Performance of a new preloaded fiducial needle for guided radiation therapy of upper gastrointestinal cancers

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Image guided radiotherapy (IGRT) has recently emerged as a technique for delivering high doses of radiation accurately over a short time span. It has advantages over conventional external beam radiation (EBRT) by minimising radiation exposure to the surrounding tissues and thus potentially reducing toxicities. This has been utilised at a variety of sites, including the pancreas, oesophagus, lung and prostate. Image guidance is best achieved with the implantation of target markers called fiducials or seeds. These are typically composed of gold and there are currently several available on the market. In pancreatic cancer, fiducials are superior to biliary stents in terms of showing tumour position. The technique for implanting fiducials has traditionally been done percutaneously or surgically, but such approach often limited by its invasiveness or the deep location of the cancers such as those from the esophagus or pancreas. Given the ability of EUS to reach these “difficult” organs, the efficacy and safety of EUS guided fiducial insertion for these GI malignancies have been demonstrated recently. The technique of inserting fiducials almost identical to that of FNA/FNB. Compared to percutaneous method, EUS guided fiducial insertion is likely to associated with a reduction in peritoneal seeding risk and obviates the need to traverse other organs. Up to now, 10mm gold Visicoils of various diameter is the fiducial system for EUS insertion. This approach, however, requires individual loading of a single fiducial to the tip of a FNA needle prior to each single deployment, which is tedious and time consuming. More recently, Cook Medical has specifically designed a dedicated 22G EUS guided fiducial needle with 4 x 5mm gold bars preloaded at the tip of the needle. This allows the fiducials to be deployed to target lesions consecutively in a short amount of time, and avoid the need of withdrawing the needle to load the subsequent fiducials. In live porcine model, the use of this needle prototype was associated with safety, high technical success rate and high visibility score on fluoroscopy. Who can participate? Recruitment for this study was done on a retrospective and prospective basis. Data on patients who underwent EUS-guided fiducial placement for SBRT or brachytherapy for GI malignancies were recruited over a 4 year period. Only patients with confirmed malignancy by a cytopathologist and able to give informed consent were included. Aim: The aim of this study is to compare the performance of a new EUS preloaded fiducial needle (Cook Medical) against the conventional coil fiducial (Visicoil) for SBRT and brachytherapy. Hypothesis: It is hypothesized that the new EUS guided preloaded fiducial needle will perform just as well as the conventional coil fiducial, with a 100% technical success rate.

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