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

• Conditions: Bile Duct Obstruction; Bile Duct Cancer; Biliary Stricture; Cholangiocarcinoma; Pancreatic Cancer
• Interventions: Device: Radio Frequency ablation Probe

• Registration Number: NCT01439698
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-20
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RFA for Pancreatico-biliary disorders	Radio Frequency ablation Probe	Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States