Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry (RFA-Registry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01439698|
Recruitment Status : Recruiting
First Posted : September 23, 2011
Last Update Posted : February 20, 2017
|Condition or disease||Intervention/treatment|
|Cholangiocarcinoma Pancreatic Cancer Bile Duct Cancer Biliary Stricture Bile Duct Obstruction||Device: Radio Frequency ablation Probe|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 30, 2018|
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
- Change from Baseline in Bile Duct Stricture Diameter. [ Time Frame: 4 years ]Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
- Number of Participants with Adverse Events [ Time Frame: 4 years ]Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
- Number of days of survival post intervention [ Time Frame: 4 years ]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 ]Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439698
|Contact: Michel Kahaleh, MDemail@example.com|
|Contact: Monica R Gaidhane, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: William R Brugge, MD 617-724-0578 WBRUGGE@PARTNERS.ORG|
|Principal Investigator: William R Brugge, MD|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Michel Kahaleh, MD 646-962-4000 email@example.com|
|Contact: Monica R Gaidhane, MD, MPH 646 962 4797 firstname.lastname@example.org|
|Principal Investigator: Michel Kahaleh, MD|
|Principal Investigator:||Michel Kahaleh, MD||Weill Medical College of Cornell University|