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Given the growing incidence of pleural effusions and the limited availability of medical thoracoscopy (MT) in clinical practice, ultrasound (US)-guided pleural needle biopsies using Abrams or cutting needles are increasingly being used for the histopathological diagnosis of pleural diseases. To assessed the diagnostic yield and safety of US-guided Abrams and cutting needles to determine the optimal needle type for specific clinical situations. Prospective randomized study. The study included 174 patients with undiagnosed pleural effusion requiring histopathological evaluation. Patients were randomized into two arms: those who underwent US-guided cutting needle biopsy (US-CNPB) and those who underwent US-guided Abrams needle biopsy (US-ANPB). The US-CNPB group exhibited a false-negative rate of 36.9% and diagnostic accuracy of 63.0%. compared to 21.3% and 78.7% in the US-ANPB group, with significant differences between the groups ( = 0.036 and 0.045, respectively). In patients with pleural thickening < 1 cm or absent on US, US-CNPB exhibited 55.2% diagnostic accuracy and a negative likelihood ratio (-LR) of 0.57. For US-ANPB, the corresponding rates were 77.3% and 0.32. The difference in diagnostic accuracy between the two groups was significant ( = 0.009). In patients with pleural thickening ≥ 1 cm, the diagnostic accuracy of US-CNPB was 93.3% and 88.9% for US-ANPB, with no significant difference between the groups. The corresponding -LR values were 0.08 and 0.17. In patients with pleural thickening < 1 cm, four major bleeding events (6.9%) occurred in the US-CNPB group. No deaths were reported in this study. US-CNPB should be preferred in patients with pleural thickness ≥ 1 cm on US. MT is recommended for patients with pleural thickening < 1 cm or those presenting with pleural effusion without pleural thickening. However, in the absence of MT, US-ANPB is the preferred alternative because of its superior diagnostic accuracy and procedural safety.

Ultrasound-guided fine-needle aspiration biopsy (FNAB) is essential for evaluating thyroid nodules but often yields inadequate samples, leading to repeated procedures, increased discomfort, and higher costs. Previous non-randomized studies found promising results of spinal needles to improve diagnostic adequacy. Therefore, we conducted a multicenter randomized controlled trial to validate these findings. Between July 1st, 2021, and April 13th, 2023, patients with suspicious thyroid nodules were randomized to receive FNAB with either a 25G spinal needle or conventional needle. The primary outcome was the rate of adequate diagnostic cytology. Secondary outcomes included procedure-related pain, sensitivity and specificity of FNAB, and adverse events. A total of 359 patients (75.6% female), with a mean age of 59.7 years (range 23-94) were randomized. The rate of adequate diagnostic FNAB was 86.2% (156/181) for the spinal group compared to 84.8% (151/178) for the control group (OR 1.01; 95% CI: 0.95-1.08). The mean pain scale score was 4.0 (SD = 1.8) in the spinal group and 3.9 (SD = 2.0) in the control group (p = 0.40). No complications were observed in either group. We found a significantly better cytological adequacy rate of FNABs performed by physicians with more than four years of experience in the procedure (OR=1.07; 95% CI, 1.01-1.14). No significant improvement was found using spinal needles with a stylet compared to conventional needles. Given the significantly higher cost of spinal needles and comparable diagnostic outcomes, their routine use for thyroid FNAB is not recommended.

Abstract Introduction: Observational data suggest that the 19-gauge (G) needle for endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) offers a higher diagnostic yield than the 22-G needle in sarcoidosis. No randomized trial has compared the yield of the two needles. Methods: We randomized consecutive subjects with suspected sarcoidosis and enlarged thoracic lymph nodes to undergo EBUS-TBNA with either the 19-G or the 22-G needle. We compared the study groups for diagnostic sensitivity (primary outcome) assessed by the yield of granulomas in subjects finally diagnosed with sarcoidosis. We also compared the sample adequacy, difficulty performing the needle puncture assessed on a visual analog scale (VAS), the subject’s cough intensity on an operator-rated VAS, and procedure-related complications (secondary outcomes). Results: We randomized 150 (mean age, 43.0 years; 55% women) subjects and diagnosed sarcoidosis in 116 subjects. The diagnostic sensitivity of the 19-G needle (45/60, 75.0%) was not higher (p = 0.52) than the 22-G needle (39/56, 69.6%). We obtained adequate aspirates in 90.0% and 85.7% of subjects in the respective groups (p = 0.48). The operators had greater difficulty puncturing lymph nodes with the 19-G needle (p = 0.03), while the operator-assessed cough intensity was similar in the groups (p = 0.41). Transient hypoxemia was the only complication encountered during EBUS-TBNA (two subjects in either group). Conclusion: We did not find the 19-G needle superior to the 22-G in diagnostic sensitivity, specimen adequacy, or safety of EBUS-TBNA in sarcoidosis. Puncturing the lymph nodes was more difficult with the 19-G needle.

Core needle biopsy is a common medical procedure to obtain tissue samples with tissue architecture for pathological assessment. One prevalent method involves the use of spring-loaded core needle biopsy devices, or “biopsy guns”. Despite their intense motion dynamics when shot through tissue, possible cavitation activity has received limited attention. Cavitation bubbles imploding in biological environments are known for their mechanical effects on cells and tissue. In this study, visual and acoustic monitoring was applied to characterize and quantify cavitation phenomena around longitudinally or flexurally oscillating core needle biopsy needles, when immersed in deionized water or embedded in agarose-based tissue mimicking phantom. In water, we observed that cavitation was most prominent with side cut needle, but bubble activity was also present with front cut needle. In agarose, the intensity of the cavitation was found to decrease with increasing agarose concentration. Cavitation was still observed at 0.3% w/v agarose gel, but at 1.0% w/v gel, cavitation activity was essentially eliminated. Acoustic emission was observed with both needle types from audible to ultrasound ranges. The study suggests that cavitation as a physical mechanism can occur in operation of spring-loaded core needle biopsy devices in water and tissue-mimicking hydrogels and should be considered as an opportunity for the development of new in vivo applications related to the echogenicity of the cavitation bubbles in ultrasound imaging as well as considered as a physical mechanism for safety studies.

Background Gastrointestinal subepithelial lesions (SELs) range from benign to malignant. Endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) is used widely for pathological diagnosis of SELs. Early diagnosis and treatment are important because all Gastrointestinal stromal tumors (GISTs) have some degree of malignant potential. Diagnosing SELs with EUS-FNB is more difficult than diagnosing other tumors because an accurate diagnosis of GIST requires a sufficient tissue sample for immunostaining, which is part of the diagnostic protocol. Moreover, EUS-FNB is less accurate for diagnosis based on samples from SELs measuring ≤ 2 cm. However, our retrospective study showed that more than 50% of patients with SELs ≤ 2 cm were diagnosed as GIST. Therefore, EUS-FNB needles are required with adequate sampling in SELs measuring ≤ 2 cm. Previously, we conducted a retrospective single-center study of SELs measuring ≤ 2 cm, and reported that EUS-FNB with a Fork-tip needle was superior to that with a Franseen needle in that the former acquires sufficient sample. This multicenter comparative open-label superiority study is designed to verify whether a 22G Fork-tip needle is superior to a 22G Franseen needle with respect to sample acquisition. Methods/design Present study will randomly assign for 110 patients (55 in the Fork-tip needle group and 55 in the Franseen needle group) with SELs measuring ≤ 2 cm, all of whom are managed at one of the 10 participating endoscopic centers. The primary endpoint evaluates the superiority of a 22G Fork-tip needle over a 22G Franseen needle for collection of an adequate tissue specimen at the first puncture. The secondary endpoints compare successful puncture rate, procedure completion rate, number of adverse events, diagnostic suitability of the first puncture specimen for GIST, and the number of punctures required until adequate specimen collection. Discussion The outcomes may provide insight into the optimal needle choice for diagnosis of SELs ≤ 2 cm, thereby aiding development of practice guidelines. Present study is expected to promote early definitive diagnosis of GISTs, thereby increasing the number of cases that can receive curative treatment and improving prognosis. Trial registration Japan Registry of Clinical Trials (JRCT; trial registration: jRCTs052230144). Registered December 13, 2023. (URL; https://jrct.niph.go.jp/re/reports/detail/76858 ).

Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been specifically designed for collecting sufficient tissue specimens, clinical studies have indicated no clear difference in diagnostic performance between these novel needles and conventional puncture needles. Recently, a needle with Franseen geometry was developed specifically for EUS-FNA biopsy. Due to the characteristic shape of its tip, the Franseen needle is expected to be effective for scraping tissues, thus potentially increasing the diagnostic accuracy of EUS-FNA biopsy. We plan to carry out a prospective, multicenter, open-labeled, controlled trial to compare conventional and Franseen needles in terms of the diagnostic accuracy of EUS-FNA for evaluating the malignancy of pancreatic mass lesions. Methods/design The study will enroll 520 patients with pancreatic mass managed at any of 21 participating endoscopic centers. Lesion samples obtained using 22G conventional and Franseen needles will be assessed to compare the efficacy and safety of these two types of needles in EUS-FNA for evaluating the malignancy of mass lesions in the pancreas. Tissue samples will be fixed in formalin and processed for histologic evaluation. For the purpose of this study, only samples obtained with the first needle pass will be used for comparing the: (i) accuracy of the malignancy diagnosis, (ii) sensitivity and specificity for the malignancy diagnosis, (iii) procedure completion rate, (iv) sample cellularity, and (v) incidence of complications. Patient enrollment begins on July 17, 2018. Discussion The outcomes of this study may provide insight into the optimal needle choice for evaluating the malignancy of pancreatic solid lesions, thus aiding in the development of practice guidelines for pancreatic diseases. Trial registration University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000030634 . Registered on 29 December 2017. http://www.umin.ac.jp/ Version number: 01.2017.12.28.

PurposeBiopsy under the guidance of contrast-enhanced ultrasound is sometimes useful. Needle visualization in contrast-specific imaging-mode is often poor; however, it may be improved by priming the needles with an ultrasound contrast agent. This study aimed to evaluate needle priming methods using the ultrasound contrast agent sulfur hexafluoride and a 1 mL syringe.Material and MethodsTwo kinds of biopsy needles, side-notch and full core, and one kind of introducer needle were primed using non-primed needles as controls (n = 180). Recordings of punctures were performed in a water bath phantom to which the ultrasound contrast agent had also been added. Contrast-specific imaging-mode needle visibility was evaluated for the entire needles and the needle tips, respectively, quantitatively by calculating the contrast-to-noise ratio and qualitatively via grading by three radiologists.ResultsThe contrast-to-noise ratio following the ultrasound contrast agent priming was superior compared to the controls for the entire needles of all three types (p < 0.001) and for the needle tips of the core biopsy needles and introducer needles (p < 0.001). However, the ratio was equal to the controls for the needle tips of the side-notch biopsy needles (p = 0.19). Needle visibility following the ultrasound contrast agent priming was qualitatively superior compared to the controls for both the entire needles and the needle tips, and the difference was considered clinically relevant by the assessors (p < 0.001).ConclusionThe ultrasound contrast agent needle priming methods described increased the contrast-specific imaging-mode needle visibility in a phantom model. Nonetheless, the results also need to be confirmed in vivo.

Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography-guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear. In this multicenter, randomized, parallel-group, noninferiority trial, we assigned patients with an intermediate-risk or high-risk peripheral pulmonary nodule measuring 10 to 30 mm in diameter to undergo navigational bronchoscopy or transthoracic needle biopsy at seven centers across the United States. The primary outcome was diagnostic accuracy, which was defined as the percentage of patients with biopsies that showed a specific diagnosis (cancer or a specific benign condition) that was confirmed to be accurate through 12 months of clinical follow-up (nonferiority margin, 10 percentage points). Secondary outcomes included procedural complications such as the occurrence of pneumothorax. Among the 234 patients included in the primary-outcome analysis (5 of whom were lost to follow-up), biopsy resulted in a specific diagnosis that was confirmed to be accurate through month 12 in 94 of 119 patients (79.0%) in the navigational bronchoscopy group and in 81 of 110 patients (73.6%) in the transthoracic needle biopsy group (absolute difference, 5.4 percentage points; 95% confidence interval, -6.5 to 17.2; P = 0.003 for noninferiority; P = 0.17 for superiority). Pneumothorax occurred in 4 of 121 patients (3.3%) in the navigational bronchoscopy group and in 32 of 113 patients (28.3%) in the transthoracic needle biopsy group and led to the placement of a chest tube, hospital admission, or both in 1 patient (0.8%) and 13 patients (11.5%), respectively. The diagnostic accuracy of navigational bronchoscopy was noninferior to that of transthoracic needle biopsy among patients with peripheral pulmonary nodules measuring 10 to 30 mm. (Funded by Medtronic and others; VERITAS ClinicalTrials.gov number, NCT04250194.).

BackgroundIn a tertiary center setting we aimed to study the diagnostic accuracy and clinical impact of EUS-guided biopsy sampling (EUS-FNB) with a reverse bevel needle compared with that of fine needle aspiration (EUS-FNA) in the work-up of subepithelial lesions (SEL).MethodsAll patients presenting with SELs referred for EUS-guided sampling were prospectively included in 2012–2015. After randomization of the first pass modality, dual sampling with both EUS-FNB and EUS-FNA was performed in each lesion. Outcome measures in an intention-to-diagnose analysis were the diagnostic accuracy, technical failures, and adverse events. The clinical impact was measured as the performance of additional diagnostic procedures post-EUS and the rate of unwarranted resections compared with a reference cohort of SELs sampled in the same institution 2006–2011.ResultsIn 70 dual sampling procedures of unique lesions (size: 6–220 mm) the diagnostic sensitivity for malignancy and the overall accuracy of EUS-FNB was superior to EUS-FNA compared head-to-head (90 vs 52%, and 83 vs 49%, both p < 0.001). The adverse event rate of EUS-FNB was low (1.2%). EUS-FNB in 2012–2015 had a positive clinical impact in comparison with the reference cohort demonstrated by less cases referred for an additional diagnostic procedure, 12/83 (14%) vs 39/73 (53%), p < 0.001, and fewer unwarranted resections in cases subjected to surgery, 3/48 (6%) vs 12/35 (34%), p = 0.001.ConclusionsEUS-FNB with a reverse bevel needle is safe and superior to EUS-FNA in providing a conclusive diagnosis of subepithelial lesions. This biopsy sampling approach facilitates a rational clinical management and accurate treatment.

Background The management of breast disease has been greatly facilitated by the technology of needle biopsy interventions, and over the past 30 years, this has evolved from the use of fine-needle aspiration biopsy (FNAB) to the current methodology of vacuum assisted biopsy (VAB). Methods This article provides an historical review of the application of needle interventions of the breast in the diagnosis and management of breast conditions, and discusses current indications for the use of vacuum assisted biopsies and vacuum assisted excisions. Results Whilst FNAB continues to have a limited role in breast disease diagnosis, the necessity of achieving an histological diagnosis has preferentially seen the development and wider application of automated core needle biopsies (CNB) and VAB in the assessment and management of breast lesions. The advantages of CNB and VAB include the ability to distinguish in situ and invasive disease pre-operatively, and the ability to achieve prior knowledge of immunohistochemical tumour markers particularly in the setting of neoadjuvant drug treatments. Conclusion Due to its ability to obtain larger tissue samples, VAB does have diagnostic advantages over CNB and indications for the utilization of VAB are discussed. VAB additionally has an expanding role as a tool for breast lesion excision.