Gold Anchor enables safe reach to inner organs

Transcription

1 Gold Anchor enables safe reach to inner organs Fine needles for cytology have been used >50 years in all parts of the human body with no to very little harm Gold Anchor comes pre-loaded in needles of the same size Advantages: Reduced risk of pneumothorax Reduced patient discomfort - Less need for anesthesia Less risk of infection and bleeding Less risk of seeding of cancer cells Picture from

2 Reduced risk of pneumothorax Incidence of pneumothorax during percutaneous transthoracic needle aspiration biopsy of the lung Needle size used with traditional markers N/A 8.. Needle size used with Gold Anchor 16.1% 8. 17G 18G 19G G 4/5G (n=4) (n=5) (n=440) Needle gauge (sample size) (n=50) Possibly higher risk for cancer patients In our experience, ~5 of these patients developed pneumothorax, as might be expected in patients with severe lung disease. This is similar to the rate typically described for transcutaneous needle biopsies of lung lesions Pneumothorax developing after transcutaneous placement of fiducial markers frequently necessitated hospitalization with chest tube placement. This may be explained by the rapid progression to tension pneumothorax or an increased likelihood of symptomatic stable pneumothorax in a population with poor pulmonary reserve. Source: Kupelian PA, Forbes A,Willoughby TR, et al. Implantation and stability of metallic fiducials within pulmonary lesions. Int J Radiat Oncol Biol Phys 007;69: Source (18G and 19G): Geraghty, PR, Kee, ST, McFarlane, G, et al. CT-guided transthoracic needle aspiration biopsy of pulmonary nodules: needle size and pneumothorax rate. Radiology 00;9, Source (G): W S Chin, I Sng. The Chiba needle for percutaneous lung biopsy. Sing Med J. 1988; 9: 71-7 Source (4/5G): Zavala DC, Schoell JE. Ultrathin needle aspiration of the lung in infectious and malignant disease. Am Rev Respir Dis. 1981;1(1):15-1

3 Reduced risk of pneumothorax Incidence of pneumothoraces needing treatment after percutaneous transthoracic needle aspiration biopsy of the lung 6 5 Needle size used with traditional markers Needle size used with Gold Anchor Treatment = Aspiration 4 = Chest tube 1 4.7% 1.1% N/A..% 17G 18G 19G G 5G (n=4) (n=5) (n=440) (n=95) Needle gauge (sample size) Nominal outer diameter Gauge mm inches 17G G G G G Source (18G and 19G): Geraghty, PR, Kee, ST, McFarlane, G, et al. CT-guided transthoracic needle aspiration biopsy of pulmonary nodules: needle size and pneumothorax rate. Radiology 00;9, Source (G): W S Chin, I Sng. The Chiba needle for percutaneous lung biopsy. Sing Med J. 1988; 9: 71-7 Source (5G): I. Naslund, P. Wersall, E. Castellanos, et al. Gold Anchor marker for IGRT, a new fiducial for high-precision radiotherapy Int J Radiat Oncol Biol Phys 009;75:S608-S609

4 Reduced patient discomfort Intensity of pain during transrectal implantation in prostate without local anaesthesia 17G; 1.x mm markers 18G; 1x7 mm markers 18G; 1x5 mm markers with local anaesthesia G; Gold Anchor (0=no pain; 5=worst possible) (0=no pain; 10=the worst pain imaginable) (0=no pain; 5=severe pain) (0=no pain; 10=the worst pain imaginable) % 6% 1 15% 6% Mean pain score: 1.7 out of 5 = ~.4 out of : 15% -5: 7% 0-: 48% Mean pain score:. out of % 8% 4% 1 6% 9% Mean pain score: 1.1 out of 5 = ~. out of 10 With local anaesthesia % 0.% 1.7% 1.4% 4.4% 8.% 7.5% Mean pain score: 0.6 out of 10 76% Share of patients (n=15) Share of patients (n=09) Share of patients (n=9) Share of patients (n=6) Source (G): Wioletta Mista, Leszek Miszczyk. An evaluation of side effects after gold markers (Gold Anchor ) implantation to prostate gland in patients with prostate cancer. Onkologia Info 011;8;: Source (18G; 1x5 mm): S Gill, J Li, J Thomas, et al. Patient-reported complications from fiducial marker implantation for prostate image-guided radiotherapy. Br J Radiol. 01 Jul;85(1015): Source (18G; 1x7 mm): Langenhuijsen JF, van Lin EN, Kiemeney LA, et al. Ultrasound-guided transrectal implantation of gold markers for prostate localization during external beam radiotherapy: complication rate and risk factors. Int J Radiat Oncol Biol Phys 007;69: Source (17G): Igdem S, Akpinar H, Alço G, et al. Implantation of fiducial markers for image guidance in prostate radiotherapy: patient-reported toxicity. Br J Radiol 009;8:

5 Less risk of infection and bleeding Some* complications after transrectal implantation in prostate 17G; 1.x mm 18G; 1x7 mm 18G; 1x5 mm G; Gold Anchor Rectal bleeding.7% 9.1% 11%.8% Hematuria total > days 14.8%? 1.5% 8.1%..8%.%? Fever.% 1.9% % 1.1% Some comments on preparations: Antibiotics ( days) Enema used Anticoagulation/ antiplatelet medication stopped 7 days before implantation Antibiotics ( days) No laxatives/enema Anticoagulation medication stopped 7 days before implantation Antibiotics (4 days) Two microlax enemas Anticoagulation medication stopped 7-10 days before implantation Antibiotics Laxatives Note: *All complications are not shown. The complications above are those that were mentioned in all four articles. Source: See previous page.

6 Less risk of seeding of cancer cells Example of implantation metastasis (in lung) What is tumor seeding? Targeting lesions using a percutaneous approach requires the needle to be introduced across a number of tissue planes; initially through skin, and thereafter through intervening tissues, which often include subcutaneous fat, fascial layers, pleura, and muscle, depending on anatomical location Tumor seeding occurs when malignant cells are deposited along the needle tract during the biopsy procedure. This can occur within the organ harbouring the abnormality or within overlying tissues Source (text): Robertson EG, Baxter G. Tumour seeding following percutaneous needle biopsy: The real story! Clin Radiol. 011 Nov;66(11): Source (pictures): Ibukuro K, Tanaka R, Takeguchi T, et al. Air Embolism and Needle Track Implantation Complicating CT-Guided Percutaneous Thoracic Biopsy: Single-Institution Experience. Am. J. Roentgenol. 009;19:W40-W46 6

7 Less risk of seeding of cancer cells Risk of seeding varies with organ......and with type of tumor (liver example) Low risk in general Needle tract seeding is a potential risk [of percutaneous needle biopsy], yet has been demonstrated to be an extremely unlikely outcome of these procedures. Low risk in lung and kidney Needle tract seeding following biopsy of intra-pulmonary lesions and renal lesions is extremely rare... Share of patients with implantation metastases after fine-needle aspiration cytology (FNAC) of liver tumors 1% 1 8% 9.8% Somewhat higher risk in primary liver tumors The likelihood of needle tract seeding following biopsy of HCC [hepatocellular carcinoma] may previously have been exaggerated; in most circumstances, the benefit of accurate diagnosis will outweigh the perceived risks of biopsy... 6% 4% %.% 0.9% Higher risk in certain cases Percutaneous needle biopsy of primary malignant pleural disease and of colorectal liver metastasis confers similar tumour seeding risk; the decision to perform biopsies should be considered on a case by case basis but biopsy is likely to be contraindicated in candidates for hepatic metastasectomy. Colorectal CM Non-colorectal N-C M Primary HCCtumor metastasis metastasis (HCC) (n=51) (n=46) (n=106) n = number of patients with malignant diagnosis FNAC was carried out with 0- or -G needles Source (quotes above): Robertson EG, Baxter G. Tumour seeding following percutaneous needle biopsy: The real story! Clin Radiol. 011 Nov;66(11): Source (liver example): Ohlsson B, Nilsson J, Stenram U, et al. Percutaneous fine-needle aspiration cytology in the diagnosis and management of liver tumours. Br J Surg. 00 Jun;89(6):757-6

8 Less risk of seeding of cancer cells Risk seems to vary with needle type......and with needle size Share of needle passes resulting in implantation metastases after biopsy of liver tumors % Share of invasive procedures resulting in implantation metastases after biopsy and PEI of liver tumors % 1% 1% 0.45% > <0.11% 19.5 end-cutting _ 18G tru-cut _ 18G tru-cut _ G aspiration _ (n=1785) (n=17) (n>1) (n<1175) n = number of needle passes in patients with hepatocellular carcinoma (HCC) n = number of invasive procedures in patients with HCC PEI = percutaneous ethanol injection Less risk of seeding with tru-cut (insertion of fiducial marker resembles tru-cut more than end-cutting) Less risk of seeding with fine needle Source: Chang S, Kim SH, Lim HK, et al. Needle Tract Implantation After Sonographically Guided Percutaneous Biopsy of Hepatocellular Carcinoma: Evaluation of Doubling Time, Frequency, and Features on CT. AJR Am J Roentgenol. 005;185(): Source: Tung WC, Huang YJ, Leung SW, et al. Incidence of needle tract seeding and responses of soft tissue metastasis by hepatocellular carcinoma postradiotherapy. Liver International, vol. 7, no., pp , 007.

9 Less risk of seeding of cancer cells lower risk than with FNAC Insertion of marker Withdrawal of needle During fine-needle aspiration cytology (FNAC) the needle is moved back and forth in the lesion several times FNAC Many times The FNAC needle contains malignant cells that may leak out during withdrawal of the needle FNAC Insertion of Gold Anchor involves only one insertion and withdrawal of the needle Gold Anchor Once The stylet that pushes out the Gold Anchor marker fills the needle during withdrawal Gold Anchor Gold Anchor insertion is less traumatic than FNAC Gold Anchor needle withdrawal gives lower risk of seeding than FNAC 9