Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
RFA-Registry
1 other identifier
observational
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedFebruary 20, 2017
February 1, 2017
7.3 years
September 20, 2011
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Bile Duct Stricture Diameter.
Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
4 years
Number of Participants with Adverse Events
Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
4 years
Secondary Outcomes (2)
Number of days of survival post intervention
4 years
Number of overall stent occlusion-free days post intervention
4 years
Study Arms (1)
RFA for Pancreatico-biliary disorders
Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.
Interventions
Any probe that can conduct radiofrequency ablation within biliary ducts.
Eligibility Criteria
Subjects over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer
You may qualify if:
- Patients who have undergone RFA for pancreaticobiliary disorders
- Above 18 years of age
You may not qualify if:
- Patients who have not undergone RFA
- Below 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Related 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):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
PMID: 25033929RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Kahaleh, MD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Advanced Endoscopy
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 23, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2018
Study Completion
December 30, 2018
Last Updated
February 20, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
No IPD Sharing