Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.

Pancreatic Cancer Clinical Trial

Official title:

Comparison of Traditional Back-loaded Fiducial Needles With Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement for Image-guided Radiation Therapy in Patients With Pancreatic Cancer: A Multicenter Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332863
• Other study ID #: 14-1711.cc
• Status: Completed
• Phase: N/A
• Start date: August 3, 2016
• Est. completion date: May 1, 2020

Study information

• Verified date: December 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials using fine needle aspiration (FNA) needles. Currently, back-loading the fiducials is the only option for preparing delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with four fiducials has recently been developed, and used in a porcine models with successful results. There are 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.

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.

Description:

Pancreatic cancer is the twelfth most common cancer worldwide. Neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic adenocarcinoma has become standard of care and is associated with higher rates of complete resection ultimately with improvement of overall survival in this patient population. Radiation therapy to a soft tissue organ such as the pancreas can be difficult, as it is not readily visualized radiographically. Image guided radiation therapy (IGRT) is a commonly implemented modality for delivering high doses of radiation directed at cancer tissue, while reducing collateral damage to adjacent healthy tissue. Fiducials, which are inert radiographic markers typically made from gold or carbon, can be placed in and around the tumor to delineate tumor margins to allow for IGRT Endoscopic ultrasound (EUS) has been pivotal in accomplishing IGRT by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials. This has traditionally been accomplished with the use of 19-gauge or 22-gauge fine needle aspiration (FNA) needles. To prepare the needle for fiducial placement, one to two fiducials are manually back-loaded into the tip of the needle after the stylet has been removed. In order to hold the fiducials within the needle, sterile lubrication or bone wax can be applied. Once the pancreatic mass has been targeted, fiducial injection can be accomplished via stylet reinsertion or sterile water injection. Currently, back-loading the fiducials is the only option for preparing delivery of fiducials via the EUS approach. Difficulties associated with fiducial loading and deployment can increase procedure duration due to cumbersome fiducial back-loading, fiducial misplacement & migration, as well as inability to pass the fiducial marker through the needle due to endoscope angulation. Observational studies have sited a technical success rate of 86-100% using 19 and/or 22 gauge needles with average procedure time between 7-12 minutes using the fiducial back-loading technique.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with pathologically confirmed pancreatic cancer referred for image guided radiation therapy (IGRT)

Exclusion Criteria:

• Age <18

• 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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Cook Group Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (18)

Ammar T, Coté 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. — View Citation

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. — View Citation

Dávila 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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Javed S, Bhutani MS. Endoscopic ultrasound-guided radiation therapy in pancreatic cancer. Minerva Gastroenterol Dietol. 2013 Dec;59(4):377-86. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Duration Required for Placing the Fiducial Markers	Duration of procedure for placing fiducial markers including: Fiducial package was opened start time (start stop watch) + Fiducial placement end time (end stop watch) = Placing Fiducial Markers Time	During scheduled procedure (approximately 1 hour)
Secondary	Total Procedure Time	Total procedure time will be recorded during the procedure using a case report form (CRF) for Procedure Time	During scheduled procedure (approximately 1 hour)
Secondary	Number of Participants With Technical Success EUS Needle Visualization	EUS needle visualization during the procedure will be recorded on a CRF for Scale of Technical Success.	During scheduled procedure (approximately 1 hour)
Secondary	Technical Success	Defined as the proper placement of 3 fiducial markers in a pancreatic neoplasm in 2 different planes	During scheduled procedure (approximately 1 hour)
Secondary	Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology	Fiducial location on CT scan will be assessed at patient's radiation oncology appointments for IGRT.	Several hours to 7 days after fiducial marker deployment
Secondary	Number of Participants With Inadvertent Deployment of Fiducials	Whether inadvertent deployment of fiducials occurs will be recorded on a CRF for Data Acquisition	During scheduled procedure (approximately 1 hour)
Secondary	Number of Participants With Ease of Passage of Delivery System	Ease of needle device passage through EUS will be recorded on a CRF form for technical success.	During scheduled procedure (approximately 1 hour)
Secondary	Number of Fiducials Placed	Number of fiducials placed will be recorded during the procedure using a case report form (CRF) for Fiducial Placement Data	During scheduled procedure (about 90 minutes)