Trial Information

Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or
pancreatic cancer are suitable for surgical resection. 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. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP
(endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent
placement is the standard medical procedure for people with bile duct and pancreatic cancer.

The purpose of this study is to assess safety and ability of the endoscopic bipolar
radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of
cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat
the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes
coagulated and this may delay tumour growth and the time before the stent lumen becomes
blocked. Thereby, allowing increased periods between the need for intervention and further
stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open
longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

The objectives are:

• To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency
catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic
cancer