Evaluation of 19-gauge endoscopic ultrasonography aspiration needles using various echoendoscopes.
ABSTRACT: BACKGROUND AND STUDY AIMS: 19-gauge (19G) needles are used for EUS-guided tissue acquisition and interventions. The aim of the current study was to compare the functional characteristics of 19G EUS needles by means of using various echoendoscopes in a bench simulator. METHODS: The angles achieved for 19G needles (EchoTip: ET-19G, EchoTip Flex: ExF-19G, Expect: Ex-19G, and ProCore: PC-19G) and for the distal tip of the echoendoscope were evaluated for maximal angulation settings of the distal tip and the elevator. Also the resistance to advancement of the 19G needles at these endoscope settings was assessed. All evaluations were done with endoscopes in a straight and in a curved position. RESULTS: There was no large discrepancy for scope and needle angles among all echoendoscopes except for the slim Pentax scope (EG-3270UK). The ExF-19G and PC-19G needles showed better optimal angles in various conditions compared to standard 19G needles. In straight scope position, out of the 20 conditions (5 endoscopes × 2 positions of the distal tip × 2 elevator positions) the numbers of optimal angulations achieved for the Ex-19G, ExF-19G, ET-19G, and PC-19G, were 11 /20 (55 %), 20 /20 (100 %), 14 /20 (70 %) and 18 /20 (90 %), respectively. However, regarding resistance, it was impossible to advance theneedle with 14 /20 settings (70 %) for the Ex-19G, 3 /20 (15 %) for the ExF-19G, 10 /20 (50 %) for the ET-19G and 7 /20 (35 %) for the PC-19G. When the scopes were bent, with regard to the force needed to advance the needle, the numbers of optimal settings, for the Ex-19G, ExF-19G, ET-19G, and PC-19G, were 1 (5 %), 13 (65 %), 6 (30 %) and 8 (40 %), respectively. The mean maximum resistance to advancement was less for the ExF-19G than for the other needless in almost all scope and angle conditions (p < 0.05). CONCLUSION: Although there was no difference between needles, the resistance to passage was least with the flexible 19-gauge needle (ExF-19G).
Project description:EUS-guided FNA or biopsy sampling is widely practiced. Optimal sonographic visualization of the needle is critical for image-guided interventions. Of the several commercially available needles, bench-top testing and direct comparison of these needles have not been done to reveal their inherent echogenicity. The aims are to provide bench-top data that can be used to guide clinical applications and to promote future device research and development.Descriptive bench-top testing and comparison of 8 commonly used EUS-FNA needles (all size 22 gauge): SonoTip Pro Control (Medi-Globe); Expect Slimline (Boston Scientific); EchoTip, EchoTip Ultra, EchoTip ProCore High Definition (Cook Medical); ClearView (Conmed); EZ Shot 2 (Olympus); and BNX (Beacon Endoscopic), and 2 new prototype needles, SonoCoat (Medi-Globe), coated by echogenic polymers made by Encapson. Blinded evaluation of standardized and unedited videos by 43 EUS endoscopists and 17 radiologists specialized in GI US examination who were unfamiliar with EUS needle devices.There was no significant difference in the ratings and rankings of these needles between endosonographers and radiologists. Overall, 1 prototype needle was rated as the best, ranking 10% to 40% higher than all other needles (P < .01). Among the commercially available needles, the EchoTip Ultra needle and the ClearView needle were top choices. The EZ Shot 2 needle was ranked statistically lower than other needles (30%-75% worse, P < .001).All FNA needles have their inherent and different echogenicities, and these differences are similarly recognized by EUS endoscopists and radiologists. Needles with polymeric coating from the entire shaft to the needle tip may offer better echogenicity.
Project description:Although a large gauge needle can procure more tissue at endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), its advantage over smaller needles is unclear. This study compared flexible 19G and 25G needles for EUS-FNA of solid pancreatic masses.This was a randomized trial of patients undergoing EUS-FNA of pancreatic masses using flexible 19G or 25G needle. Main outcome measure was to compare median number of passes for on-site diagnosis. Secondary measures were to compare specimen bloodiness, complications, technical failures, and histological core tissue procurement.One hundred patients were randomized to EUS-FNA using flexible 19G or 25G needle. Median of 1 pass was required to achieve on-site diagnosis of 96% and 92% (P = 0.68) in 19G and 25G cohorts. There was no significant difference in technical failure (0% vs 2%, P = 0.99) or adverse events (2% vs 0%, P = 0.99) between 19G and 25G cohorts. Although histological core tissue procurement was significantly better with flexible 19G needle (88% vs 44%, P < 0.001), specimens were bloodier (severe bloodiness, 36% vs 4%; P < 0.001).As there is no significant difference in the performance of flexible 19G and 25G needles, needle choice for sampling pancreatic masses should be based on endoscopist preference and need for histology.
Project description:To compare the aspiration needle (AN) and core biopsy needle (PC) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of abdominal masses.Consecutive patients referred for EUS-FNA were included in this prospective single-center trial. Each patient underwent a puncture of the lesion with both standard 22-gauge (G) AN (Echo Tip Ultra; Cook Medical, Bloomington, Indiana, United States) and the novel 22G PC (EchoTip ProCore; Cook Medical, Bloomington, Indiana, United States) in a randomized fashion; histology was attempted in the PC group only. The main study endpoint was the overall diagnostic accuracy, including the contribution of histology to the final diagnosis. Secondary outcome measures included material adequacy, number of needle passes, and complications.Fifty six consecutive patients (29 men; mean age 68 years) with pancreatic lesions (n = 38), lymphadenopathy (n = 13), submucosal tumors (n = 4), or others lesions (n = 1) underwent EUS-FNA using both of the needles in a randomized order. AN and PC reached similar overall results for diagnostic accuracy (AN: 88.9 vs PC: 96.1, P = 0.25), specimen adequacy (AN: 96.4% vs PC: 91.1%, P = 0.38), mean number of passes (AN: 1.5 vs PC: 1.7, P = 0.14), mean cellularity score (AN: 1.7 vs PC: 1.1, P = 0.058), and complications (none). A diagnosis on the basis of histology was achieved in the PC group in 36 (64.3%) patients, and in 2 of those as the sole modality. In patients with available histology the mean cellularity score was higher for AN (AN: 1.7 vs PC: 1.0, P = 0.034); no other differences were of statistical significance.Both needles achieved high overall diagnostic yields and similar performance characteristics for cytological diagnosis; histological analysis was only possible in 2/3 of cases with the new needle.
Project description:Endobronchial ultrasound has become the first choice standard of care procedure to diagnose benign or malignant lesions involving mediastinum and lung parenchyma adjacent to the airways owing to its characteristics of being real-time and minimally invasive. Although the incidence of lung cancer has been decreasing, it is and will be the leading cause of cancer-related mortality in the next few decades. When compared to other cancers, lung cancer kills more females than breast and colon cancers combined and more males than colon and prostate cancers combined. The type of lung cancer has changed in recent decades and adenocarcinoma has become the most frequent cell type. Prognosis of lung cancer depends upon the cell type and the staging at the time of diagnosis. The cell type and molecular characteristics of adenocarcinoma may allow individualized targeted treatment. Other malignant conditions in the mediastinum and lung (eg, metastatic lung cancers and lymphoma) can be biopsied using endobronchial ultrasound needles. Endobronchial ultrasound needle biopsies provides mostly cytology specimens due to its small sizes of needles (22 gauge or larger) which may not give enough tissue to make a definitive diagnosis in malignant (eg, lymphoma) or benign conditions (eg, sarcoidosis). EchoTip ProCore endobronchial needle released in early 2014 provides histologic biopsy material. Larger tissue biopsies may potentially provide a higher diagnostic yield and it eliminates mediastinoscopy or other surgical interventions. Here we aim to review bronchoscopic approach in the diagnosis of mediastinal lesions with emphasis of EchoTip ProCore needles.
Project description:Background and Objective:EUS-guided fine-needle biopsy has become the standard for tissue sampling. A new 20G ProCore™ (PC) needle has been developed to overcome the limitations of tissue acquisition of the smaller needles (22G, 25G) and the rigidity of the larger one (19G). The aim of this study is to assess the performance of the 20G PC needle. Materials and Methods:Patients who underwent EUS-guided tissue acquisition with the 20G PC needle of pancreatic and extra-pancreatic mass lesions were retrospectively identified at three Italian centers (Bologna, Fermo, and Palermo). Diagnostic adequacy, accuracy, and tissue core acquisition were the outcome measures. All the cases were performed without rapid on-site evaluation. Results:A total of 384 patients with pancreatic (62.2%) and extra-pancreatic lesions were included in the study. For pancreatic lesions, adequacy, accuracy, sensitivity, and specificity were 92.4%, 91.5%, 90.8%, and 100%, respectively, with a number needed to misdiagnose (NNM) of 11.8. The tissue core was obtained in 72% of cases. Transduodenal approach was performed in 150 pancreatic lesions; adequacy, accuracy, and tissue core acquisition were 88.7%, 90%, and 66%, respectively (NNM 10). For extrapancreatic lesions, adequacy, accuracy, sensitivity, specificity, and tissue core sampling were 95.3%, 95.3%, 92.6%, 100%, and 84.5% (NNM 21.3). Conclusions:The 20G PC needle showed high diagnostic adequacy and accuracy, regardless the access route.
Project description:<h4>Background</h4>Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) is a standard method for pathological diagnosis of pancreatic solid lesions. The EchoTip ProCore 20G® (PC20), a 20-gauge biopsy needle with a forward-bevel core trap, has been available in Japan since 2015.<h4>Methods</h4>We compared the efficacy of the PC20 with that of the EchoTip ProCore 22G® (PC22) and Acquire 22G® (AC22) in EUS-FNA/B for diagnosing pancreatic cancer. This retrospective study included 191 patients with pancreatic cancer who underwent EUS-FNA/B using the PC20, PC22, or AC22 at our facility from April 2013 to October 2019. We investigated the patients' clinical characteristics and the diagnostic accuracy and safety of each needle.<h4>Results</h4>A sufficient stroke length of puncture was secured in all patients. The maximum length under EUS was shorter with the AC22 (22.1?±?2.2 mm) than PC20 (30.6?±?0.7 mm, p?<?0.01) and PC22 (30.3?±?0.8 mm, p?<?0.01). The histological accuracy was 96.4% with the PC20 but only 58.8% with the PC22 (adjusted p (p-adj)?<?0.0001) and 75.0% with the AC22 (p-adj?=?0.06). The diagnostic accuracy of the combination of histology and cytology was 96.4% with the PC20, while it was 72.1% with the PC22 (p-adj?<?0.0001) and 91.7% with the AC22 (p-adj?>?0.99). One patient (0.9%) in the PC20 group developed mild pancreatitis, but no adverse events occurred with the other needles.<h4>Conclusions</h4>The PC20 showed better diagnostic capability than the PC22. The diagnostic efficacy was similar between the PC20 and AC22. The high histological accuracy of the PC20 could be advantageous for lesions in which histological assessment is critical.
Project description:Background and study aims? Endoscopic ultrasound-guided liver biopsy uses a 19-gauge (G) needle for parenchymal liver biopsies. We evaluated tissue yields with a 22G fine-needle biopsy (FNB) versus 19G FNA fine-needle aspirate (FNA) device. Patients and methods? Biopsies were obtained from 20 patients using the 19G FNA and 22G FNB randomizing each in a cross-over fashion with a blinded outcome assessor. Tissue adequacy for histologic evaluation was the primary outcome, or the proportion of specimens obtaining pathologic diagnosis (portal structures ??5 or length of the longest piece ??15?mm). Additional secondary outcomes included portal and centrilobular inflammation/fibrosis, length of the longest piece, aggregate specimen length, and small (<?5?mm), medium (5?-?8?mm) and large (>?8?mm) fragments. Results were compared in a per needle basis. Patients with cirrhosis were excluded. Results? Eighty biopsies (40 each 19G FNA and 22G FNB) were obtained. Tissue adequacy was greater for the 19G FNA (88?%) versus 22G FNB (68?%), ( P ?=?0.03). There was no difference in total portal structures for the 19G FNA (7.4) and 22G FNB (6.1), ( P ?=?0.28). There was no difference in pre-processing outcomes. After processing, length of the longest piece was higher for the 19G FNA (9.1?mm) versus 22G FNB (6.6?mm), ( P ?=?0.02). More total post-processing small fragments 29.9 versus 20.7, ( P ?=?0.01) and fewer large fragments 1.0 versus 0.4 for the 22G FNB ( P ?=?0.01) were detected. Conclusions? Tissue adequacy was higher for the 19G FNA versus 22G FNB needle. The 22G FNB needle produced samples more prone to fragmentation during specimen processing.
Project description:Sore, infected wounds are a major clinical issue, and there is thus an urgent need for novel biomaterials as multifunctional constituents for dressings. A set of biocomposites was prepared by solvent casting using different concentrations of carboxymethylcellulose (CMC) and exfoliated graphene oxide (Exf-GO) as a filler. Exf-GO was first obtained by the strong oxidation and exfoliation of graphite. The structural, morphological and mechanical properties of the composites (CMCx/Exf-GO) were evaluated, and the obtained composites were homogenous, transparent and brownish in color. The results confirmed that Exf-GO may be homogeneously dispersed in CMC. It was found that the composite has an inhibitory activity against the Gram-positive Staphylococcus aureus, but not against Gram-negative Pseudomonas aeruginosa. At the same time, it does not exhibit any cytotoxic effect on normal fibroblasts.
Project description:Camera-guided instruments, such as endoscopes, have become an essential component of contemporary medicine. The 15-20 million endoscopies performed every year in the United States alone demonstrate the tremendous impact of this technology. However, doctors heavily rely on the visual feedback provided by the endoscope camera, which is routinely compromised when body fluids and fogging occlude the lens, requiring lengthy cleaning procedures that include irrigation, tissue rubbing, suction, and even temporary removal of the endoscope for external cleaning. Bronchoscopies are especially affected because they are performed on delicate tissue, in high-humidity environments with exposure to extremely adhesive biological fluids such as mucus and blood. Here, we present a repellent, liquid-infused coating on an endoscope lens capable of preventing vision loss after repeated submersions in blood and mucus. The material properties of the coating, including conformability, mechanical adhesion, transparency, oil type, and biocompatibility, were optimized in comprehensive in vitro and ex vivo studies. Extensive bronchoscopy procedures performed in vivo on porcine lungs showed significantly reduced fouling, resulting in either unnecessary or ?10-15 times shorter and less intensive lens clearing procedures compared with an untreated endoscope. We believe that the material developed in this study opens up opportunities in the design of next-generation endoscopes that will improve visual field, display unprecedented antibacterial and antifouling properties, reduce the duration of the procedure, and enable visualization of currently unreachable parts of the body, thus offering enormous potential for disease diagnosis and treatment.
Project description:The gastrointestinal tract is a challenging anatomical target for diagnostic and therapeutic procedures for bleeding, polyps and cancerous growths. Advanced endoscopes that combine imaging and therapies within the gastrointestinal tract provide an advantage over stand-alone diagnostic or therapeutic devices. However, current multimodal endoscopes lack the spatial resolution necessary to detect and treat small cancers and other abnormalities. Here we present a multifunctional endoscope-based interventional system that integrates transparent bioelectronics with theranostic nanoparticles, which are photoactivated within highly localized space near tumours or benign growths. These advanced electronics and nanoparticles collectively enable optical fluorescence-based mapping, electrical impedance and pH sensing, contact/temperature monitoring, radio frequency ablation and localized photo/chemotherapy, as the basis of a closed-loop solution for colon cancer treatment. In vitro, ex vivo and in vivo experiments highlight the utility of this technology for accurate detection, delineation and rapid targeted therapy of colon cancer or precancerous lesions.