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

Pancreatic Cancer Clinical Trial

— RFA-Registry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01439698
• Other study ID #: 1108011875
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2011
• Last updated: February 16, 2017
• Start date: September 2011
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, MD
• Phone: 646-962-4000
• Email: mik9071[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Bile Duct Obstruction
• Biliary Stricture
• Cholangiocarcinoma
• Cholestasis
• Constriction, Pathologic
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Radio Frequency ablation Probe
Any probe that can conduct radiofrequency ablation within biliary ducts.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Bile Duct Stricture Diameter.	Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.	4 years
Primary	Number of Participants with Adverse Events	Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.	4 years
Secondary	Number of days of survival post intervention	Documentation of response rates,overall survival duration and overall stent occlusion-free duration.	4 years
Secondary	Number of overall stent occlusion-free days post intervention	Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.	4 years