Pancreatic Cancer Clinical Trial
Official title:
A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.
Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct
cancers, and its development can hinder the use of chemotherapy, decrease patient quality of
life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction,
endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs)
have been shown to result in a longer patency times as compared with plastic stents. However,
despite improvements in materials and stent design, stent obstruction still occurs in 13% to
44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.
Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described
in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction.
The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of
the bile duct lumen. The procedure has the potential of reducing the rate of stent
obstruction after SEMS and also prolonging survival. The safety profile appears to be
comparable that of placement of SEMS alone without added complications (<10%). The aim of the
current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in
a randomized controlled trial.We hypothesize that the application of EBRFA can reduce
recurrent biliary obstruction after SEMS.
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