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RFA RCT for Pancreatic or Bile Duct Cancer (RFARCT)

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ClinicalTrials.gov Identifier: NCT02166190
Recruitment Status : Recruiting
First Posted : June 18, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

Malignant obstructive jaundice is a common complication of advanced stage pancreatic adenocarcinoma and cholangiocarcinoma. Over 50% of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of self-expanding metal stents (SEMSs) for palliation is the therapy of choice in this set of patients. Conventional stent placement provides palliation for a limited duration only and these subjects come back with obstructive jaundice. Due to age, comorbidities, malignant disease status, it is better to conduct reduced number of therapeutic endoscopies to reduce the number of complications. Additionally, only biliary stenting itself may provide only palliation, and not increase the duration of survival.

Currently, there are only two therapies. Recently, photodynamic therapy (PDT) has been evaluated as a palliative and potential neoadjuvant modality. Therefore if RFA confers similar benefits, then it may potentially be used as an alternative to PDT, given the lower adverse event profile. More recently, RFA has been recognized for its potential in palliative treatment of malignant biliary strictures. Based on the published data, RFA provides palliation and seems to increase survival duration in pancreatic cancer. Our own limited experience shows the same. The goal of this randomized controlled trial is to definitely confirm the benefit of Radiofrequency ablation (RFA) in providing increased survival time and quality of life in patients with non-resectable cholangiocarcinoma and pancreatic cancer. These benefits will improve clinical practice by making RFA the new standard of care for unresectable cholangiocarcinoma (CCA) and pancreatic cancer (PC). It will also enhance scientific knowledge by opening the door for new opportunities, e.g. RFA as a potential use for neoadjuvant therapy or as a downstaging agent for surgically resectable patients.


Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Cholangiocarcinoma Non-resectable Procedure: Radiofrequency Ablation using EndoHPB Probe Procedure: Stenting only Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Radiofrequency Ablation and Stenting vs. Stenting Alone for Biliary Obstruction Due to Unresectable Cholangiocarcinoma and Pancreatic Cancer
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiofrequency Ablation (EndoHbp probe)
Radiofrequency Ablation using EndoHPB Probe
Procedure: Radiofrequency Ablation using EndoHPB Probe
Radiofrequency Ablation using EndoHPB Probe

Active Comparator: Stenting only
Stenting only
Procedure: Stenting only
Stenting only




Primary Outcome Measures :
  1. Clinical Success- composite [ Time Frame: 1 year ]
    Clinical Success Composite of Stent patency, serum bilirubin and general quality of life measured at 3 months, 6 months, 9 months and 12 months as well as survival duration.


Secondary Outcome Measures :
  1. Mutational Profile of DNA post interventional procedure [ Time Frame: 1 year ]
    Mutational profile of DNA using FISH (Fluorescence in situ hybridization) analysis on brushings of bile duct after RFA procedure to further understand the implications at the cellular and genetic level at 1 month, 3 months, 6 months, and 9 months


Other Outcome Measures:
  1. Safety Profile and Quality of Life [ Time Frame: 1 year ]
    Number of adverse events, severity and frequency of adverse events and relatedness to procedure within 30 days of the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Either gender greater than or equal to 18 years of age.

  • Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced. Subjects that are deemed to be unresectable will be determined by a surgeon or treating oncologist.
  • Biliary obstruction
  • Subjects capable of giving informed consent
  • Life expectancy of at least 6 months

Exclusion Criteria:

- Exclusion Criteria

  • Cardiac Pacemaker
  • Patient unstable for ERCP or has failed ERCP (endoscopic retrograde cholangiopancreatography )
  • Inability to give informed consent
  • Uncorrected coagulopathy
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166190


Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Reem Z Sharaiha, MD    646-962-4000    rzs9001@med.cornell.edu   
Principal Investigator: Reem Z Sharaiha, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Reem Z Sharaiha, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02166190     History of Changes
Other Study ID Numbers: 1403014843
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
Pancreatic cancer
cholangiocarcinoma
radiofrequency ablation

Additional relevant MeSH terms:
Cholangiocarcinoma
Pancreatic Neoplasms
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