Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable 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.
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
Inclusion Criteria:

 -  Either gender greater than or equal to 18 years of age.

 -  Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of
 unresectability being based on 1) metastatic disease or 2) locally advanced.

 -  Biliary obstruction

 -  Blocked self expanding mesh metal stent (SEMS)

 -  Subjects capable of giving informed consent

 -  Life expectancy of at least 3 months

 Exclusion Criteria:

 -  Cardiac Pacemaker

 -  Patient unstable for endoscopy

 -  Inability to give informed consent

 -  Uncorrected coagulopathy