RFA-Registry: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01439698

Collaborator

(none)

200

Enrollment

Locations

Duration (Months)

100

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma Pancreatic Cancer Bile Duct Cancer Biliary Stricture Bile Duct Obstruction	Device: Radio Frequency ablation Probe

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:

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: ENDOHPB

Arm

Intervention/Treatment

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 Names:

ENDOHPB

Outcome Measures

Primary Outcome Measures

Change from Baseline in Bile Duct Stricture Diameter. [4 years]
Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
Number of Participants with Adverse Events [4 years]
Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.

Secondary Outcome Measures

Number of days of survival post intervention [4 years]
Documentation of response rates,overall survival duration and overall stent occlusion-free duration.
Number of overall stent occlusion-free days post intervention [4 years]
Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.