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

February 16, 2017 updated by: Michel Kahaleh, Weill Medical College of Cornell University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • William R Brugge, MD
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RFA for Pancreatico-biliary disorders
Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies.
Device: Radio Frequency ablation Probe
Any probe that can conduct radiofrequency ablation within biliary ducts.
Other Names:
  • ENDOHPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Bile Duct Stricture Diameter.
Time Frame: 4 years
Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
4 years
Number of Participants with Adverse Events
Time Frame: 4 years
Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days of survival post intervention
Time Frame: 4 years
Documentation of response rates,overall survival duration and overall stent occlusion-free duration.
4 years
Number of overall stent occlusion-free days post intervention
Time Frame: 4 years
Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1108011875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD Sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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