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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01439698
First received: September 20, 2011
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Pancreatic Cancer
Bile Duct Cancer
Biliary Stricture
Bile Duct Obstruction
Device: Radio Frequency ablation Probe
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change from Baseline in Bile Duct Stricture Diameter. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.

  • Number of Participants with Adverse Events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.


Secondary Outcome Measures:
  • Number of days of survival post intervention [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Documentation of response rates,overall survival duration and overall stent occlusion-free duration.

  • Number of overall stent occlusion-free days post intervention [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.


Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 Name: ENDOHPB

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439698

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01439698     History of Changes
Other Study ID Numbers: 1108011875
Study First Received: September 20, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Cholangiocarcinoma
Pancreatic Cancer
Bile Duct Cancer
Biliary Stricture
Bile duct obstruction
ENDOHPB
Radio Frequency Ablation
RFA
ERCP
Endoscopic Retrograde Cholangiopancreatography
Registry
Multicenter

Additional relevant MeSH terms:
Cholestasis
Pancreatic Neoplasms
Cholangiocarcinoma
Bile Duct Neoplasms
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 22, 2014