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.     

The usefulness of endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of pancreatic neuroendocrine tumors based on the World Health Organization classification

Abstract

Background. We assessed the controversial topic of using 22-gauge needles in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for the diagnosis and evaluation of Ki67 labeling indices (Ki67LI) of pancreatic neuroendocrine tumors (pNET). Methods. Thirty-eight patients with pNET who underwent EUS-FNA between January 1, 2008 and December 31, 2012 were enrolled in this study. When available, the Ki67LI and WHO classifications obtained by EUS-FNA and surgical resection were compared. Results. EUS-FNA with a 22-gauge needle acquired sufficient histological sample to correctly diagnose pNET in 35 cases (92.1%). Both EUS-FNA and surgical histological specimens were available for 19 cases, and grading classes of the 2 procedures were consistent in 17 cases (89.5%) according to the WHO classification based on the Ki67LI. Tumor size was associated with a difference in the Ki67LI between the 2 procedures, although the Ki67LI was almost completely consistent for tumors less than 18 mm in size. Conclusions. EUS-FNA with a 22-gauge needle is a safe and highly accurate technique for the diagnosis of pNET. There was a clear correlation between the Ki67LI of histological specimens acquired by EUS-FNA and surgery. EUS-FNA with a 22-gauge needle is useful to predict the WHO classification of pNET.     

Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses

Background and Study Aims:  The aim of this prospective study was to compare fine-needle aspiration guided by endoscopic ultrasonography (EUS-FNA) using 25-gauge and 22-gauge needles with the EUS-guided 19-gauge Trucut needle biopsy (EUS-TNB) in patients with solid pancreatic mass.
Patients and Methods:  Twenty-four consecutive patients with pancreatic mass underwent biopsies by both EUS-FNA and EUS-TNB. Three needles were compared with respect to technical success rate, tissue size obtained, overall diagnostic accuracy and accuracy for histological and cytological diagnosis.
Results:  The 25-gauge EUS-FNA was technically easier and obtained superior overall diagnostic accuracy than the 22-gauge and Trucut needles, especially in lesions of the pancreas head and uncinate process. Overall accuracy for the 25-gauge, 22-gauge and Trucut needle was 91.7%, 79.7% and 54.1%, respectively. Accuracy for cytological diagnosis irrespective the site of lesions with 25-gauge, 22-gauge and Trucut needles was 91.7%, 75.0%, and 45.8%, respectively. For uncinate masses, it was 100%, 33.3%, and 0.0%, respectively. These differences were significant. Among technically successful patients, the accuracy for histological diagnosis using the 25-gauge was significantly inferior ( P  < 0.05) to 22-gauge and Trucut needles and the rates were 45.8%, 78.9% and 83.3%.
Conclusions:  The 25-gauge FNA needle was significantly superior in terms of technical success rate and overall diagnostic accuracy, especially for the head and uncinate lesions, compared to the 22-gauge and Trucut needles and could be considered 'the best choice needle for cytological diagnosis' of solid pancreatic lesions. If histological diagnosis is required, the 22-gauge FNA needle and Trucut needle may be advantageous for use in head/uncinate and body/tail lesions, respectively.     

Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling

Abstract

Objective. Endoscopic ultrasonography (EUS)-guided fine-needle aspiration (EUS-FNA) may facilitate tissue sampling for histopathological diagnosis of subepithelial tumors (SETs) in the gastrointestinal (GI) tract. However, immunohistochemistry is not always feasible using EUS-FNA samples due to the low quality of specimens often obtained by aspiration. This study aimed to compare the use of 22-gauge (G) EUS-guided fine-needle biopsy (EUS-FNB) with 22G EUS-FNA for core sampling used for histopathological examination, including immunohistochemistry, in patients with GI SETs. Methods. Twenty-eight patients with GI SETs ≥2 cm in size were prospectively enrolled at five university hospitals in Korea between January and June 2013. They were randomized to undergo either EUS-FNB or EUS-FNA. Results. A total of 22 patients was finally analyzed in this study: 10 and 12 patients underwent EUS-FNA and EUS-FNB, respectively. Compared to the EUS-FNA group, the EUS-FNB group had a significantly lower median number of needle passes to obtain macroscopically optimal core samples (4 vs. 2, p = 0.025); higher yield rates of macroscopically and histologically optimal core samples with three needle passes (30% vs. 92%, p = 0.006; 20% vs. 75%, p = 0.010, respectively); and a higher diagnostic sufficiency rate (20% vs. 75%, p = 0.010). No technical difficulties were encountered in either group. Conclusions. This study shows that EUS-FNB has a better ability to obtain histological core samples and a higher diagnostic sufficiency rate than EUS-FNA and that EUS-FNB is a feasible, safe, and preferable modality for adequate core sampling for histopathological diagnosis of GI SETs.     

EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions – a prospective,comparative study

Objectives: Different diagnostic entities can present as solid pancreatic lesions (SPL). This study aimed to explore the utility of endoscopic ultrasound-guided reverse bevel fine-needle biopsy sampling (EUS-FNB) in SPLs.

Material and methods: In 2012–2015, consecutive patients with SPLs were prospectively included in a tertiary center setting and subjected to dual needle sampling with a 22 gauge reverse bevel biopsy needle and a conventional 25 gauge open tip aspiration needle (EUS-FNA). The outcome measures were the diagnostic accuracy of sampling, calculated for each modality separately and for the modalities combined (EUS-FNA?+?FNB), and the adverse event rate related to sampling.

Results: In 68 unique study subjects, the most common diagnostic entities were pancreatic neuroendocrine tumor, PNET, (34%), pancreatic ductal adenocarcinoma, PDAC, (32%), pancreatitis (15%) and metastasis (6%). The overall diagnostic accuracy of EUS-FNB was not significantly different from that of EUS-FNA, (69% vs. 78%, p?=?.31). EUS-FNA?+?FNB, compared with EUS-FNA alone, had a higher sensitivity for tumors other than PDAC (89% vs. 69%, p?=?.02) but not for PDACs (95% vs. 85%, p?=?.5). No adverse event was recorded after the study dual-needle sampling procedures.

Conclusions: Endoscopic ultrasound-guided tissue acquisition performed with a 22 gauge reverse bevel biopsy needle is safe but not superior to conventional fine-needle aspiration performed with a 25 gauge open tip needle in diagnosing solid pancreatic lesions. However, the performance of both these modalities may facilitate the diagnostic work-up in selected patients, such as cases suspicious for pancreatic neuroendocrine tumors and metastases. NCT02360839.     

Slow Pull Versus Suction in Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Solid Masses

Background

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses is an established procedure for obtaining a pathological specimen. However, application of suction during EUS-FNA is still controversial and the efficacy of the slow-pull technique was recently reported for new core biopsy needles.

Aim

The purpose of this study was to compare the suction and slow-pull techniques using regular FNA needles.

Methods

The diagnostic yield of the suction and slow-pull techniques was retrospectively studied for patients who underwent EUS-FNA for pancreatic solid lesions.

Results

A total of 367 passes (181 by suction and 186 by the slow-pull technique) were performed during 97 EUS-FNA procedures for 93 patients with pancreatic solid lesions. The slow-pull technique resulted in lower scores for cellularity (≥2 for 37.5 % vs. 76.7 %) but scores for contamination with blood were lower (≥2 for 25.0 % vs. 66.7 %) and sensitivity of diagnosis of malignancy was higher (90.0 % vs. 67.9 %) when a 25-gauge FNA needle was used. There were no significant differences between the two techniques when a 22-gauge needle was used. In multivariate analysis of 82 cases with malignancy, the slow-pull technique (odds ratio (OR) 1.92, P = 0.028), tumor size ≥25 mm (OR 4.64, P < 0.001), and tumor location in the body or tail (OR 2.82, P < 0.001) were associated with greater sensitivity.

Conclusion

The slow-pull technique was associated with less contamination with blood and can potentially increase the diagnostic yield compared with the suction technique in EUS-FNA of pancreatic solid masses, especially with a 25-gauge FNA needle.     

Endoscopic ultrasonography-guided fine needle aspiration biopsy using 22-gauge needle in diagnosis of autoimmune pancreatitis

Backgrounds

The effectiveness of endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) has not been fully evaluated in the diagnosis of autoimmune pancreatitis (AIP).

Aim

To evaluate the effectiveness of EUS-FNA using 22-gauge needles in the diagnosis of AIP.

Methods

EUS-FNA was examined in 85 patients with pancreatic mass, including 64 patients with pancreatic cancer and 21 patients with AIP. We investigated ability of EUS-FNA using 22-gauge needle for the differential diagnosis between AIP and pancreatic cancer. We also compared the factors concerning FNA procedures (number of needle passes, size of lesion, device, and amount of obtained pancreatic tissue) between two diseases.

Results

Tissues obtained from 21 patients with AIP, although none of them demonstrated histology suspicious for malignancy, did not show histological evidence definitive for AIP. The amount of obtained pancreatic tissue was almost equal between two diseases in each pancreatic location. Sensitivity, specificity, overall accuracy, and negative predictive value of histological diagnosis of pancreatic cancer were 92.2%, 100%, 94.1%, and 80.8%, respectively.

Conclusion

EUS-FNA using 22-gauge needle distinguished benign from malignant pancreatic mass with >90% of accuracy, regardless of the location. Hence, it was helpful for the clinical diagnosis of AIP, however not providing satisfactory samples for the histological diagnosis of AIP.     

Benefit of high negative pressure during endoscopic ultrasound-guided fine-needle aspiration with standard 22-gauge needles for pancreatic lesions: a retrospective comparative study

Objectives: Few studies are available on high negative pressure (HNP) during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). This study compared the diagnostic yield between HNP and normal negative pressure (NNP) during EUS-FNA for solid pancreatic masses.

Methods: Consecutive patients with pancreatic masses who underwent EUS-FNA using a 22-G needle with either HNP or NNP for both the first and second passes were retrospectively examined for diagnostic yield. Rapid on-site evaluation (ROSE) was unavailable at our center. The main outcome measures were the number of passes, diagnostic accuracy and quantity of histological samples.

Results: Two hundred patients underwent EUS-FNA (n?=?97, HNP; n?=?103, NNP) over a 22-month period. A significantly lower median number of passes was required for HNP than for NNP (2 vs. 3; p?<?.001). There was no significant difference in diagnostic accuracy between the two groups. The rate of obtaining a histological sample larger than a 10× power field in length was significantly higher for HNP than for NNP (76.4% vs. 59.6%; p?=?.0019). In the multivariate analysis, a large tumor size (>20?mm) and HNP were identified as factors influencing the acquisition of a larger histological sample.

Conclusions: There was no significant difference in diagnostic accuracy between HNP and NNP. HNP required fewer passes without ROSE and was related to the acquisition of a larger histological sample. HNP may be useful when few samples are available for EUS-FNA with NNP or a larger histological sample is needed.     

The role of EUS-guided fine needle aspiration in autoimmune pancreatitis: a single center prospective study

Abstract

Objectives: Histopathological examination is pivotal in diagnosing autoimmune pancreatitis (AIP). The usefulness of EUS-guided fine needle aspiration (EUS-FNA) in diagnosing AIP remains controversial worldwide. The authors conducted this study to evaluate the efficacy of EUS-FNA for AIP diagnosis using a 22-gauge needle.

Methods: Between January 2013 and May 2017, 37 patients had imaging studies suggestive of AIP at Tongji Hospital, and 27 patients of them were enrolled in this study. Tissue specimens acquired through EUS-FNA were analyzed for periductal lymphoplasmacytic infiltrate (LPI), storiform fibrosis (SF), obliterative phlebitis (OP) and immunoglobulin G4 (IgG4)-positive plasma cell counts. Clinical Trials.gov no: TJ-C20121220.

Results: LPI and SF were present in 18 (66.67%) and 18 (66.67%) of 27 patients, respectively. Abundant IgG4-positive plasmacyte infiltration >10/high-power field (HPF) was detected in 8 of 27 patients (29.63%). OP and the characteristic findings of idiopathic duct-centric chronic pancreatitis (IDCP) and granulocytic epithelial lesion (GEL) were not detected in this study. According to the International Consensus Diagnostic Criteria (ICDC) for AIP, 5 and 12 of 27 patients were assessed as having level 1 and level 2 histological findings, respectively, suggesting that 17 of 27 patients (62.96%) had lymphoplasmacytic sclerosing pancreatitis (LPSP) based on the ICDC.

Conclusions: In 92.6% of patients, pancreatic tissues with >5 HPFs were obtained by EUS-FNA using a 22-G needle. In 63% of patients, histology was evaluated to be?≥?level 2 according to the ICDC. The study indicates that EUS-FNA with a 22-G needle is valuable in the histopathological diagnosis of AIP.     

Multicenter randomized controlled trial comparing the performance of 22 gauge versus 25 gauge EUS–FNA needles in solid masses

Abstract

Background and aims. Few randomized studies have assessed the clinical performance of 25-gauge (25G) needles compared with 22-gauge (22G) needles during endoscopic ultrasound-guided fine needle aspiration (EUS–FNA) biopsy of intra-abdominal lesions. We aimed to compare the diagnostic yield, as well as performance characteristics of 22G versus 25G EUS biopsy needles by determining their diagnostic capabilities, the number of needle passes as well as cellularity of aspirated tissue specimen. Methods. The study is a prospective, randomized, multicenter study. Patients were referred between January 2009 and January 2010 for diagnostic EUS including EUS-guided FNA of different lesions adjacent to the upper GI tract. All patients were randomized to EUS–FNA performed with either a 22G or 25G aspiration needle. Results. EUS–FNA was performed in 135 patients (62 patients with a 22G needle). Sensitivity and specificity of the 22G needle was 94.1% and 95.8%, respectively, and for the 25G needle 94.1% and 100%, respectively. Investigators reported better visualization and performance for the 22G needle compared to the 25G (p < 0.0001). The number of tissue slides obtained was higher for the 22G needle during the second and third needle passes (p < 0.05). We did not observe significant differences between the number and preservation status of obtained cells (p > 0.05). Conclusions. A significant difference was found between the two types of needles in terms of reduced visualization of the 25G needle and suboptimal performance rating. However, this did not impact on overall results since both needles were equally successful in terms of a high diagnostic yield and overall accuracy.     

Endoscopic ultrasound (EUS)-guided Trucut biopsy adds significant information to EUS-guided fine-needle aspiration in selected patients: A prospective study

Objective. Endoscopic ultrasound (EUS)-guided Trucut biopsy (EUS-TCB) has recently emerged as a method that seeks to overcome the limitations of EUS-guided fine needle aspiration (EUS-FNA) by providing a core-tissue specimen needed to increase the yield and accuracy of the diagnosis. The aim of our study was to evaluate whether EUS-TCB adds any information to EUS-FNA in selected patients and to assess the diagnostic yield, overall accuracy and complications of EUS-TCB as compared with EUS-FNA. Material and methods. The study prospectively included 30 patients who had undergone both procedures. Results. The yield of adequate tissue harvesting was similar for EUS-FNA and EUS-TCB (96.4% versus 89.3%, p=NS), with the same number of passes done. The diagnostic accuracy of EUS-FNA was also similar to that of EUS-TCB for the diagnosis of malignant mediastinal masses (73.7% versus 68.4%, p=NS). However, the accuracy for obtaining a specific diagnosis was significantly lower for EUS-FNA compared with EUS-TCB (5.3% and 68.4%, p<0.005). EUS-TCB did not appear to help as a rescue procedure in mediastinal tumours, after a false negative result of EUS-FNA. All cases of submucosal tumours were correctly classified by EUS-TCB as gastrointestinal stromal cell tumours (GISTs) or leiomyomas, while EUS-FNA raised only a suspicion of mesenchymal tumour. Conclusions. EUS-TCB was certainly useful when immunohistochemistry was needed, for example in submucosal tumours and lymphoma, as well as to confirm and characterize the primary or metastatic origin of mediastinal masses. The information provided by EUS-FNA and EUS-TCB is complementary, especially in selected cases where a complete histological diagnosis has an important impact on the clinical management.     

A comparison of the antegrade core trap and reverse bevel needles for EUS-guided fine-needle biopsy sampling of liver mass: a prospective randomized cross over study

BackgroundData on the use of EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) for pathology is limited.MethodsTo prove superiority of the diagnostic rate of the newly designed modified Menghini-type needle with a beveled side-slot near the needle tip with slot cutting edge directed 20-gauge antegrade bevel (group A) over the original 22-gauge reverse bevel (group B) for EUS-guided fine-needle biopsy (EUS-FNB) of solid liver mass (SLM) in a prospective crossover randomized controlled trial.ResultsThe overall diagnostic accuracy rate of the 52 passes was 86.5% (45/52) and of group A versus B were 88.5% (23/26) versus 84.6% (22/26), respectively, p = 0.858. Tissue adequacy levels of both groups were not significantly different (grade A: B: C = 18:6:2 versus 16:7:3), p = 0.839). Grading of blood contamination of both groups was not significantly different. However, it was found that the group-A needles could biopsy tissue of significantly longer length than that of the group B; 1.3 cm (SD = 0.76) versus 0.8 cm (SD = 0.54); p = 0.007.ConclusionThe use of EUS-FNB of SLM is highly effective with similar levels of efficacy and number of adverse events between both types of needles.The trial registration numberThai Clinical Trial Registration No. TCTR2018081002.     

Comparison of 20-gauge Procore® and 22-gauge Acquire® needles for EUS-FNB of solid pancreatic masses: an observational study

Background and Aims: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been proposed to obtain high-quality tissue samples for pancreatic tumors. We performed an observational study to compare EUS-FNB with a 20-gauge Procore® needle versus a 22-gauge Acquire® needle. Our primary endpoint was the quantity of the obtained tissue, as defined by the mean cumulative length of tissue core biopsies per needle pass.

Methods: Sixty-eight EUS-FNB were consecutively performed on patients with a pancreatic mass. The choice of needle depended on availability at the time of admission: 34 punctures were performed with each needle. Histological material was studied in a blinded manner with respect to the needle, and the cumulative length of tissue core biopsies per needle pass was determined. Intraobserver and interobserver variability of this criterion was then evaluated.

Results: There were no between-group differences. Histological diagnosis was achieved and core biopsy specimens were obtained in 28 out of 34 patients (82%) in the 20-gauge Procore® group and in 33 out of 34 patients (97%) in the 22-gauge Acquire® group (p?=?.1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22-gauge Acquire® needle with 8.2?±?4.2?mm versus 4.2?±?3.8?mm for the 20-gauge Procore® needle (p?<?.01). No intra and inter-observer variability of this criterion was observed.

Conclusions: Our results suggest significant differences, with a mean cumulative length of tissue core biopsies per needle pass significantly higher with the 22-gauge Acquire® needle. This simple criterion seems reliable and reproducible.     

EUS-guided 22-gauge fine needle biopsy for the diagnosis of gastric subepithelial tumors larger than 2 cm

Objective. EUS-guided fine needle biopsy (EUS-FNB) was introduced to obtain tissue cores. However, data on the efficacy of EUS-FNB for the diagnosis of gastric subepithelial tumors (SET) are limited. This study was aimed to determine the tissue acquisition and diagnostic yield of EUS-FNB using a novel 22-gauge FNB needle. Material and methods. Between May 2012 and February 2014, we retrieved data on 78 consecutive patients who underwent 22-gauge EUS-FNB for tissue sampling of gastric SET larger than 2 cm. Relevant tumor and EUS-related parameters were reviewed retrospectively. Results. The median tumor diameter was 2.8 cm and tumors were punctured successfully in 77 SET (98.7%). EUS-FNB was diagnostic in 81.8% of SET (63/77), by obtaining core biopsy tissue in 96.8% (61/63) and aspirates in 27.0% (17/63). FNB specimens permitted immunostaining for the diagnosis of gastrointestinal stromal tumors (GIST) in 30 SET (47.6%), 20 leiomyomas (31.7%), and 3 schwannomas (4.8%). Diagnoses could be made without immunostaining in 10 SET (15.9%). Tissue adequacy was optimal in 85.7% of FNB specimens by endosonographers’ on-site visual evaluation. Endosonographers’ evaluation of tissue adequacy was the only factor significantly associated with a higher diagnostic yield in univariate analysis. No adequate high-power fields for GIST risk stratification were available in FNB specimens. There was a single case of post-procedural bleeding (1.3%). Conclusion. EUS-FNB using 22-gauge needle obtains a high yield for the diagnosis of gastric SET ≥2 cm, mostly via core tissue acquisition. Endosonographers should pay careful attention to the adequacy of FNB specimens.     

Clinical validity of 25-gauge endobronchial ultrasound-guided transbronchial needle in lymph node staging of lung cancer

BackgroundEndobronchial ultrasound-guided transbronchial needle aspiration is recommended for lymph node (LN) staging in lung cancer. Although 22-gauge needles are widely used, they may make some stations difficult to puncture owing to an acute angle. A thinner 25-gauge needle was introduced in Japan at the end of 2016 and offered structural advantages such as improved flexibility and penetrability. We aimed to validate the clinical utility of the 25-gauge needle in LN staging.MethodsPatients who underwent endobronchial ultrasound-guided transbronchial needle aspiration for LN staging of lung cancer using the 25-gauge needle at our institution between November 2016 and March 2019 were included. Patient characteristics, staging procedures, pathology findings, and genetic testing success rates were assessed.ResultsData of 130 patients were included in the analysis. The sampling rate was 87.6% (589/672 lesions). In addition to stations #4R, #7, and #11, which are generally easy to puncture, multiple stations (40.1%) were sampled. The diagnostic accuracy of combined computed tomography and fluorodeoxyglucose positron emission tomography was 82.3% and that of additional endobronchial ultrasound-guided transbronchial needle aspiration was 96.9%. The overall sensitivity, specificity, and positive and negative predictive values validated using resected specimens were 97.1% (34/35), 100% (41/41), 100% (34/34), and 97.6% (41/42), respectively. The success rate of genetic testing was 100% (34/34).ConclusionsThe new 25-gauge needle enabled us to approach a wide range of LNs with a desirable sampling rate and diagnostic accuracy in LN staging using endobronchial ultrasound-guided transbronchial needle aspiration, while providing enough tissue for genetic testing.     

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.     

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.     

Diagnostic yield of EUS-FNA of small(≤15 mm) solid pancreatic lesions using a 25-gauge needle

Background: Early detection of small solid pancreatic lesions is increasingly common. To date, few and contradictory data have been published about the relationship between lesion size and endoscopic ultrasound-guided fine needle aspiration(EUS-FNA) diagnostic yield. The aim of this study was to assess the relation between the size of solid pancreatic lesions and the diagnostic yield of EUS-FNA using a 25-gauge needle in a center without available rapid on-site evaluation.Methods: In the retrospective cohort study, we selected patients who underwent EUS-FNA for solid pancreatic lesions with a 25-gauge needle from October 2014 to October 2015. Patients were divided into three groups(≤15 mm, 16–25 mm and 25 mm), and the outcomes were compared.Results: We analyzed 163 patients. Overall adequacy, sensitivity, specificity and accuracy were 85.2%,81.8%, 93.7%, and 80.4%, respectively. When stratified by size, the sensitivity and accuracy correlated with size(P = 0.016 and P = 0.042, respectively). Multivariate analysis showed that lesion size was the only independent factor(P = 0.019, OR = 4.76) affecting accuracy. The role of size as an independent factor affecting accuracy was confirmed in a separate multivariate analysis, where size was included in the model as a covariate(P = 0.018, OR = 1.08).Conclusion: Our study demonstrates that, in the absence of rapid on-site evaluation, mass size affects the accuracy of EUS-FNA of solid pancreatic lesions.     

Elevated serum CA 19-9 in hepatic actinomycosis

Abstract

Objective. It is controversial whether endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is beneficial in all patients with suspected pancreatic cancer. The aim of this study was to assess diagnostic yield, safety and impact of EUS-FNA on management of patients with solid pancreatic mass. Material and methods. Consecutive patients undergoing EUS-FNA of solid pancreatic mass were enrolled. Gold standard for final diagnosis included histology from surgical resection. In patients without surgery, clinical evaluation methods and repeated imaging studies were used for the comparison of initial cytology and final diagnosis. Patients were followed-up prospectively focusing on subsequent treatment. Results. Among 207 enrolled patients, final diagnosis was malignant in 163 (78.6%) and benign in 44 (21.4%). The sensitivity, specificity and accuracy of EUS-FNA in diagnosing pancreatic cancer were 92.6% (95% CI: 87.20–95.96), 88.6% (95% CI: 74.64–95.64) and 91.8% (95% CI: 87.24–94.81), respectively. No major and five (2.4%) minor complications occurred. Of 151 true-positive patients by EUS-FNA, 57 (37.7%) were surgically explored, of whom 28 (49.1%) underwent resection. Ten of 12 patients with false-negative cytology were explored based on detection of mass on EUS, of whom two had a delay due to false-negative cytology without curative treatment. From the whole study cohort, EUS-FNA had positive and negative impacts on subsequent management in 136 (65.7%) and 2 (0.9%) patients, respectively. Conclusions. EUS-FNA provides accurate diagnosis in 92% and has positive therapeutic impact in two-thirds of patients with solid pancreatic mass. Despite negative cytology, surgical exploration is recommended in clinical suspicion for pancreatic cancer and solid mass on EUS.     

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.