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Image-guided radiochemotherapy in patients with pancreatic cancer using gold markers placed during endoscopic ultrasound.


- candidate number17156
- NTR NumberNTR4490
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2014
- Secondary IDsW14_021 METC AMC
- Public TitleImage-guided radiochemotherapy in patients with pancreatic cancer using gold markers placed during endoscopic ultrasound.
- Scientific TitleImage-guided radiochemotherapy in (borderline) resectable and locally advanced pancreatic cancer using fiducials placed under EUS-guidance
- ACRONYM
- hypothesisEUS-guided fiducial placement in pancreatic tumors is a technically successfull and safe procedure. After placement fiducials can be successfully used for highly-accurate delivery of image-guided radiotherapy.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, Ultrasound, Chemoradiotherapy
- Inclusion criteria Patient over 17 years old; Indication for radio(chemo)therapy for pancreatic carcinoma; WHO performance status of 0-2; Verbal informed consent.
- Exclusion criteria Altered anatomy of the pancreatic region; Any contraindication for EUS-guided fiducial placement.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-apr-2014
- planned closingdate
- Target number of participants50
- InterventionsEUS-guided placement of fiducials in a pancreatic tumor
- Primary outcomeClinical success: defined as the ability to use the fiducials in applying image-guided radiotherapy
- Secondary outcome Technical success: defined as the ability to implant at least three fiducials in the tumour area; Technical difficulty: cumbersome loading or unloading of a fiducial. After the procedure the endosonographers will value the ease of placement by filling out a scale of 1-5, to evaluate the ease of placement of the fiducials. A value of ≥ 4 is considered difficult; Safety: the procedure is considered safe if the maximum rate of SAEs related to the EUS-guided fiducial placement does not exceed 5%, based on the number of major complications following EUS-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses (2.5% (95% CI 0.7-6.3%);20,21 Migration: change in interfiducial distance. The coordinates of the fiducials are determined by manually selecting the centre of each fiducial on the reference scan. From these 3D coordinates, the interfiducial distances are calculated; Complete migration: non-visualization of a fiducial on the reference scan, or the disappearance of a previously visualized fiducial on any of the following CBCT scans.
- TimepointsFollow-up call/visit for complications: 48-72 hours, 7 days and 30 days post-procedure
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Lekkerkerker
- CONTACT for SCIENTIFIC QUERIES S. Lekkerkerker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-apr-2014 - 27-apr-2014


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