Shantel Hebert-Magee

Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions

BACKGROUND To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS. OBJECTIVE To compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses. DESIGN Randomized trial. SETTING Tertiary-care medical center. PATIENTS This study involved 56 patients with solid pancreatic masses. INTERVENTION Sampling of pancreatic masses by using 22G FNA or 22G FNB devices. MAIN OUTCOME MEASUREMENTS Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen. RESULTS A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively. LIMITATIONS Only pancreatic masses were evaluated. CONCLUSION Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types.

The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis.

A meta‐analysis has not been previously performed to evaluate critically the diagnostic accuracy of endoscopic ultrasound‐guided fine needle aspiration (EUS‐FNA) of solely pancreatic ductal adenocarcinoma and address factors that have an impact on variability of accuracy. The aim of this study was to determine whether the presence of a cytopathologist, variability of the reference standard and other sources of heterogeneity significantly impacts diagnostic accuracy.

Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle

BACKGROUND A needle made of nitinol has been developed with enhanced flexibility to overcome the limitations of the currently available 19-G EUS-FNA needles. OBJECTIVE Evaluate the ability to perform transduodenal FNAs, procure histologic specimens, and undertake therapeutic interventions using the flexible 19-G needle. DESIGN Prospective cohort study. SETTING Tertiary-care academic medical center. PATIENTS Consecutive patients with subepithelial masses, pancreatic head or uncinate lesions, or lesions adjacent to the pancreatic head, and patients undergoing therapeutic intervention. INTERVENTIONS Perform tissue acquisition and interventions with the flexible 19-G FNA needle. MAIN OUTCOME MEASURES Evaluate the ability to perform transduodenal passes with the flexible 19-G FNA needle. Also, assess the utility of the needle to yield both cytologic and histologic samples and to perform therapeutic interventions. RESULTS Of the 50 patients enrolled, tissue acquisition was undertaken in 38 and therapeutic intervention in 12. Of 38 patients from whom tissue was procured, 32 tissue samples were from pancreatic head/uncinate or peripancreatic masses and 6 were from subepithelial masses. Tissue acquisition, which included transduodenal passes, was successful and adequate for cytologic assessment in all 38 patients (100%). Satisfactory histologic specimens were procured from 36 of 38 (94.7%) patients. An onsite diagnosis was established in 35 of 38 (92.1%) patients. In 3 patients with indeterminate/suspicious lesions, a definitive diagnosis was established at histology. A mean of 1.45 ± 0.79 passes per patient was performed. All 12 therapeutic interventions were successful (100%) and included pseudocyst drainage in 5, pelvic abscess drainage in 2, fiducial placement in 2, celiac plexus neurolysis in 2, and cholangiogram in 1. Needle dysfunction or procedural complications were not encountered. LIMITATIONS Single-center study with limited power. CONCLUSIONS Preliminary data suggest that the flexible 19-G needle can be used for procuring cytologic aspirates and histologic specimens and to undertake therapeutic interventions even by the transduodenal route. Confirmatory studies are required in a larger cohort of patients with varied pathologic conditions to validate these findings.

Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment.

Recently, a 22‐gauge (G) needle with a Franseen tip design was developed for endoscopic ultrasonography‐guided fine‐needle biopsy (EUS‐FNB). The present study evaluated the performance of the Franseen biopsy needle in EUS‐guided tissue acquisition.

Randomized Trial Comparing the Flexible 19G and 25G Needles for Endoscopic Ultrasound-Guided Fine Needle Aspiration of Solid Pancreatic Mass Lesions

Objectives Although a large gauge needle can procure more tissue at endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), its advantage over smaller needles is unclear. This study compared flexible 19G and 25G needles for EUS-FNA of solid pancreatic masses. Methods This was a randomized trial of patients undergoing EUS-FNA of pancreatic masses using flexible 19G or 25G needle. Main outcome measure was to compare median number of passes for on-site diagnosis. Secondary measures were to compare specimen bloodiness, complications, technical failures, and histological core tissue procurement. Results One hundred patients were randomized to EUS-FNA using flexible 19G or 25G needle. Median of 1 pass was required to achieve on-site diagnosis of 96% and 92% (P = 0.68) in 19G and 25G cohorts. There was no significant difference in technical failure (0% vs 2%, P = 0.99) or adverse events (2% vs 0%, P = 0.99) between 19G and 25G cohorts. Although histological core tissue procurement was significantly better with flexible 19G needle (88% vs 44%, P < 0.001), specimens were bloodier (severe bloodiness, 36% vs 4%; P < 0.001). Conclusions As there is no significant difference in the performance of flexible 19G and 25G needles, needle choice for sampling pancreatic masses should be based on endoscopist preference and need for histology.

Basic technique for solid lesions: Cytology, core, or both?

This chapter highlights key fundamentals relevant to post-procurement tissue handling of materials obtains by aspiration and/or biopsy and details the subtle techniques that can significantly impact patient management and practice patterns. A basic knowledge of tissue handling and processing is imperative for endosonographers who attempt to achieve a greater than 95% diagnostic accuracy with their tissue-acquisition procedures.

Endoscopic ultrasound-guided tissue acquisition

Endoscopic ultrasound (EUS) is an indispensable tool for tissue acquisition in patients with gastrointestinal tumors. While fine‐needle aspiration (FNA) has been routinely carried out for establishing tissue diagnosis, the emerging concept of tailoring chemotherapeutic agents based on molecular markers has increased the demand for core tissue procurement by means of EUS‐guided fine‐needle biopsy (EUS‐FNB). In addition, FNB may offset the limitations of FNA wherein the diagnostic sensitivity is incumbent on the availability of an onsite cytopathologist. Given the increasing number of procedures being done, developing a unit‐specific algorithmic approach for needle selection isimportant to improve the procedural efficiency and utilization of resources. Finally, the best outcomes can be attained only by practicing evidence‐based techniques, procuring adequate quantity of sample for ancillary studies and processing the specimens appropriately.

Training endosonographers in cytopathology: improving the results of EUS-guided FNA

BACKGROUND Although on-site cytopathology services have a significant impact on efficiency and accuracy of EUS-guided FNA (EUS-FNA), the availability of this service is variable. OBJECTIVE To evaluate the impact of an intensive 2-day training program to educate endosonographers in EUS-related cytopathology. DESIGN Pilot study. SETTING Tertiary care medical center. SUBJECTS Six endosonographers (5 male, median age, 35 years) with minimal previous cytopathology exposure comprised the study cohort. METHODS Pre- and posttraining testing was administered. Training commenced with a cytopathology tutorial focusing on 4 performance measures: specimen adequacy, sample interpretation, specimen processing, and preliminary diagnosis. Eight live EUS-FNA cases were then performed, and study participants independently completed 4 questions based on performance measures for each case. The ability to independently smear and stain slides and operate a microscope was additionally assessed after a hands-on tutorial. MAIN OUTCOME MEASUREMENTS Comparison of pretraining and posttraining scores, improvement in performance measures for live cases, and ability to independently handle specimens and operate a microscope. RESULTS Compared with pretraining, mean posttraining test scores improved by 63% from 48 to 78 out of 100. Mean live case performance score was 95%. Performances improved from 89% on day 1 to 100% on day 2. After training, all endosonographers could independently smear/stain slides and operate a microscope. LIMITATIONS Long-term impact is unclear. CONCLUSIONS An intensive 2-day program was effective in training endosonographers in the basics of EUS-related cytopathology. Incorporating basic cytopathology in EUS fellowship curriculum will likely improve diagnostic performance of tissue acquisition procedures.

Is there a role for endoscopic ultrasound-guided fine-needle biopsy in pancreatic cancer?

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has transformed the practice of diagnosing pancreatic adenocarcinoma by displacing surgical biopsy, and thus has resulted in lower cost, technical ease, and decreased morbidity [1]. However, there is now an increased demand for more precise “tumor-specific” diagnoses, as the treatment paradigm is shifting to a more personalized approach. This, in turn, has led to the need for better tissue fragments for cancer biomarker testing and grading. The two major limiting factors encountered in EUS-FNA are the quality and quantity of the tissue obtained. These limitations have prompted investigation into the use of larger-caliber needles, which have led to the analysis of fine-needle biopsy (FNB) as a workable alternative. Intuitively, the assumption has been made that larger or more specialized needles would yield better tissue for subsequent molecular biological analysis and histologic grading. This issue of Endoscopy contains the report from a study by Larghi et al., which evaluated a standard 19-G or 19-G ProCore needle for performing preoperative EUS-FNB in 42 patients with pancreatic ductal adenocarcinoma (PDAC) [2]. Four experienced pathologists who were blinded to the results of surgical resection performed the histologic grading. The accuracy of preoperative grading of PDAC by EUS-FNB was 56%, with significant heterogeneity and suboptimal agreement among the four pathologists (κ=0.27; 95% confidence interval 0.14–0.38). The results of this study suggest that EUS-FNB does not allow for reliable preoperative grading of PDAC. Moreover, these results align with the results of two other studies that were reported recently in Endoscopy. Lee et al. compared the ProCore needle with the standard FNA needle (n=116) and found no significant difference in overall diagnostic accuracy (FNA 94.8% vs. FNB 98.3%; P=0.67) or histological accuracy (FNA 77.6 % vs. FNB 82.8%; P=0.64) [3]. In a randomized, crossover study by Vanbiervliet et al. (n=80), which used the standard 22-G FNA needle and 22-G ProCore needle, the quality of the tissue was statistically better with the standard needle as evaluated by two pathologists (expert 1, P=0.009; expert 2, P=0.002) [4]. The issue is not that FNB does not obtain histologic tissue, but rather it does not consistently obtain optimal (diagnostic and sufficient) tissue. This is supported by a recent study by Iwashita et al., which evaluated the macroscopic appearance of 111 biopsy specimens procured using the 19-G needle. Although a macroscopically visible core tissue was obtained in 91%, histologic core tissue was seen in only 79%, with a particularly high false-negative rate in pancreatic lesions [5]. Unlike surgical resection specimens, which embody the entire tumor, EUS-guided biopsies sample only a focal area of the suspected lesion. Histologic examination of such biopsies increases the probability of sampling and interpretation errors secondary to tumor heterogeneity. This is corroborated by two studies evaluating pancreatic neuroendocrine grading on EUS-FNA using the Ki-67 index. Both studies found high reproducibility and interobserver agreement when sufficient tissue was present, and significant discordance between the histologic and cytologic findings when limited EUS-guided material was evaluated [6,7]. Advances in EUS tissue acquisition have been an iterative process, where continual re-evaluation of the best tools and techniques has indisputably led to its success. Therefore, in an effort to rectify our shortcomings, we must start by asking, “Is there truly a role for EUS-FNB in pancreatic malignancy?” and “What can we do to make EUS-FNB successful?” Pancreatic ductal adenocarcinoma is extremely aggressive and carries a poor prognosis. There are limited therapeutic options, such as gemcitabine and paclitaxel, or leucovorin and fluoroura-

Frequency of occurrence and characteristics of primary pancreatic lymphoma during endoscopic ultrasound guided fine needle aspiration: A retrospective study

BACKGROUND Primary pancreatic lymphoma is a rare tumour of the pancreas. Data on the role of endoscopic ultrasound guided fine needle aspiration for its diagnosis are scant. AIM To identify the frequency of occurrence, sonographic characteristics and cytological findings that are predictive of primary pancreatic lymphoma. METHODS Pancreatic lymphoma cases were identified by retrospective review of solid pancreatic masses over 10-year period. RESULTS 12/2397 (0.5%) lesions were identified. Patients were predominantly white (92%) and male (58%). Mean largest dimension was 47.5mm and 83.3% were located in the head. The mass appeared heterogeneous in 75% and peripancreatic lymphadenopathy was noted in 58%. None of the patients showed features of chronic pancreatitis or pancreatic ductal dilation. Rapid onsite analysis revealed atypical lymphocytes in 92%. Flow cytometry confirmed diagnosis in 75% of cases. CONCLUSIONS Primary pancreatic lymphoma is encountered in 0.5% of patients undergoing endoscopic ultrasound guided fine needle aspiration. A large heterogeneous mass, in the absence of chronic pancreatitis or pancreatic duct dilation that reveals atypical lymphocytes on fine needle aspiration is suggestive.