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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Weill Medical College of Cornell University
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: June 11, 2014
Last verified: June 2014
  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: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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.


Estimated 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)
Groups/Cohorts Assigned Interventions
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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Michel Kahaleh, MD 646-962-4000 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MD, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: William R Brugge, MD    617-724-0578    WBRUGGE@PARTNERS.ORG   
Principal Investigator: William R Brugge, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4000    mik9071@med.cornell.edu   
Contact: Monica R Gaidhane, MD, MPH    646 962 4797    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleh, MD         
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: June 11, 2014
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:
Pancreatic Neoplasms
Cholangiocarcinoma
Cholestasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014