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NCT02166190 · ClinicalTrials.gov registry record · NA
RFA RCT for Pancreatic or Bile Duct Cancer
A NA study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT02166190 is a NA study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 8 participants.
The verdict
NCT02166190, a NA study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Radiofrequency Ablation using EndoHPB Probe
- PROCEDURE Stenting only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-06 |
| Est. Completion | 2017-05-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02166190
The ClinicalTrials.gov registry entry for NCT02166190 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radiofrequency Ablation using EndoHPB Probe is the first listed.
NCT02166190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02166190 about?
NCT02166190 is a clinical study titled "RFA RCT for Pancreatic or Bile Duct Cancer". 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 ...
What is the current status of trial NCT02166190?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2014-06. Estimated completion is 2017-05-17.
What interventions are being tested in trial NCT02166190?
The interventions under investigation include: Radiofrequency Ablation using EndoHPB Probe (PROCEDURE), Stenting only (PROCEDURE).
Who is sponsoring clinical trial NCT02166190?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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