Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry (RFA-Registry)
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
Bile Duct Cancer
Bile Duct Obstruction
Device: Radio Frequency ablation Probe
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry|
- Change from Baseline in Bile Duct Stricture Diameter. [ Time Frame: 4 years ] [ Designated as safety issue: No ]Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
- Number of Participants with Adverse Events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
- Number of days of survival post intervention [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Documentation of response rates,overall survival duration and overall stent occlusion-free duration.
- Number of overall stent occlusion-free days post intervention [ Time Frame: 4 years ] [ Designated as safety issue: No ]Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: RFA for Pancreatico-biliary disorders
Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.
Device: Radio Frequency ablation Probe
Any probe that can conduct radiofrequency ablation within biliary ducts.
Other Name: ENDOHPB
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:
- 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.
- To assess the immediate and 6 months post procedure adverse event rate in patients.
- To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Michel Kahaleh, MD||Weill Medical College of Cornell University|