The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial.

OBJECTIVES: Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS-FNA of pancreatic masses with and without OCE. METHODS: In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS-FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE- arm. EUS-FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis. RESULTS: A total of 241 patients (121 OCE+, 120 OCE-) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE- 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS-FNA passes (median, OCE+ 4 vs. OCE- 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination. CONCLUSIONS: Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS-FNA with or without OCE.

Compliance with surveillance recommendations for foregut subepithelial tumors is poor: results of a prospective multicenter study.

BACKGROUND: American Gastroenterological Association guidelines recommend performing EUS to characterize subepithelial lesions (SELs) discovered on upper endoscopy (EGD), followed by surveillance if no high-risk features are identified. However, limited data are available on the impact of and compliance with surveillance recommendations. OBJECTIVE: To determine the natural history of SELs<30 mm in size evaluated by EUS and to determine the degree of patient compliance with surveillance recommendations. DESIGN: Prospective registry. SETTING: Two tertiary centers. PATIENTS: We studied 187 consecutive adult patients referred for EUS evaluation of foregut SELs. MAIN OUTCOME MEASUREMENTS: Proportion of patients in whom SELs change in size or echo-features and compliance with follow-up recommendations. RESULTS: Surveillance was recommended in 65 patients with hypoechoic SELs (44.6% women, age 59.5±13.2 years); of these, 29 (44.6%) underwent surveillance EUS as recommended and were followed for a median of 30 months (range, 12-105). During follow-up, 16 SELs (25%) increased in size, with a mean increase of 3.4±3.9 mm (range, 1-15). No changes in echo-texture of the SELs were observed. One patient was referred to surgery during follow-up (because of SEL growth>30 mm). LIMITATIONS: Short follow-up duration; compliance was a secondary aim. CONCLUSIONS: During a median follow-up of 30 months, growth in size was observed in 25% of small foregut SELs. However, change in size was minimal, and only 1 patient was referred for surgery based on surveillance EUS findings. Compliance with surveillance recommendations is poor, with fewer than 50% of patients undergoing surveillance EUS as recommended.

Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial.

BACKGROUND: Use of a stylet during EUS-guided FNA (EUS-FNA) is believed to improve the quality and diagnostic yield of specimens. OBJECTIVE: To compare samples obtained by EUS-FNA with (S+) and without (S-) a stylet for diagnostic yield of malignancy and cytological characteristics. DESIGN: Randomized, controlled trial. SETTING: Tertiary referral center. PATIENTS: Consecutive patients referred for EUS-FNA of solid lesions. INTERVENTION: EUS-FNA; the number of passes was determined by lesion site (6 pancreas/others and 4 lymph nodes). MAIN OUTCOME MEASUREMENTS: Diagnostic yield of malignancy and degree of cellularity, specimen adequacy, contamination, and amount of blood. RESULTS: One hundred patients were prospectively enrolled in this randomized, controlled trial and the sites of EUS-FNA were the pancreas, 58; lymph node, 25; and other, 17. The overall diagnosis was malignancy in 56, benign in 30, suspicious/atypical in 7, and inadequate specimen in 7 lesions. There were 550 passes made (275 with a stylet and 275 without a stylet). Interim analysis demonstrated no difference in the diagnostic yield of malignancy (94 passes with a stylet [34.2%] vs 110 without a stylet [40%], P = .2) and in the proportion of inadequate specimens (57 with a stylet [20.7%] vs 64 without a stylet [23.3%], P = .2). There was no difference with regard to cellularity (P = .83), contamination (P = .31), number of cells (P = .25), and amount of blood (P = .6). Similar results were noted in a subgroup analysis based on lesion site. Applying the rules of futility, the study was terminated. LIMITATIONS: Subjectivity in cytopathologists' assessment, endosonographer not blinded. CONCLUSIONS: There was no difference in the diagnostic yield of malignancy or proportion of inadequate specimens between passes with and without a stylet. These results suggest that the use of a stylet does not confer any advantage during EUS-FNA.

Training in EUS-Guided Fine Needle Aspiration: Safety and Diagnostic Yield of Attending Supervised, Trainee-Directed FNA from the Onset of Training.

Background. The optimal time to initiate hands-on training in endoscopic ultrasound fine needle aspiration (EUS-FNA) is unclear. We studied the feasibility of initiating EUS-FNA training concurrent with EUS training. Methods. Three supervised trainees were instructed on EUS-FNA technique and allowed hands-on exposure from the onset of training. The trainee and attending each performed passes in no particular order. During trainee FNA, the attending provided verbal instruction as needed but no hands-on assistance. A blinded cytopathologist assessed the adequacy (cellularity) and diagnostic yield of individual passes. Primary outcomes compared cellularity and diagnostic yield of attending versus fellow FNA passes. Results. We analyzed 305 FNA sites, including pancreas (51.2%), mediastinal/upper abdominal lymph node (LN) (28.5%) and others (20.3%). The average proportion of fellow passes with AC was similar to attending FNA-pancreas: 70.3 versus 68.8%; LN: 79.0 versus 81.7%; others 65.5 versus 68.7%; P > 0.05); these did not change significantly during the training period. Among cases with confirmed malignancy (n = 179), the sensitivity of EUS-FNA was 78.8% (68.4% fellow-only versus 69.6% attending only). There were no EUS-FNA complications. Conclusions. When initiated at the onset of EUS training, attending-supervised, trainee-directed FNA is safe and has comparable performance characteristics to attending FNA.

Fiducial placement for stereotactic radiation by using EUS: feasibility when using a marker compatible with a standard 22-gauge needle.

BACKGROUND: Stereotactic radiation by using fiducial markers permits higher doses of radiation while reducing the exposure of uninvolved, adjacent structures. EUS has been used to deploy fiducials, although a 19-gauge needle has traditionally been required. OBJECTIVE: To report a new technique and the feasibility of deploying a fiducial compatible with a 22-gauge needle under EUS guidance. DESIGN: Single-center, case series. SETTING: Tertiary care referral center. PATIENTS: Thirteen patients with primary or metastatic cancer referred for stereotactic radiation. INTERVENTIONS: EUS-guided placement of a single fiducial marker that is compatible with a 22-gauge EUS-FNA needle. MAIN OUTCOME MEASUREMENTS: Technical success and complications. RESULTS: Thirteen patients referred for EUS-guided placement of a fiducial marker were identified in the endoscopic database. Targeted lesions measured 27 +/- 13 mm (range 8-50) x 21 +/- 10 mm (range 6-42). All fiducials were successfully deployed, 9 using a transgastric and 4 using a transduodenal approach. There were no EUS-associated complications. Two patients did not proceed to radiation therapy as a result of interval peritoneal metastasis. However, all fiducials were visible on the roentogram. Eleven of 13 patients (85%) required placement of 1 fiducial, whereas 2 patients (15%) required 2 fiducials. LIMITATIONS: Uncontrolled feasibility study with limited sample size and follow-up. CONCLUSION: EUS-guided placement of a fiducial using a 22-gauge needle is technically feasible and may permit greater access compared with the 19-gauge needle technique.

Reliability of gross visual assessment of specimen adequacy during EUS-guided FNA of pancreatic masses.

BACKGROUND: In many centers, on-site cytopathologists are not available during EUS-guided FNA (EUS-FNA) examinations. Often, endosonographers request that technologists assess the adequacy of FNA by gross inspection of the slides. To date, there has not been a study that assessed the accuracy of experienced technologists in predicting tissue sampling adequacy by gross inspection before cytologic staining. OBJECTIVES: To assess a grading system used by cytotechnologists and EUS technologists during gross inspection of FNA slides in reliably predicting specimen adequacy compared with the final cytologic diagnoses. DESIGN: Prospective, double-blind, controlled study. SETTING: Academic tertiary-referral center with a high-volume EUS practice. PATIENTS: Fifty-one patients with a suspected solid pancreatic mass who were undergoing planned EUS-FNA. MAIN OUTCOME MEASUREMENTS: The degree of correlation in the assessment of specimen adequacy as exhibited by a weighted kappa statistic between 2 groups of technologists and a board-certified cytopathologist. RESULTS: FNA was performed in 37 cases with 234 individual slide specimens available for analysis. Only fair agreement was observed between cytotechnologists and EUS technologists versus final cytopathologic assessment of adequacy (kappa 0.20 and 0.19, respectively). The routine practice of 6 to 7 FNA passes yielded adequate tissue for assessment in 36 of 37 patients (97%). LIMITATIONS: Interobserver variability, single center, and findings applicable only to solid pancreatic lesions. CONCLUSIONS: Neither trained EUS technologists nor cytotechnologists were able to provide a reliable assessment of pancreatic-mass FNA adequacy by using gross visual inspection of the specimen on a slide. Rapid on-site cytopathology reduced the number of passes, ensured specimen adequacy, provided definitive diagnosis, and should be used in centers where available.

Routine positron emission tomography does not alter nodal staging in patients undergoing EUS-guided FNA for esophageal cancer.

BACKGROUND: Although EUS-guided FNA (EUS-FNA) and 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET) are both used in the staging of esophageal cancer, the utility of routinely performing both tests is unclear. OBJECTIVES: The primary aim of the study was to determine the benefit of routine FDG-PET for esophageal cancer nodal staging in patients undergoing EUS-FNA. The secondary objective was to determine EUS criteria that selectively identify patients in whom PET yields additional information. DESIGN: Retrospective chart review. SETTING: Tertiary-care academic medical center. PATIENTS AND INTERVENTIONS: All patients who underwent both EUS and PET for initial staging of esophageal cancer between April 2003 and August 2007. MAIN OUTCOME MEASUREMENTS: EUS and PET detection of malignant lymph nodes and distant metastases. RESULTS: Of 242 patients who underwent esophageal EUS for a malignant indication, 148 also underwent PET within 30 days. EUS detected locoregional-node disease by EUS criteria or cytology in 92 patients, and PET was positive in a minority of these patients (n = 41 [45%]). For celiac-node staging, PET was positive in 2 of 17 patients (12%) with celiac-node involvement detected by EUS. EUS was also significantly more sensitive than PET in the detection of nodal disease confirmed by cytology or histology (86% vs 44%). PET did not alter nodal staging in any patient with complete EUS-FNA. PET identified distant metastases only in those patients with incomplete EUS or nodal disease detected by EUS. LIMITATIONS: Single institution, retrospective analysis. CONCLUSIONS: The addition of PET to a complete EUS examination did not alter regional-node or celiac-node staging. PET performance in overall staging is strongly associated with EUS assessment of lymph nodes.