Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
NCT ID: NCT02332863
Last Updated: 2020-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2016-08-03
2020-05-01
Brief Summary
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Hypotheses
Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with pancreatic cancer will:
1. Be delivered in at least require 60% less of the procedure time that it takes for traditional back-loaded 22G needles
2. Improve overall procedure efficiency
3. Maintain comparable technical success and adverse event rates.
Primary Aims
1\) To compare the procedure time of 22G needle placement of three Visicoil (brand of flexible linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded fiducial markers.
Secondary Aims
1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers
2. To compare endpoints of technical success defined as proper placement of two to three fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers.
Detailed Description
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A new mode of fiducial delivery has recently been developed that hopes to circumvent some of the technical issues inherent to traditional fiducial marker loading and deployment. A prototype 22-Gauge EUS needle preloaded with four fiducials has been used in a porcine models with successful deployment 95.6% of the time all accurate on predetermined targets. They were deemed easy to pass, relatively easy to deploy, and easily visualized on EUS, with excellent fluoroscopic and CT visualization. In addition, time for deployment was on average less than 60 seconds.
To date, there is no randomized controlled trials comparing total duration of time needed for placement of fiducials using technical success of the traditional back- loading technique of fiducial markers to the new preloaded needles in regards to EUS based fiducial marker placement for IGRT in pancreatic cancer.
This will be a multicenter randomized controlled trial. Randomization be performed and patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle (Visicoil) or the new 22G preloaded needle (PreLoad4). Multiple endpoints will be recorded, including total length of procedure, how many markers are successfully deployed, and technical success (Ease of passage of delivery system, ease of deployment of fiducials, EUS visualization of delivery system needle, EUS visual appearance of fiducials, and time for fiducial placement defined as starting at time of removing the needle from its packaging and ending time as removal of needle after final marker deployment). Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation. Patients will be discharged home after post procedure recovery. Patients will be contacted at home by a research coordinator or endoscopy staff 24-48 hours and 7-10 days after the procedure to document any immediate and delayed complications. Patients will return for their IGRT visit, and any evidence of fiducial marker migration will be recorded by the radiation oncologist.
Hypotheses
Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with pancreatic cancer will:
1. Be delivered in at least require 60% less of the procedure time that it takes for traditional back-loaded 22G needles
2. Improve overall procedure efficiency
3. Maintain comparable technical success and adverse event rates.
Primary Aims
1\) To compare the procedure time of 22G needle placement of three Visicoil fiducial markers and 22G needle preloaded fiducial markers.
Secondary Aims
1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers
2. To compare endpoints of technical success defined as proper placement of two to three fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Back-loaded needle
The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.
Back-loaded Needle (Device)
Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:
* total length of procedure
* how many markers are successfully deployed
* technical success
Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.
Preloaded Needle
The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.
Preloaded Needle (Device)
Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:
* total length of procedure
* how many markers are successfully deployed
* technical success
Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.
Interventions
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Back-loaded Needle (Device)
Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:
* total length of procedure
* how many markers are successfully deployed
* technical success
Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.
Preloaded Needle (Device)
Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:
* total length of procedure
* how many markers are successfully deployed
* technical success
Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to consent
* Known coagulopathy/thrombocytopenia (INR \>1.5, platelets \<75)
* Patients on antiplatelet/anticoagulant medication that cannot safely be discontinued 5-7 days prior to the procedure
* Gold allergy
* Current infection
* EUS evidence of vessel interfering with path of fiducial marker
* Pregnancy
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sachin Wani, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Countries
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References
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Colbert LE, Hall WA, Nickleach D, Switchenko J, Kooby DA, Liu Y, Gillespie T, Lipscomb J, Kauh J, Landry JC. Chemoradiation therapy sequencing for resected pancreatic adenocarcinoma in the National Cancer Data Base. Cancer. 2014 Feb 15;120(4):499-506. doi: 10.1002/cncr.28530. Epub 2014 Jan 3.
Fuss M, Wong A, Fuller CD, Salter BJ, Fuss C, Thomas CR. Image-guided intensity-modulated radiotherapy for pancreatic carcinoma. Gastrointest Cancer Res. 2007 Jan;1(1):2-11.
Reese AS, Lu W, Regine WF. Utilization of intensity-modulated radiation therapy and image-guided radiation therapy in pancreatic cancer: is it beneficial? Semin Radiat Oncol. 2014 Apr;24(2):132-9. doi: 10.1016/j.semradonc.2013.11.003.
Javed S, Bhutani MS. Endoscopic ultrasound-guided radiation therapy in pancreatic cancer. Minerva Gastroenterol Dietol. 2013 Dec;59(4):377-86.
Kooby DA, Gillespie TW, Liu Y, Byrd-Sellers J, Landry J, Bian J, Lipscomb J. Impact of adjuvant radiotherapy on survival after pancreatic cancer resection: an appraisal of data from the national cancer data base. Ann Surg Oncol. 2013 Oct;20(11):3634-42. doi: 10.1245/s10434-013-3047-x. Epub 2013 Jun 15.
Suzuki R, Irisawa A, Bhutani MS. Endoscopic ultrasound-guided oncologic therapy for pancreatic cancer. Diagn Ther Endosc. 2013;2013:157581. doi: 10.1155/2013/157581. Epub 2013 Feb 24.
Khashab MA, Kim KJ, Tryggestad EJ, Wild AT, Roland T, Singh VK, Lennon AM, Shin EJ, Ziegler MA, Sharaiha RZ, Canto MI, Herman JM. Comparative analysis of traditional and coiled fiducials implanted during EUS for pancreatic cancer patients receiving stereotactic body radiation therapy. Gastrointest Endosc. 2012 Nov;76(5):962-71. doi: 10.1016/j.gie.2012.07.006.
Ammar T, Cote GA, Creach KM, Kohlmeier C, Parikh PJ, Azar RR. Fiducial placement for stereotactic radiation by using EUS: feasibility when using a marker compatible with a standard 22-gauge needle. Gastrointest Endosc. 2010 Mar;71(3):630-3. doi: 10.1016/j.gie.2009.11.023.
Park WG, Yan BM, Schellenberg D, Kim J, Chang DT, Koong A, Patalano C, Van Dam J. EUS-guided gold fiducial insertion for image-guided radiation therapy of pancreatic cancer: 50 successful cases without fluoroscopy. Gastrointest Endosc. 2010 Mar;71(3):513-8. doi: 10.1016/j.gie.2009.10.030.
Davila Fajardo R, Lekkerkerker SJ, van der Horst A, Lens E, Bergman JJ, Fockens P, Bel A, van Hooft JE. EUS-guided fiducial markers placement with a 22-gauge needle for image-guided radiation therapy in pancreatic cancer. Gastrointest Endosc. 2014 May;79(5):851-5. doi: 10.1016/j.gie.2013.12.027. Epub 2014 Feb 8. No abstract available.
DiMaio CJ, Nagula S, Goodman KA, Ho AY, Markowitz AJ, Schattner MA, Gerdes H. EUS-guided fiducial placement for image-guided radiation therapy in GI malignancies by using a 22-gauge needle (with videos). Gastrointest Endosc. 2010 Jun;71(7):1204-10. doi: 10.1016/j.gie.2010.01.003.
Owens DJ, Savides TJ. EUS placement of metal fiducials by using a backloaded technique with bone wax seal. Gastrointest Endosc. 2009 Apr;69(4):972-3. doi: 10.1016/j.gie.2008.05.052. Epub 2009 Jan 18. No abstract available.
Khara HS, Pineda-Bonilla JJ, Chaput KJ, Johal AS. Endoscopic ultrasound-guided placement of fiducial markers using a novel "wet-fill technique" without a bone wax seal. Endoscopy. 2013;45 Suppl 2 UCTN:E426-7. doi: 10.1055/s-0033-1358809. Epub 2013 Dec 13. No abstract available.
Pishvaian AC, Collins B, Gagnon G, Ahlawat S, Haddad NG. EUS-guided fiducial placement for CyberKnife radiotherapy of mediastinal and abdominal malignancies. Gastrointest Endosc. 2006 Sep;64(3):412-7. doi: 10.1016/j.gie.2006.01.048.
Varadarajulu S, Trevino JM, Shen S, Jacob R. The use of endoscopic ultrasound-guided gold markers in image-guided radiation therapy of pancreatic cancers: a case series. Endoscopy. 2010 May;42(5):423-5. doi: 10.1055/s-0029-1243989. Epub 2010 Mar 15.
Sanders MK, Moser AJ, Khalid A, Fasanella KE, Zeh HJ, Burton S, McGrath K. EUS-guided fiducial placement for stereotactic body radiotherapy in locally advanced and recurrent pancreatic cancer. Gastrointest Endosc. 2010 Jun;71(7):1178-84. doi: 10.1016/j.gie.2009.12.020. Epub 2010 Apr 1.
Draganov PV, Chavalitdhamrong D, Wagh MS. Evaluation of a new endoscopic ultrasound-guided multi-fiducial delivery system: a prospective non-survival study in a live porcine model. Dig Endosc. 2013 Nov;25(6):615-21. doi: 10.1111/den.12046. Epub 2013 Mar 12.
Fuccio L, Guido A, Larghi A, Antonini F, Lami G, Fabbri C. The role of endoscopic ultrasound in the radiation treatment of pancreatic tumor. Expert Rev Gastroenterol Hepatol. 2014 Sep;8(7):793-802. doi: 10.1586/17474124.2014.913479. Epub 2014 Apr 28.
Machicado JD, Obuch JC, Goodman KA, Schefter TE, Frakes J, Hoffe S, Latifi K, Simon VC, Santangelo T, Ezekwe E, Edmundowicz SA, Brauer BC, Shah RJ, Hammad HT, Wagh MS, Attwell A, Han S, Klapman J, Wani S. Endoscopic Ultrasound Placement of Preloaded Fiducial Markers Shortens Procedure Time Compared to Back-Loaded Markers. Clin Gastroenterol Hepatol. 2019 Dec;17(13):2749-2758.e2. doi: 10.1016/j.cgh.2019.04.046. Epub 2019 Apr 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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14-1711.cc
Identifier Type: -
Identifier Source: org_study_id