Maria M. Romanas

A prospective, single-blind, randomized, controlled trial of EUS-guided FNA with and without a stylet.

BACKGROUND Most endosonographers use an EUS needle with an internal stylet during EUS-guided FNA (EUS-FNA). Reinserting the stylet into the needle after every pass is tedious and time-consuming, and there are no data to suggest that it improves the quality of the cytology specimen. OBJECTIVE To compare the samples obtained by EUS-FNA with and without a stylet for (1) the degree of cellularity, adequacy, contamination, and amount of blood and (2) the diagnostic yield of malignancy. DESIGN Prospective,single-blind, randomized, controlled trial. SETTING Two tertiary care referral centers. PATIENTS Patients referred for EUS-FNA of solid lesions. INTERVENTION Patients underwent EUS-FNA of the solid lesions, and 2 passes each were made with a stylet and without a stylet in the needle. The order of the passes was randomized, and the cytopathologists reviewing the slides were blinded to the stylet status of passes. MAIN OUTCOME MEASUREMENTS Degree of cellularity, adequacy, contamination, amount of blood, and the diagnostic yield of malignancy in the specimens. RESULTS A total of 101 patients with 118 lesions were included in final analysis; 236 FNA passes were made, each with and without a stylet. No significant differences were seen in the cellularity (P = .98), adequacy of the specimen (P = .26), contamination (P = .92), or significant amount of blood (P = .61) between specimens obtained with and without a stylet. The diagnostic yield of malignancy was 55 of 236 specimens (23%) in the with-stylet group compared with 66 of 236 specimens (28%) in the without-stylet group (P = .29). LIMITATIONS Endosonographers were not blinded to the stylet status of the passes. CONCLUSIONS Using a stylet during EUS-FNA does not confer any significant advantage with regard to the quality of the specimen obtained or the diagnostic yield of malignancy. ( CLINICAL TRIAL REGISTRATION NUMBER NCT 01213290).

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.

Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound–Guided Fine-Needle Aspiration

BACKGROUND & AIMS It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound–guided fine‐needle aspiration (EUS‐FNA). We aimed to define the per‐pass diagnostic yield of EUS‐FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies. METHODS In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS‐FNA, with the number of passes determined by an on‐site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow‐up evaluation at least 1 year after EUS‐FNA. The cumulative sensitivity of detection of malignancy by EUS‐FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings. RESULTS Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS‐FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%–98%); 4 passes of EUS‐FNA detected malignancies with 92% sensitivity (95% CI, 87%–95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9–31.6). In masses larger than 2 cm, 4 passes of EUS‐FNA detected malignancies with 93% sensitivity (95% CI, 89%–96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%–93%). Sensitivity of detection did not increase with increasing number of passes. CONCLUSIONS In a prospective study, we found 4 passes of EUS‐FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931.

Su1136 Cost Minimization Analysis of Onsite Cytopathologist (CyP) Evaluation During EUS-FNA of Solid Pancreatic Lesions: Results From a Multicenter Prospective Randomized Controlled Trial

had familiar history ofIBD.Among the 93 IBD pts with arthralgias, rheumatologic assessment diagnosed rheumatologic diseases in 33 (88%) UC and in 44 (80%) CD pts. In particular, a diagnosis of SpAewas made in 50 (54%) IBD pts(54% peripheral SpA, 24%, axial SpA, 22% both), 24 (26%)Osteoarthritis, 6 (7%)Fybromialgia,3 (3%), Gout, 3 (3%)Rheumatoid Arthritis, 2 (2%) Psoriatic Arthritis, while diagnosis was inconclusive in 5 (6%) pts. After rheumatological assessment, a higher percentage of IBD pts were treated with diseasemodifying anti-rheumatic drugs (including anti-TNFs)(5.3% vs 15%, p=0.03, RR 1.6)and/ or with anti-COX2 (6.4% vs 27%; p<0.0001; RR 2.3). Anti-TNFs use also significantly increased (19% vs 34%, p=0.009;RR 1.8).Conclusions. Multidisciplinary IBD care including rheumatologists may facilitate the diagnosis and management of arthralgias in IBD. A combined multidisciplinary approach may also lead to an early diagnosis and proper treatment of chronic and debilitating inflammatory arthritis.

W1955 Pancreatic Endocrine Neoplasms: Predictive Cytomorphologic Features and Diagnostic Accuracy of Endoscopic Ultrasound-Guided Fine Needle Aspiration

Introduction: Pancreatic endocrine neoplasms (PENs) are rare lesions with an estimated frequency of 1 per 100,000. An accurate diagnosis of PEN depends on characteristic cytomorphologic criteria in combination with clinical and radiologic findings, including the use of Endoscopic ultrasonography-guided fine needle aspiration cytology (EUS-FNA). Aims: To evaluate the diagnostic reliability of for PENs at our institution and attempt to identify cytomorphologic features that predict aggressive clinical behavior. Methods: A total of 774 EUS-FNA pancreatic cases were retrieved from the files at KU Medical Center for the years 2002 to 2008. Of these, 34 cases (4%) were diagnosed as positive or suspicious for PENs. The cytologic features used as diagnostic criteria included clusters of monotonous small uniform cells, singly dispersed or loosely cohesive plasmacytoid cells (on Diff-Quik stained smears), scant to moderate granular cytoplasm, and stripped nuclei in a granular background. Of these, thirteen cases (8 females) had surgical or clinical follow-up in our institution. Cytomorphologic features were correlated with the clinical behavior of each tumor. The cytomorphologic features evaluated included cellularity, nuclear pleomorphism, macronucleoli, mitotic activity and tumor diathesis. Results: Mean age of the patients in this cohort was 56 years (range: 9-79). Cytology samples obtained by EUS showed PEN in all 13 patients and were subsequently confirmed by surgical pathology in 10. The mean size of the PENs was 3.1 cm (range: 0.5-8.3cm) and were distributed in the head (n=4), body (n=4), tail (n= 4), and neck (n=1) of the pancreas. Eight patients (62%) had the lesions resected with tumor free margins, 5 lesions were found to be unresectable2 secondary to invasion of portal vein (n=1) or superior mesenteric vein (n=1); 2 due to evidence of hepatic metastasis (these patients underwent palliative surgery); and 1 because of a coexisting locally advanced adenocarcinoma of unknown primary. In the surgically resected PENs, 4 were benign (3 insulinomas, 1 PPoma), and 4 were malignant islet cell tumors. The presence of tumor diathesis and mitoses correlated with malignancy, however other features such as cellularity, nuclear pleomorphism, and macronucleoli did not. Conclusion: EUS-FNA is a reliable diagnostic tool for evaluating PENs. Identification of mitoses and tumor diathesis in the smears may predict a more aggressive clinical behavior.