Study Stopped
Enrollment was feasibly not going to be reached.
RFA RCT for Pancreatic or Bile Duct Cancer
RFARCT
Randomized Controlled Trial Comparing Radiofrequency Ablation and Stenting vs. Stenting Alone for Biliary Obstruction Due to Unresectable Cholangiocarcinoma and Pancreatic Cancer
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedSeptember 30, 2019
September 1, 2019
3 years
June 11, 2014
September 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Success- composite
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.
1 year
Secondary Outcomes (1)
Mutational Profile of DNA post interventional procedure
1 year
Other Outcomes (1)
Safety Profile and Quality of Life
1 year
Study Arms (2)
Radiofrequency Ablation (EndoHbp probe)
EXPERIMENTALRadiofrequency Ablation using EndoHPB Probe
Stenting only
ACTIVE COMPARATORStenting only
Interventions
Radiofrequency Ablation using EndoHPB Probe
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- Cardiac Pacemaker
- Patient unstable for ERCP or has failed ERCP (endoscopic retrograde cholangiopancreatography )
- Inability to give informed consent
- Uncorrected coagulopathy
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reem Z Sharaiha, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 18, 2014
Study Start
June 1, 2014
Primary Completion
May 17, 2017
Study Completion
May 17, 2017
Last Updated
September 30, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share
No IPD sharing