.
The objectives are
- To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients'
survival as compared to the only stenting therapy.
- To assess the impact of RFA on the stent's patency.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Bing Hu, MD, PhD
Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
China: Science and Technology Commission of Shanghai Municipality
EHBH B-RFA 2013-001