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.     

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.     

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 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.     

Comparison between EUS-guided fine-needle aspiration cytology and EUS-guided fine-needle biopsy histology for the evaluation of pancreatic neuroendocrine tumors

Background/objectivesStudies comparing EUS-guided fine-needle aspiration (EUS-FNA) with EUS-guided fine-needle biopsy (EUS-FNB) for the evaluation of pancreatic neuroendocrine tumors (pNETs) are lacking. We aimed at comparing EUS-FNA with EUS-FNB in terms of Ki-67 proliferative index (PI) estimation capability, cellularity of the samples, and reliability of Ki-67 PI/tumor grading compared with surgical specimens.MethodsPatients diagnosed with pNETs on EUS and/or surgical specimens were retrospectively identified. Specimens were re-evaluated to assess Ki-67 PI feasibility, sample cellularity by manual counting, and determination of Ki-67 PI value. Outcomes in the EUS-FNA and EUS-FNB groups were compared. Kendall rank test was used for Ki-67 PI correlation between EUS and surgical specimens. Subgroup analysis including small (≤20 mm), non-functioning pNETs was performed.ResultsThree-hundred samples from 292 lesions were evaluated: 69 EUS-FNA cytology and 231 EUS-FNB histology. Ki-67 PI feasibility was similar for EUS-FNA and EUS-FNB (91.3% vs. 95.7%, p = 0.15), while EUS-FNB performed significantly better in the subgroup of 179 small pNETs (88.2% vs. 96.1%, p = 0.04). Rate of poor cellulated (<500 cells) specimens was equal between EUS-FNA and EUS-FNB. A significant correlation for Ki-67 PI values between EUS and 92 correspondent surgical specimens was found in both groups, but it was stronger with EUS-FNB (tau = 0.626, p < 0.0001 vs. tau = 0.452, p = 0.031). Correct grading estimation was comparable between the two groups (p = 0.482).ConclusionOur study showed stronger correlation for Ki-67 values between EUS-FNB and surgical specimens, and that EUS-FNB outperformed EUS-FNA in the evaluation of small pNETs. EUS-FNB should become standard of care for grading assessment of suspected pNETs.     

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.     

Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy

Background and aimAdequate tissue acquisition is important in making treatment decisions for patients with upper gastrointestinal subepithelial tumors (SETs). This study aimed to compare the outcomes of endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) with those of the unroofing biopsy technique.MethodsThis study was a single-center, prospective comparative study conducted at Severance Hospital, Yonsei University College of Medicine. A total of 39 patients with SETs ≥15 mm were enrolled between January 2016 and August 2017.ResultsOf the 39 patients, 28 underwent biopsy with both techniques (4 underwent only unroofing and 7 underwent only EUS-FNB). Histological diagnosis was made with EUS-FNB in 64.3% and unroofing biopsy in 78.6% (p = 0.344), and immunohistochemical diagnosis was made with EUS-FNB in 46.4% and unroofing biopsy in 67.9% (p = 0.180). In the subgroup analysis (28 patients), there was no significant difference in diagnostic yield between the 2 methods The mean procedural time with EUS-FNB was shorter than that with unroofing biopsy (p < 0.001). The larger SET (≥ 20 mm) (p = 0.035) and satisfaction of procedure (p = 0.019) were positively associated with successful histological diagnosis by EUS-FNB.ConclusionsThere was no significant difference in the histological diagnostic yield for SETs between the EUS-FNB and unroofing biopsy techniques (CinicalTrials.gov. identifier NCT02646241).     

Diagnostic ability of EUS-FNA for pancreatic solid lesions with conventional 22-gauge needle using the slow pull technique: a prospective study

Abstract

Objective. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) using the slow pull technique (SP-FNA) has recently attracted attention as an effective tissue acquisition technique. However, efficacy of SP-FNA with a 22-gauge conventional needle remains unclear. The aim of this study is to evaluate the diagnostic ability of SP-FNA with a 22-gauge needle. Material and methods. Patients with a pancreatic solid lesion were prospectively enrolled in this study. SP-FNA was performed at two needle passes with a 22-gauge needle. One dedicated pathologist evaluated the obtained samples in terms of quantity (Grade 0: scant; Grade 1: inadequate; Grade 2: adequate), quality (Grade 0: poor; Grade 1: moderate; Grade 2: good), and blood contamination (Grade 0: significant; Grade 1: moderate; Grade 2: low), and provided a pathological diagnosis. Additional EUS-FNA was performed by applying suction (SA-FNA). The evaluation points were as follows: diagnostic accuracy of SP-FNA compared with that of SA-FNA, and the quantity, quality, and blood contamination level of SP-FNA-obtained samples. Results. We enrolled 40 cases. The diagnostic accuracy of SP-FNA was 90% (36/40). There was no significant difference in the accuracy between SP-FNA and SA-FNA (90% vs. 90%, p = 1.000). The samples obtained using SP-FNA were assessed as Grade 2 for quantity in 29 cases (73%), quality in 31 (78%), and blood contamination in 25 (63%). Conclusions. Adequate, high-quality, and unsubstantially blood-contaminated samples could be obtained using SP-FNA. The diagnostic ability of SP-FNA was 90%, which appeared to be similar to that of SA-FNA.     

22-gauge core vs 22-gauge aspiration needle for endoscopic ultrasound-guided sampling of abdominal masses

AIM To compare the aspiration needle(AN) and core biopsy needle(PC) in endoscopic ultrasound-guided fine needle aspiration(EUS-FNA) of abdominal masses.METHODS 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 22 G PC(Echo Tip Pro Core; 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.RESULTS 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.CONCLUSION 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.     

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.     

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.     

Randomized controlled trial comparing a conventional needle and a novel needle for endoscopic ultrasound (EUS)-guided histology of peripancreatic masses

Introduction:Cytological study of samples obtained by Endoscopic ultrasound (EUS)-guided fine-needle aspiration (EUS-FNA) allows for recognition of clear signs of malignant transformation. However, certain neoplasms can be difficult to diagnose without histological analysis. Recently, a novel EUS-guided fine needle biopsy (EUS-FNB) needle was developed to increase tissue acquisition. This study set out to investigate the usefulness of this novel EUS-FNB needle (NEFN) in terms of obtaining a proper histology compared with a conventional EUS-FNA needle (CEFN).Methods:This investigation was a prospective, single-blind, randomized study in a single academic hospital. Primary outcome was the acquisition rate of an appropriate and sufficient specimen for histologic assessment. Secondary outcomes were diagnostic yield of peripancreatic masses using a CEFN and a NEFN. Furthermore, we assessed the feasibility of determining K-ras mutation status according to needle type.Results:The study enrolled 56 consecutive patients. Technical success rates were 96.6% (28/29) for the CEFN and 100% (27/27) for the NEFN (P = 1.000). No complications occurred during or after the procedure in either needle group. An adequate sample for cytologic diagnosis was obtained in 89.7% (26/29) of patients in the CEFN group vs 96.3% (26/27) of patients in the NEFN group (P = .612). For histologic diagnosis, a sample with a biopsy adequacy score of 2 or more was obtained in 41.4% (12/29) of CEFN-acquired samples vs 88.9% (24/27) of NEFN-acquired samples (P < .001). K-ras mutation analysis using histologic specimens was possible in 13 (44.8%) CEFN-acquired samples and 25 (92.6%) of NEFN-acquired samples. This difference was significant (P < .001).Conclusions:The present study suggests that the NEFN is an effective and reliable alternative compared to a CEFN in terms of tissue acquisition rate and quality of histologic sampling.     

Histological diagnosis and grading of pancreatic neuroendocrine tumor by endoscopic ultrasound-guided fine needle biopsy using a 25-gauge needle with a core trap: A multicenter prospective trial

ObjectivesPreoperative grading of pancreatic neuroendocrine tumors (PanNET) is challenging. The aim of this study was to prospectively evaluate the use of a 25-gauge needle with a core trap for diagnosis and grading of PanNET.MethodsThis multicenter prospective trial was registered with the University Hospital Medical Information Network (UMIN000021409). Consecutive patients with suspected PanNET between June 2016 and November 2017 were enrolled. All patients underwent endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using a 25-gauge needle with a core trap. Samples obtained after the first needle pass were used for central pathological review. EUS-FNB was evaluated in terms of (i) technical success rate, (ii) adequacy for histological evaluation, (iii) complication rate during the procedure, and (iv) concordance between PanNET grading on EUS-FNB and that after analysis of the resected tumor.ResultsFifty-two patients were enrolled. Of the 36/52 patients who underwent surgical resection, 31 were finally diagnosed with PanNET and were eligible for analysis. The technical success rate of EUS-FNB was 100%. The rate of adequacy for histological evaluation was 90.3%. There were no complications related to EUS-FNB. The concordance rate between PanNET grading on EUS-FNB and that after analysis of the resected tumor was 82.6% (95% confidence interval = 61.22–95.05, P = 0.579).ConclusionsEUS-FNB using a 25-gauge needle with a core trap is feasible, providing histological samples are of sufficient quality for diagnosis and grading of PanNET.     

Suction versus slow-pull for endoscopic ultrasound-guided fine-needle aspiration of pancreatic tumors: a prospective randomized trial

BackgroundSuction (S) is commonly used to improve cell acquisition during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). Slow-pull (SP) sampling is another technique that might procure good quality specimens with less bloodiness. We aimed to determine if SP improves the diagnostic yield of EUS-FNA of pancreatic masses.MethodsPatients with pancreatic solid masses were randomized to four needle passes with both techniques in an alternate fashion. Sensitivity, specificity, positive, and negative predictive values were calculated. Cellularity and bloodiness of cytological samples were assessed and compared according to the technique.ResultsSensitivity, specificity, and accuracy of suction vs. SP were 95.2% vs. 92.3%; 100% vs. 100; 95.7% vs. 93%, respectively. As to the association of methods, they were 95.6, 100 and 96%, respectively. Positive predictive values for S and SP were 100%. There was no difference in diagnostic yield between S and SP (p = 0.344). Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980). Bloodiness of SP and suction techniques were similar as well.ConclusionsS and SP techniques provide equivalent sensitivity, specificity, and accuracy. Association of methods seems to improve diagnostic yield. Suction does not increase the bloodiness of samples compared to slow-pull.     

Comparison between endoscopic ultrasound-guided fine-needle biopsy and bite-on-bite jumbo biopsy for sampling of subepithelial lesions

Background and AimsA direct comparison between endoscopic ultrasound (EUS) fine-needle biopsy (FNB) and current endoscopic biopsy techniques in patients with subepithelial lesions (SELs) is still lacking. Aim of this multicenter study was to compare the diagnostic performance and safety profile between EUS-FNB and bite-on-bite jumbo biopsy.MethodsOut of 416 patients undergoing endoscopic sampling of SELs between 2017 and 2021, after propensity score matching two groups were compared: 120 undergoing EUS-FNB and 120 sampled with bite-on-bite jumbo biopsy. Primary outcome was sample adequacy. Secondary outcomes were diagnostic accuracy, sensitivity, specificity, and adverse events.ResultsMedian age was 61 years and most patients were male in both groups. Final diagnosis was GIST in 65 patients (54.1%) in the EUS-FNB group and 62 patients in the bite-on-bite biopsy group (51.6%; p = 0.37). Sample adequacy was significantly higher in the EUS-FNB group as compared to the bite-on-bite biopsy group (94.1% versus 77.5%, p<0.001). EUS-FNB outperformed bite-on-bite biopsy also in terms of diagnostic accuracy (89.3% versus 67.1%, p<0.001) and sensitivity (89% vs 64.5%; p<0.001), whereas specificity was 100% in both groups (p = 0.89). These findings were confirmed in subgroup analysis according to SEL location, final diagnosis, and wall layers of the sampled SEL. Adverse event rate was 6.6% in the EUS-FNB group and 30% in the bite-on-bite biopsy group (p<0.001).ConclusionEUS-FNB outperforms bite-on-bite biopsy both in terms of diagnostic yield and safety profile.     

Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study

Background: There are very few available data on the novel SharkCore? needles for EUS-FNB.

Aim: Comparison of the performance of the SharkCore? needles with the standard EUS-FNA needles for the diagnosis of solid upper GI masses.

Patients and methods: Single-center, retrospective cohort study in an academic tertiary referral hospital. Patients were matched 1:1 for the site of the lesion and the presence or absence of rapid on-site evaluation (ROSE).

Results: A total of 102 patients were included. There was no statistically significant difference in the mean number of passes (3.3?±?1.3 versus 3.4?±?1.5; p?=?.89). Similar results were observed at the subgroup with ROSE (4.3?±?1.3 versus 3.7?±?1.5; p?=?.26). More histological specimens were obtained with the SharkCore? needles compared to standard needles (59 versus 5%; p?<?.001). Diagnostic test characteristics were not significantly different (sensitivity: 91.5 versus 85.7; specificity: 100 versus 100%; accuracy: 92.2 versus 85.4% for SharkCore? versus standard needles, p?>?.05 in all cases). At multivariable analysis, there was no statistically significant difference in the mean number of passes in all patients (p?=?.23) and in the ROSE subgroup (p?=?.66). However, the SharkCore? needle obtained significantly more histological material than the standard needle (odds ratio 66; 95% confidence interval: 11.8, 375.8, p?<?.001). There was no significant difference in complication rates (p?=?.5).

Limitations: Retrospective study, single-center.

Conclusion: The SharkCore needles were similar to standard FNA needles in terms of the number of passes to reach diagnosis, but obtained significantly more histological specimen.     

Accuracy of visual on-site evaluation (Vose) In predicting the adequacy of Eus-guided fine needle biopsy: A single center prospective study

ObjectiveEndoscopic ultrasound is the standard procedure for the diagnosis of pancreatic lesions and new needles have been developed to improve tissue acquisition (FNB). Rapid onset evaluation (ROSE) decreases the number of needle passes but is not always available. We introduced an easy and rapid method of direct classification of EUS-FNB sample namely Visual on-site evaluation (VOSE).AimsTo assess the accuracy of VOSE in predicting the histological adequacy of specimens. To evaluate the diagnostic power of FNB and the rate of core tissue obtained.MethodsProspective single center study on patients with pancreatic lesions that underwent EUS-FNB. VOSE parameters were presence of blood, macroscopic visible core (MVC), number, color and length of specimen. The association between VOSE tool and histological adequacy was assessed. Fisher’s exact test and Student’s t-test used to compare categorical and continuous variables. Logistic regression analysis was used to assess association between variables.Results99 patients (58.6% male; mean age 68.4 ± 10) enrolled, including 102 lesions. Total number of passes was 358 with median number of 4 (range, 2–4). The 92.7% of samples were adequate and it was higher with the 22-G needle than with 25G (96.5% vs 89.2% p 0.01). VOSE “red-mixed specimen” was associated with a higher probability of histological adequacy (OR 2.39 95% CI 1.03–5.42 p = 0.04).ConclusionsThe VOSE tool “red-mixed specimen” can be used to predict the histological adequacy and guide the number of needle passes. Overall, FNB provides a high rate of adequate and diagnostic specimen and high rate of core tissue especially with the 22G needle.     

Gross visual inspection by endosonographers during endoscopic ultrasound-guided fine needle aspiration

Background/objectives

A clear criterion for terminating endoscopic ultrasound fine needle aspiration (EUS-FNA) without rapid on-site evaluation (ROSE) has not been established. However, a possible solution includes gross visual inspection (GVI) of the sample obtained with EUS-FNA. We performed a retrospective study to elucidate the efficacy of GVI for the diagnostic yield of EUS-FNA.

EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial

BackgroundRapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome.AimsThe primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed.MethodsFROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online.DiscussionThis study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions.     

Endoscopic ultrasound fine needle aspiration vs fine needle biopsy for pancreatic masses,subepithelial lesions,and lymph nodes

Endoscopic ultrasound tissue acquisition, in the form of both fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB), is utilized for pancreatic mass lesions, subepithelial lesions, and lymph node biopsy. Both procedures are safe and yield high diagnostic value. Despite its high diagnostic yield, EUS-FNA has potential limitations associated with cytological aspirations, including inability to determine histologic architecture, and a small quantitative sample for further immunohistochemical staining. EUS-FNB, with its larger core biopsy needle, was designed to overcome these potential limitations. However, it remains unclear which technique should be used and for which lesions. Comparative trials are plagued by heterogeneity at every stage of comparison; including variable needles used, and different definitions of endpoints, which therefore limit generalizability. Thus, we present a review of prospective trials, systematic reviews, and meta-analyses on studies examining EUS-FNA vs EUS-FNB. Prospective comparative trials of EUS-FNA vs EUS-FNB primarily focus on pancreatic mass lesions, and yield conflicting results in terms of demonstrating the superiority of one method. However, consistent among trials is the potential for diagnosis with fewer passes, and a larger quantity of sample achieved for next generation sequencing. With regard to subepithelial lesions and lymph node biopsy, fewer prospective trials exist, and larger prospective studies are necessary. Based on the available literature, we would recommend EUS-FNB for peri-hepatic lymph nodes.