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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: Clinical Trial NA study, sponsored by Weill Medical College of Cornell University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT02166190 stopped before completion
NCT02166190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiofrequency Ablation using EndoHPB Probe is the first listed.
NCT02166190 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02166190's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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