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NCT01514058 · ClinicalTrials.gov registry record · NA
A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction
A NA study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01514058 is a NA study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 8 participants.
The verdict
NCT01514058, a NA study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
Patients who present with obstructive jaundice due to a malignant stricture often undergo a battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom relief as well as brushings for cytology. An endoscopic ultrasound is performed as well for fine needle aspiration (FNA) of the pancreas to aid in diagnosis. However, since EUS is not available at many centers, patients often undergo an initial ERCP procedure with stent placement (which is more widely available) prior to referral for EUS. It has been reported that biliary stents can disturb EUS visualization due to inflammation, acoustic shadowing, and pneumobilia which may lessen the accuracy of diagnosis.1 The cytological yield from the EUS with FNA procedure may also be compromised in patients with biliary stents. As such, diagnosis and treatment options may be delayed. One retrospective study of 65 subjects showed a significant difference in the number of correctly staged pancreatic head cancers (mainly T stage) in patients without stents versus those with biliary stents (85% vs 47%).2 A second retrospective study concluded that tissue diagnosis is not influenced in patients with stents placed greater than 24 hours before the EUS; however, patients with stents placed just prior to the EUS (less than 24 hours) were more likely to have indeterminate results.1 Although the findings are suggestive, the studies are limited by their retrospective design and these questions have not yet been addressed in a prospective study. Both procedures require anesthesia, and when performed sequentially in the same setting, the duration of anesthesia is prolonged. This is concerning for the patient since complications may theoretically increase with prolonged anesthesia. However, a retrospective review at a tertiary referral center showed that combined EUS and ERCP yielded a complication rate no higher than th
Interventions
- PROCEDURE EUS-FNA first, followed by CRCP with bilinary stenting
- PROCEDURE ERCP with stent placement, followed by EUS-FNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01514058
The ClinicalTrials.gov registry entry for NCT01514058 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 Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EUS-FNA first, followed by CRCP with bilinary stenting is the first listed.
NCT01514058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01514058 about?
NCT01514058 is a clinical study titled "A Prospective, Randomized Study Evaluating the Effect of Biliary Stenting on EAU-FNA in Patients With Suspected Malignant Biliary Obstruction". Patients who present with obstructive jaundice due to a malignant stricture often undergo a battery of tests for diagnosis, treatment options, and prognosis. An endoscopic retrograde cholangiopancreatography (ERCP) is often performed with biliary stent placement for symptom relief as well as brushin...
What is the current status of trial NCT01514058?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01514058?
The interventions under investigation include: EUS-FNA first, followed by CRCP with bilinary stenting (PROCEDURE), ERCP with stent placement, followed by EUS-FNA (PROCEDURE).
Who is sponsoring clinical trial NCT01514058?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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