22G versus 25G biopsy needles for EUS-guided tissue sampling of solid pancreatic masses: a randomized controlled study

Background/Objectives: No comparative study of 22-gauge biopsy needles (PC22) and 25-gauge biopsy needles (PC25) has been conducted. We prospectively compared the diagnostic accuracy of PC22 and PC25 in patients with pancreatic and peripancreatic solid masses.

Methods: We conducted a randomized noninferiority clinical study from January 2013 to May 2014 at Samsung Medical Center. A cytological and histological specimen of each pass was analyzed separately by an experienced pathologist. The primary outcome was to assess the diagnostic accuracy using the PC22 or PC25. Secondary outcomes included the optimal number of passes for adequate diagnosis, core specimen yield, sample adequacy, and complication rates.

Results: Diagnostic accuracy of combining cytology with histology in three cumulative passes was 97.1% (100/103) for the PC22 and 91.3% (94/103) for the PC25 group. Thus, noninferiority of PC25 to PC22 was not shown with a 10% noninferiority margin (difference, ?5.8%; 95% CI, ?12.1 to ?0.5%). In a pairwise comparison with each needle type, two passes was non-inferior to three passes in the PC22 (96.1% vs. 97.1%; difference, ?0.97%; 95% CI ?6.63 to 4.69%) but noninferiority of two passes to three passes was not shown in the PC25 group (87.4% vs. 91.3%; difference, ?3.88%; 95% CI, ?13.5 to 5.7%).

Conclusions: Non-inferiority of PC25 to PC22 diagnostic accuracy was not observed for solid pancreatic or peripancreatic masses without on-site cytology. PC22 may be a more ideal device because only two PC22 needle passes was sufficient to establish an adequate diagnosis, whereas PC25 required three or more needle passes.     

22-Gauge biopsy needles have a better histological diagnostic yield in the discrimination of specific pancreatic solid neoplasms

Background: To overcome the limitations of using cytological specimen alone for the diagnosis of challenging pancreatic lesions, biopsy needles have been developed to procure histological specimens during EUS, especially for the discrimination of several specific pancreatic tumors requiring adequate histological samples. The aim of this study was to compare the diagnostic yield of EUS-guided 22-gauge (G) fine needle aspiration (FNA) needles and 22G fine needle biopsy (FNB) needles for sampling pancreatic masses.

Methods: We conducted a retrospective study of all EUS-guided sampling performed between November 2012 and April 2016. 422 cases sampled with a 22G FNA needle (N?=?254) or a 22G FNB needle (N?=?168) were recruited for this study. The specimen quality analyses, technical characteristics, accuracy, sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs) for the pancreatic masses were reviewed and compared.

Results: There was no significant difference in the procurement of adequate histological specimens (75.0% vs. 79.5%; p?=?.277) or the presence of diagnostic histological specimens (71.3% vs. 77.4%; p?=?.155) between FNA and FNB groups, respectively. There were also no significant differences in the accuracy, sensitivity, specificity, PPVs, or NPVs of the cytological, histological, and overall analyses for FNA and FNB groups in the diagnosis of pancreatic malignancy. However, 22G biopsy needles demonstrated a better histological diagnostic yield in the discrimination of pancreatic adenocarcinoma and non-adenocarcinoma pancreatic neoplasms than 22G FNA needles (69.8% vs. 57.9%, p?=?.033).

Conclusions: 22G FNB needle demonstrated a better histological diagnostic yield in the differentiation between pancreatic adenocarcinoma and non-adenocarcinoma pancreatic neoplasms.     

EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study

Background and aimEndoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle.MethodsObservational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events.Results100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03–0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events.ConclusionThe new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.     

Value of endoscopic ultrasound guided fine needle aspiration biopsy in the diagnosis of solid pancreatic masses

AIM: To assess the feasibility and diagnostic accuracy of endoscopic ultrasound guided fine needle biopsy (EUS-FNAB) in patients with solid pancreatic masses. METHODS: Ninety nine consecutive patients with pancreatic masses were studied. Histological findings obtained by EUS-FNAB were compared with the final diagnosis assessed by surgery, biopsy of other tumour site or at postmortem examination, or by using a combination of clinical course, imaging features, and tumour markers. RESULTS: EUS-FNAB was feasible in 90 patients (adenocarcinomas, n = 59; neuroendocrine tumours, n = 15; various neoplasms, n = 6; pancreatitis, n = 10), and analysable material was obtained in 73. Tumour size (>/= or < 25 mm in diameter) did not influence the ability to obtain informative biopsy samples. Diagnostic accuracy was 74.4% (adenocarcinomas, 81.4%; neuroendocrine tumours, 46.7%; other lesions, 75%; p<0.02). Overall, the diagnostic yield in all 99 patients was 68%. Successful biopsies were performed in six patients with portal hypertension. Minor complications (moderate bleeding or pain) occurred in 5% of cases. CONCLUSIONS: EUS-FNAB is a useful and safe method for the investigation of pancreatic masses, with a high feasibility rate even when lesions are small. Overall diagnostic accuracy of EUS-FNAB seems to depend on the tumour type.     

Performance of a new histology needle for EUS-guided fine needle biopsy: A retrospective multicenter study

ObjectiveProcurement of tissue core biopsy may overcome some of the limitations of EUS-FNA. We aimed at assessing the safety, core procurement yield and diagnostic accuracy of two novel available histology needles.MethodsData from consecutive patients with solid lesions who underwent EUS-FNB using the 25G-22G SharkCore™ needles were retrieved from 4 tertiary-care centers database.Results146 patients (mean age 64 ± 12 years; M/F, 76/68) with 156 lesions (114 pancreatic) were identified. In 83 cases the 22G needle was used. 3.6 ± 1.2 passes per lesion were performed, without any major complications. A core biopsy was procured in 89.1% of cases. Considering malignant vs. non-malignant disease, the sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, and diagnostic accuracy were 90.2% (95% CI, 83.7–94.3), 100% (95% CI, 87.2–100), 0.099 (95% CI, 0.058–0.170), 60.4 (95% CI, 3.86–947.4), and 92.3% (95% CI, 88.1–96.5). Procurement yield was significantly higher for the 22G (95.2% vs. 82.2%, p = 0.011), despite the fact that more needle passes were performed with the 25G needle (3.8 ± 1.3 vs. 3.4 ± 1.0, p = 0.028).ConclusionsEUS-FNB using the 25G-22G SharkCore™ needles is able to reach a very good procurement yield and diagnostic accuracy. The 22G-size needle showed superior core procurement and diagnostic capabilities. Large prospective studies are warranted to further evaluate the use of these types of needles.     

超声内镜引导下细针穿刺活检对胰腺实性占位定性诊断价值的Meta分析

目的:系统评价超声内镜引导下细针穿刺活检(EUS-FNA)在胰腺实性占位定性诊断中的价值.方法:计算机检索MEDLINE、Cochrane Library、中国生物医学文献数据库、万方数据库、中国学术期刊全文等数据库,检索时间均为建库至2011-10.全面查找有关EUS-FNA诊断胰腺实性占位的文献,按照诊断试验的纳入标准筛选文献,提取纳入文献的特征信息(研究背景、设计信息和诊断参数信息),根据QUADAS质量评价标准纳入文献的质量.采用Meta-Disc1.4软件进行Meta分析,检验异质性,并根据异质性结果选择相应的效应模型.对纳入文献予以加权定量合并,计算汇总敏感度、特异度、阳性似然比、阴性似然比和诊断优势比及其95%CI,绘制汇总受试者工作特征(SROC)曲线,并计算曲线下面积(AUC).结果:共检索出相关文献280篇,按照文献纳入标准,最终纳入18篇文献(均为英文文献).EUS-FNA对胰腺实性占位定性诊断价值分别为:汇总敏感度为0.90[95%CI(0.89-0.92)],汇总特异度为0.95[95%CI(0.93-0.97)],汇总阳性似然比为13.56[95%CI(8.31-22.15)],汇总阴性似然比为0.12[95%CI(0.10-0.15)],汇总诊断优势比为143.62[95%CI(93.98-219.46)],SROC曲线下面积AUC为0.9711,Q*=0.9215.另外,本研究还对有无病理医生在场指导进行了亚组分析,发现有病理医生在场的AUC为0.9757,Q*=0.9295.且汇总诊断优势比173.37[95%CI(98.09-306.44)],明显较无病理医生在场的113.64[95%CI(60.22-214.46)]高.结论:经SROC曲线证实,EUS-FNA活检在胰腺实性占位定性诊断中具有较高的灵敏度和特异度,尤其是有病理医生在场指导的情况下,可作为临床上胰腺实性占位定性诊断的重要检查手段.     

Diagnosis of mediastinal cysts: the role and safety of EUS–FNA with 19-gauge needle: a retrospective cohort study

BackgroundMediastinal cysts are uncommon, and their diagnosis remains a clinical challenge, especially for patients with a solid mass on computed tomography (CT). Endoscopic ultrasound (EUS) is considered a valuable method to differentiate mediastinal cysts and EUS-fine needle aspiration (FNA) is a strategy for obtaining specimens from the cysts for cytological diagnosis. This study aims to evaluate the safety and utility of EUS-FNA for diagnosis of mediastinal cysts.MethodsThis was a retrospective analysis of patients who underwent EUS-FNA with 19-gauge needle at Tianjin Medical University Cancer Institute and Hospital and were further diagnosed with mediastinal cysts confirmed by cytological and surgical pathological results between January 2016 and December 2020. Safety was estimated by the incidence of reported adverse events (AEs). Patients were followed for 48 hours and 1 week after the EUS-FNA procedure to evaluate AEs.ResultsA total of 20 patients were diagnosed with mediastinal cysts using EUS-FNA, yet only 5 were diagnosed by CT. There were 15 patients diagnosed with bronchogenic cyst, 4 with enteric cyst, and 1 with pericardial cyst. The EUS appearance of cyst content varied, ranging from anechoic (4 cases) to hypoechoic (16 cases). AEs occurred in 2/20 (10%) patients after the EUS-FNA indicating an acceptable low rate of AEs. For all anechoic cysts that underwent complete FNA drainage, 3 patients had good prognosis, whereas 1 experienced recurrence. For 16 patients with hypoechoic cysts, adequate tissue was obtained for cytological examination. No patient developed an infection-related complication.ConclusionsFor the diagnosis of mediastinal cysts, EUS-FNA was more accurate than CT. The EUS-FNA of mediastinal cysts is safe with an acceptable low rate of AEs when antibiotic prophylaxis is used postoperatively. Cysts containing free-flowing fluid can be achieved with complete needle drainage by a single pass with a 19-gauge needle.     

Comparison of 22-gauge standard fine needle versus core biopsy needle for endoscopic ultrasound-guided sampling of suspected pancreatic cancer: a randomized crossover trial

Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is effective for tissue diagnosis of pancreatic mass. To improve diagnostic yield and drawbacks, 22-gauge (G) core biopsy (FNB) needle has been developed. This study aims to compare 22G FNA and FNB needles for EUS-guided sampling of suspected pancreatic cancer.

Methods: This is a randomized controlled crossover trial. A total of 60 patients with suspected unresectable pancreatic cancer referred for EUS-guided sampling were randomly assigned to two groups. Both groups had 22G FNA and FNB needles performed in a randomized order. The primary endpoint was the cytological, histological and overall diagnostic accuracy of pancreatic cancer.

Results: FNA and FNB needles reported similar level of diagnostic accuracy (FNA needle 95% vs. FNB needle 93.3%; p?=?.564), and it was not statistically different. However, cytological cellularity was significantly higher in the FNB needles compared to FNA needles (odds ratio 2.75, 95% confidence interval (CI)). There were no procedure-related complications in both needles.

Conclusions: The diagnostic accuracy of EUS-guided sampling for pancreatic cancer using 22G FNA is comparable to FNB needles. The cytological quality of specimen is better in the FNB needle.     

EUS-guided fine needle tissue acquisition by using high negative pressure suction for the evaluation of solid masses: a pilot study

BACKGROUND: The capability of obtaining tissue samples for histologic examination during EUS has theoretical advantages over cytology alone. The objective was to evaluate the feasibility and the yield of EUS-guided FNA tissue acquisition (EUS-FNTA) by using high negative pressure suction. METHODS: The study design is a prospective, observational pilot study set at a tertiary referral center. Twenty-seven patients with a solid mass amenable to sampling with EUS were included in the study. FNA with a 22-gauge needle was used for a total of 5 passes. An additional pass with the same needle was performed by applying continuous high negative pressure suction using the Alliance II inflation system. The main outcome measurements were the rate of tissue acquisition and the diagnostic accuracy of EUS-FNTA. OBSERVATIONS: Tissue samples were obtained in 26 of the 27 patients (96%). Malignancy was detected in 20 of the 26 biopsy specimens obtained by FNTA and in 20 of the 27 FNA specimens. In 3 patients, EUS-FNTA failed to disclose malignancy, which in two of the patients was diagnosed by FNA. Conversely, EUS-FNTA diagnosed a recurrent malignant thymoma and a schwannoma in two FNA-negative patients. In 3 patients with both FNTA and FNA negative for malignancy, a definitive diagnosis could not be established. Overall, diagnostic accuracy was 76.9% for both EUS-FNTA and EUS-FNA. When combined, a correct diagnosis was achieved in 84.6% of the patients. Immunostaining of the retrieved tissue allowed characterization of the primary tumor in 5 cases and the diagnosis of a schwannoma and two neuroendocrine tumors. Limitations of the study were small sample size and a pilot study. CONCLUSIONS: EUS-FNTA has a high yield for the retrieval of core tissue samples. Further studies in which EUS-FNTA is performed before FNA and with variable number of passes are needed to better define its diagnostic role and performance characteristics.     

Prospective evaluation of the optimal number of 25‐gauge needle passes for endoscopic ultrasound‐guided fine‐needle aspiration biopsy of solid pancreatic lesions in the absence of an onsite cytopathologist

Introduction: A prior study with 22‐gauge needles recommended more than seven needle passes for endoscopic ultrasound‐guided fine‐needle aspiration biopsy (EUS‐FNA) of solid pancreatic lesions (SPL) without onsite cytopathology for optimal acquisition of cytopathological diagnosis. The feasibility of this recommendation should be re‐evaluated considering the later development and popularity of 25‐gauge EUS‐FNA needles. We aimed to determine the optimal number of needle passes for cytopathological specimen acquisition with 25‐gauge needles for EUS‐FNA of SPL. Methods: A preliminary prospective study of 22 patients with an onsite cytopathology technician showed a sensitivity of 93.3% and a specificity of 100% with four needle passes that was not statistically different from five needle passes. Based on our preliminary study, we fixed the number of needle passes to four (Group A). As a control group, we carried out sampling in consecutive patients using 25‐gauge needles with an onsite cytopathologist (Group B). Sampling rate, diagnostic value and complications were evaluated. Results: We enrolled 20 patients in each group. Sampling rate was higher in Group B (20/20, 100%) than in Group A (19/20, 95%), but there was no statistical difference between them (P‐value = 0.31). In Group A, sensitivity, specificity and accuracy were 100% among 19. In Group B, sensitivity was 94.1%, specificity 100%, accuracy 95%. There were also no statistical differences between the groups. No complications were seen. Conclusion: Our study suggests that four needle passes using a 25‐gauge needle may be sufficient for EUS‐FNA of SPL where onsite cytology is not available.     

Newly-developed, forward-viewing echoendoscope: a comparative pilot study to the standard echoendoscope in the imaging of abdominal organs and feasibility of endoscopic ultrasound-guided interventions

Background and Aim: Multiple diagnostic and therapeutic endoscopic ultrasound (EUS) procedures have been widely performed using a standard oblique‐viewing (OV) curvilinear array (CLA) echoendoscope. Recently, a new, forward‐viewing (FV) CLA was developed, with the advantages of improved endoscopic viewing and manipulation of devices. However, the FV–CLA echoendoscope has a narrower ultrasound scanning field, and lacks an elevator, which might represent obstacles for clinical use. The aim of this study was to compare the FV–CLA echoendoscope to the OV–CLA echoendoscope for EUS imaging of abdominal organs, and to assess the feasibility of EUS‐guided interventions using the FV–CLA echoendoscope. Methods: EUS examinations were first performed and recorded using the OV–CLA echoendoscope, followed immediately by the FV–CLA echoendoscope. Video recordings were then assessed by two independent endosonographers in a blinded fashion. The EUS visualization and image quality of specific abdominal organs/structures were scored. Any indicated fine‐needle aspiration (FNA) or intervention was performed using the FV–CLA echoendoscope, with the OV–CLA echoendoscope as salvage upon failure. Results: A total of 21 patients were examined in the study. Both echoendoscopes had similar visualization and image quality for all organs/structures, except the common hepatic duct (CHD), which was seen significantly better with the FV–CLA echoendoscope. EUS interventions were conducted in eight patients, including FNA of pancreatic mass (3), pancreatic cyst (3), and cystgastrostomy (2). The FV–CLA echoendoscope was successful in seven patients. One failed FNA of the pancreatic head cyst was salvaged using the OV–CLA echoendoscope. Conclusions: There were no differences between the FV–CLA echoendoscope and the OV–CLA echoendoscope in visualization or image quality on upper EUS, except for the superior image quality of CHD using the FV–CLA echoendoscope. Therefore, the disadvantages of the FV–CLA echoendoscope appear minimal in light of the potential advantages.