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2015-03-06
2019-03-15
2019-03-15
0
NCT02376543
Parkview Health
Parkview Health
INTERVENTIONAL
Comparison Study in Pancreatic Fiducial Placement
Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in Pancreatic Fiducial Placement To Treat Pancreatic Cancer
A prospective multicenter study to compare the cost, time, complications, and migrations rate of two commercially available FDA approved needles; 19 gauge endoscopic ultrasound (EUS) fine needle aspiration (FNA) BNX needles to 22 gauge EUS FNA BNX needles. There will be fiducials placed in the pancreas according to facility policy and procedure. This is a randomized prospective multicenter trial. A minimum of 14 patients and a maximum of 30 patients will be enrolled at up to ten participating sites. Enrollment is projected to be complete within approximately one year. Adult subjects with a diagnosis of pancreatic cancer who will receive SBRT for pancreatic cancer via Cyberknife or Tomotherapy will undergo EUS guided fiducial marker placement. Subjects will be randomized to receive fiducial marker placement with either a 19 gauge EUS, FNA BNX needle or a 22 gauge EUS, FNA BNX needle. For all patients, standard hospital protocol will be followed for EUS procedures and patient care management. The study duration will commence at the time of EUS guided fiducial marker placement and conclude at the time of last SBRT to the pancreas. Cost effectiveness will be evaluated by providing an itemized statement, including anesthesiologist, and endoscopist charges. Time of procedure will be evaluated at time point of first lead needle loaded to time of last marker placed. Time measurement will begin when Endoscopist inserts the echoendoscope into the patient. Thus the patient is under anesthesia, in position, and staff is ready for the case. The time ends once last fiducial marker is placed. Complications will be reported and may include but not limited to pain, bleeding, peritonitis, and pancreatitis. Migration will be reported during the timeframe from simulation to the last day of SBRT. The ability to receive SBRT from this EUS guided fiducial placement will be reported as simply a yes or no. Sites will provide a de-identified itemized statement for EUS guided fiducial placement procedure, prior to any discounted rate, including the endoscopist and anesthesiologist. Follow up evaluations and treatment for pancreatic cancer will be performed in accordance with standard of care procedures and procedures deemed necessary by the attending physician.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-02-20 | N/A | 2020-09-15 |
2015-02-25 | N/A | 2020-09-29 |
2015-03-03 | N/A | 2020-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 19 Gauge EUS FNA BNX Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 19 gauge technique (ARM 1) of EUS guided fiducial marker technique. | DEVICE: 19 Gauge EUS FNA BNX
|
| ACTIVE_COMPARATOR: 22 Gauge EUS FNA BNX Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 22 gauge technique (ARM 2) of EUS guided fiducial marker technique. | DEVICE: 22 Gauge EUS FNA BNX
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Total Cost Comparison | Total cost of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment of pancreatic cancer. | Duration of Fiducial Placement Procedure; approx 30 minutes |
| Total Time Comparison | Time comparison of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment | Duration of fiducial placement procedure; up to 30 minutes |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Migration Comparison | The migration rate of pancreatic fiducials between placement and SBRT treatment | Duration of SBRT treatment; up to 8 weeks. |
| Complication Comparison | Comparison of any fiducial related complications following placement | Duration of SBRT treatment; Up to 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
