No registrations found.
ID
Source
Health condition
Patients with (borderline) resectable or locally advanced pancreatic cancer with an indication for radiochemotherapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical 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.
Study objective
EUS-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.
Study design
Follow-up call/visit for complications: 48-72 hours, 7 days and 30 days post-procedure
Intervention
EUS-guided placement of fiducials in a pancreatic tumor
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4252 |
| NTR-old | NTR4490 |
| Other | METC AMC : W14_021 |