Clinical trial · Interventional
Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Back-loaded Needle (Device) | Device | — | UNRESOLVED |
| Preloaded Needle (Device) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Back-loaded needle
- description
- 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.
- interventionNames
- Device: Back-loaded Needle (Device)
- type
- EXPERIMENTAL
- label
- Preloaded Needle
- description
- 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.
- interventionNames
- Device: Preloaded Needle (Device)
Primary outcomes (1)
- measure
- Procedure Duration Required for Placing the Fiducial Markers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (19)
- BACKGROUNDColbert 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. PMID 24390739
- BACKGROUNDFuss 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. PMID 19262697
- BACKGROUNDReese 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. PMID 24635870
- BACKGROUNDJaved S, Bhutani MS. Endoscopic ultrasound-guided radiation therapy in pancreatic cancer. Minerva Gastroenterol Dietol. 2013 Dec;59(4):377-86. PMID 24212355
- BACKGROUNDKooby 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. PMID 23771249
- BACKGROUNDSuzuki 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. PMID 23533319
- BACKGROUNDKhashab 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.