Trial Information

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As
the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from
the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde
cholangiopancreatography) is often prescribed during which a tube with a tiny camera
attached is inserted through the subject's mouth and advanced to a place in the small
intestine where the bile duct empties. Through this scope the doctor enlarges the ducts
with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts
open so they can drain properly. However, due to the cancer, the stents are blocked
eventually.

The purpose of this registry is to record information and evaluate the impact of
radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in
improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in
the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to
heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes
coagulated and this may delay tumor growth and the time before the stent lumen becomes
blocked. Thereby, allowing increased periods between the need for intervention and further
stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures
conducted for pancreatico-biliary disorders.

The safety and efficacy of various radio frequency ablation probes have been assessed in a
series of studies. This multi-center registry has been initiated:

1. To document the immediate and post procedure clinical performance of radio frequency
ablation in a 'real world' patient population requiring stent implantation for
pancreaticobiliary disorders.

2. To assess the immediate and 6 months post procedure adverse event rate in patients.

3. To assess the impact of RFA on the life expectancy of patients suffering from
pancreaticobiliary malignancies.