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

Image-guided radiochemotherapy in (borderline) resectable and locally advanced pancreatic cancer using fiducials placed under EUS-guidance

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23455

Enrollment

Registered

2014-04-04

Start date

2014-04-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with (borderline) resectable or locally advanced pancreatic cancer with an indication for radiochemotherapy

Interventions

EUS-guided placement of fiducials in a pancreatic tumor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Altered anatomy of the pancreatic region; • Any contraindication for EUS-guided fiducial placement.

Design outcomes

Primary

Measure	Time frame
Clinical success: defined as the ability to use the fiducials in applying image-guided radiotherapy	—

Secondary

Measure	Time frame
• 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.	—

Measure

Time frame

• 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.

—

Contacts

Public ContactS. Lekkerkerker

Dept. of Gastroenterology and Hepatology Academic Medical Center Meibergdreef 9, C2-310

s.j.lekkerkerker@amc.nl+31-205662061

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)