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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Procedure: Stenting only
- 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.
- 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
- 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.
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
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Reem Z Sharaiha, MD 646-962-4000 firstname.lastname@example.org|
|Principal Investigator: Reem Z Sharaiha, MD|
|Principal Investigator:||Reem Z Sharaiha, MD||Weill Medical College of Cornell University|