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

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Brief Title

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

Official Title

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

Brief Summary

      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
      gallbladder 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 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
    

Detailed Description

      Background

      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
      gallbladder 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 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

      Objectives:

      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 since June 2011 and is
      ongoing until June 2017:

        -  To document the immediate and post procedure clinical performance of radio frequency
           ablation in a "real world" patient population requiring stent implantation for
           pancreatico-biliary 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
           pancreatico-biliary malignancies.

      Study Design at Coordinating Center - Weill Cornell Medical College Primary site (WCMC):

      This study entails review of data from a database protocol [IRB # 1104011642 : collected for
      non-research related purposes]. The purpose of this protocol is to establish a database that
      captures all Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and
      Interventional endoscopy cases. Its objective is to assess prospectively the efficacy and
      safety of these routine procedures to permit identification of technical details about the
      procedures or other factors, which might be associated with outcome or results. Assessment of
      these details would help us with problem identification and recommendations to improve health
      outcomes and quality of life in these patients

      The registry will review and document:

        -  All patients who have had Interventional Endoscopy procedures done which involved radio
           frequency ablations for pancreatico-biliary disorders since June 2011 and extending
           forward through June 2017.

        -  Data will be reviewed and collected from database protocol IRB # 1104011642.

        -  No subject intervention is involved in this study. Subject contact is not needed for
           database review.

      Study Design at Secondary sites:

      The registry will review and document:

        -  All patients who have had Interventional Endoscopy procedures done which involved radio
           frequency ablations for pancreatico-biliary disorders.

        -  No subject intervention is involved in this study. Subject contact is not needed for
           retrospective review.

        -  These sites would have IRB approved protocols to collect and send radio frequency
           ablation procedure data to the primary site (WCMC). Additionally, the secondary study
           sites would mention WCMC as an entity that could receive PHI in their prospective
           protocols and consent/HIPAA forms.

        -  All secondary study sites' IRB approvals will be sent to the primary/coordinating study
           center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as
           soon as they are received from the secondary study sites.

        -  Relevant IRB documentation will be maintained at both primary and secondary sites.

      Registry Hosting:

      The coordinating center and primary site (WCMC) will host the registry on the local servers.

      A secure Data management or Electronic Data Capture (EDC) system will be used for data entry,
      compilation and querying.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Measurement of Bile Duct Stricture Diameter

Secondary Outcome

 survival duration

Condition

Bile Duct Cancer

Intervention

Interventional Endoscopy procedures

Study Arms / Comparison Groups

 Interventional Endoscopy procedures
Description:  All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2023.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

8

Start Date

January 25, 2016

Completion Date

March 30, 2021

Primary Completion Date

March 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  All patients who have had Interventional Endoscopy procedures done which involved
             radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.

          -  Above 18 years of age.

        Exclusion Criteria:

          -  Any patient who has not undergone interventional endoscopy with RFA and stent
             insertion(s).

          -  Below 18 years of age
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Prashant Kedia, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04937322

Organization ID

003.GID.2016.D


Responsible Party

Sponsor

Study Sponsor

Methodist Health System

Collaborators

 Weill Medical College of Cornell University

Study Sponsor

Prashant Kedia, MD, Principal Investigator, Methodist Dallas Medical Center


Verification Date

November 2021