Brief Title
Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
Official Title
Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
Brief Summary
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.
Detailed Description
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
Study Type
Interventional
Primary Outcome
Change From Baseline in Bile Duct Stricture Diameter
Secondary Outcome
Number of Participants With Adverse Events
Condition
Cholangiocarcinoma
Intervention
Endoscopic bipolar radiofrequency probe (ENDOHPB)
Study Arms / Comparison Groups
Radiofrequency probe (ENDOHPB)
Description: Intervention: The EndoHPB is an endoscopic bipolar catheter designed to ablate tissue in malignant tumors within luminal structures, such as the biliary tree or pancreatic ducts. EndoHPB can be deployed via an ERCP or Percutaneous Transhepatic Cholangiographic (PTC) route. 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
29
Start Date
March 2010
Completion Date
January 13, 2014
Primary Completion Date
January 13, 2014
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michel Kahaleh, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01303159
Organization ID
1107011793
Responsible Party
Principal Investigator
Study Sponsor
Weill Medical College of Cornell University
Collaborators
EMcision Limited
Study Sponsor
Michel Kahaleh, M.D., Principal Investigator, Weill Medical College of Cornell University
Verification Date
April 2017