Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-03-06
2019-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
19 Gauge EUS FNA BNX
There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 19 gauge needle.
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.
22 Gauge EUS FNA BNX
There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 22 gauge needle.
Interventions
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19 Gauge EUS FNA BNX
There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 19 gauge needle.
22 Gauge EUS FNA BNX
There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 22 gauge needle.
Eligibility Criteria
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Inclusion Criteria
2. Subjects that are deemed physically able to undergo anesthesia (either Monitored Anesthesia Care (MAC) or general anesthesia)
3. Subjects (or the subjects Legally Authorized Representative \[LAR\]) that have agreed to participate in the study and have signed Informed Consent
4. Subjects 18 years of age or older
5. Subject must be able to hold anticoagulants as per institutional standard of care
6. Women of child bearing potential who are not pregnant as proven by a negative pregnancy test
Exclusion Criteria
2. Subjects 17 or under
3. Subjects that refuse treatment for pancreatic cancer d Subjects whose anticoagulants cannot be held
e. Subjects who have distant metastatic disease f. Subjects who cannot or refuse EUS guided procedures. g Subjects who are pregnant
18 Years
ALL
No
Sponsors
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Parkview Health
OTHER
Responsible Party
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Neil Sharma, M.D.
Interventional Gastroenterologist
Principal Investigators
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Neil Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
Parkview Health
Locations
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Parkview Cancer Institute
Fort Wayne, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PRC14-1020 Pancreatic Fiducial
Identifier Type: -
Identifier Source: org_study_id
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