Clinical trial NCT01439698: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
Official title: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Pancreatic Cancer
Bile Duct Cancer
Biliary Stricture
Bile Duct Obstruction
Keywords: Cholangiocarcinoma
Pancreatic Cancer
Bile Duct Cancer
Biliary Stricture
Bile duct obstruction
ENDOHPB
Radio Frequency Ablation
RFA
ERCP
Endoscopic Retrograde Cholangiopancreatography
Registry
Multicenter
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer

Brief summary: 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.

Detailed description: 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:

1. 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.
2. To assess the immediate and 6 months post procedure adverse event rate in patients.
3. To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone RFA for pancreaticobiliary disorders
* Above 18 years of age

Exclusion Criteria:

* Patients who have not undergone RFA
* Below 18 years of age

Primary outcomes:
measure: Change from Baseline in Bile Duct Stricture Diameter.
timeFrame: 4 years
measure: Number of Participants with Adverse Events
timeFrame: 4 years
Secondary outcomes:
measure: Number of days of survival post intervention
timeFrame: 4 years
measure: Number of overall stent occlusion-free days post intervention
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.