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NCT01386931 · ClinicalTrials.gov registry record
On-site Cytopathology EUS-FNA
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 111
- Enrollment target
NCT01386931 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 111 participants.
The verdict
NCT01386931 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 111 participants
- Enrollment target
Study Summary
This study is a multicenter prospective randomized controlled trial. Potential participants in this study include patients referred for Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the patient meets inclusion criteria and signs the informed consent, they will be randomized into one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of fine needle aspiration (FNA) passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, in the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist). The technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized among all endosonographers in order to rule out confounding factors. After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses. Future clinical intervention will be monitored for the purpose of reporting the impact EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients will be followed prospectively for at least one year, and the gold-standard for final diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging follow-up consistent with pancreatic cancer (death or clinical progression). A detailed account of medical equipment used
Interventions
- PROCEDURE EUS-guided FNA performed with on-site Cytopathologist
- PROCEDURE EUS-guided FNA performed without on-site Cytopathologist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-06-16 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386931
The ClinicalTrials.gov registry entry for NCT01386931 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which EUS-guided FNA performed with on-site Cytopathologist is the first listed.
NCT01386931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01386931 about?
NCT01386931 is a clinical study titled "On-site Cytopathology EUS-FNA". This study is a multicenter prospective randomized controlled trial. Potential participants in this study include patients referred for Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the patient meets inclusion crite...
What is the current status of trial NCT01386931?
This trial is currently completed. The enrollment target is 111 participants. The study started on 2011-06. Estimated completion is 2017-06-16.
What interventions are being tested in trial NCT01386931?
The interventions under investigation include: EUS-guided FNA performed with on-site Cytopathologist (PROCEDURE), EUS-guided FNA performed without on-site Cytopathologist (PROCEDURE).
Who is sponsoring clinical trial NCT01386931?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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