RFA RCT for Pancreatic or Bile Duct Cancer

Stopped early · Not applicable

Conditions studied: Unresectable Pancreatic Cancer, Cholangiocarcinoma Non-resectable

In brief

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.

Key facts

Study ID

NCT02166190

Run by

Weill Medical College of Cornell University

People needed

8

Starts

2014-06-01

Expected to finish

2017-05-17

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

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

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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