Pancreatic Cancer Clinical Trial
— RFA-RegistryOfficial title:
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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
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 |
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