Table 1. Duct involvement Histology Dysplasia Grade Branch duct=16 Gastric=15 Mixed=1 Low=14 Intermediate=2 Main duct=8 Intestinal=5 Gastric=2 Pancreaticobiliary=1 Low=1 Intermediate=6 High=1 Mixed=2 Intestinal=1 Pancreaticobiliary=1 Carcinoma=2 Table 2. PATHOLOGY KRAS Mutation GNAS Mutation IPMN (26) 65% 38% MCN (11) 9% 0% PanNET (10) 0% 0% Benign Cysts (6) 17% 0% All Malignant Lesions (5; includes 2 IPMC) 100% 0% Mo1516 Does Molecular Analysis Alter Pancreatic Cyst Management? David Arner 1 , Henry C. Ho 2 , Bradley J. Weinbaum 1 , Uzma D. Siddiqui 2 , Harry R. Aslanian 2 , Reid Adams 1 , Todd W. Bauer 1 , Andrew Y. Wang 1 , Vanessa M. Shami 1 , Bryan G. Sauer* 1 1 University of Virginia, Charlottesville, VA; 2 Yale University, New Haven, CT Background: Pancreatic cyst management is determined by the malignant potential of the cystic lesion. The use of cross-sectional imaging, endoscopic ultrasound (EUS), cyst fluid characteristics (CEA and amylase) and cytology are often used to stratify lesions. It has been proposed that molecular analysis be used as an adjunctive diagnostic tool to identify lesions with malignant potential. This study was designed to evaluate whether additional data provided by molecular analysis alters the clinical management recommendations of pancreatic cysts. Methods: We performed a retrospective review of patients who had undergone EUS with fine-needle aspiration (FNA) of pancreatic cysts that included molecular analysis (kras point mutation, allelic imbalance (LOH), DNA quality/quantity-RedPath, Pittsburgh, PA) at two large academic institutions. All patients had undergone cross-sectional imaging with abdominal CT or MRI as part of their pre- procedure workup. Cyst aspirate for cytology, CEA, and amylase level when available were recorded. Two experienced pancreaticobiliary surgeons were independently given a brief clinical history, cross-sectional imaging, EUS reports, cyst fluid characteristics with cytology and asked to provide management recommendations in each case (surgery, observation, other). Cases were randomly presented again to both surgeons with the addition of cyst aspirate molecular analysis and their new management recommendations recorded. We then compared the surgeons’ recommendations with and without molecular analysis. Results: A total of 46 patients (19 male, 27 female) with a mean age of 62.0 13.4 years (range 27-79 years) were reviewed. Fourteen patients (30%) had cystic lesions in the head of the pancreas, 15 (33%) in the body, 10 (22%) in the tail, and 7 (15%) in the uncinate process. The surgeons agreed on management in 33/46 (71.7%) cases without molecular analysis and in 34/46 (73.9%) with molecular analysis. Interobserver agreement of management recommendations without molecular analysis was moderate (=0.45) and fair with molecular analysis (=0.39). With the addition of cyst fluid molecular analysis, Surgeon #1 changed management in 13 cases (13/46, 28%) and surgeon #2 changed management in 12 cases (12/46, 26%). Molecular analysis changed management more frequently (53.8%)in those with intermediate CEA levels (45-800 ng/ml) when compared to all others (p=0.0006) (Table 1). Conclusion: Moderate interobserver agreement was demonstrated in management of pancreatic cystic lesions when presented to two experienced pancreaticobiliary surgeons. Molecular analysis altered clinical management recommendation in slightly greater than 25% of individuals with pancreatic cystic lesions who underwent EUS with FNA. More frequent changes in management recommendation occurred when CEA levels were intermediate (45-800 ng/ml). Change in pancreatic cyst management with the addition of molecular analysis, stratified by CEA level All Cases (46 cases 2 surgeons) Cases with intermediate CEA levels (45-800 ng/ml) All other cases p value Change in management recommendations 25/92 (27.2%) 14/26 (53.8%) 11/66 (16.7%) 0.0006 Change to observation 18 11 7 Change to surgery 6 2 4 Change to “other 1 1 0 p value based on Fisher’s Exact test Mo1517 Needle-Based Confocal LASER Endomicroscopy Examination of Pancreatic Masses John G. Karstensen* 1 , Tatiana Cartana 2 , Hazem Hassan 1 , Dan Ionut Gheonea 2 , Carmen F. Popescu 3 , Dorte Linnemann 4 , Adrian Saftoiu 1,2 , Peter Vilmann 1 1 Department of Endoscopy, Gastrointestinal Unit, Copenhagen University Hospital Herlev, Herlev, Denmark; 2 Department of Gastroenterology, Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Craiova, Romania; 3 Department of Cytology, Emergency County Clinical Hospital Craiova, Craiova, Romania; 4 Department of Pathology, Copenhagen University Hospital Herlev, Herlev, Denmark Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of patients being alive at five years. Endoscopic ultrasound (EUS) and guided fine needle aspiration (FNA) is an established method in pancreatic masses both for diagnosis, but also for staging purposes. However, EUS-FNA has its drawbacks, due to a relatively low negative predictive value. Confocal laser endomicroscopy (CLE) has emerged in recent years as a novel method that enables in vivo microscopic analysis during ongoing endoscopy. Recently, CLE has gone beyond the superficial luminal indications with the development of a new microprobe, i.e. a flexible laser probe that can pass through a 19-gauge needle (nCLE). Combined with EUS guidance, descriptive criteria for the diagnosis of cystic pancreatic neoplasms have been developed in a multicentre trial. Nevertheless, only a limited number of cases of solid pancreatic masses have been described with nCLE.Aim and Method: To evaluate the feasibility and safety of nCLE examinations and to describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases identified during EUS procedures performed for pancreatic cancer staging (EUS-nCLE). The hypothesis was that EUS-nCLE could allow targeted tissue sampling and real-time optical diagnosis of pancreatic lesions resulting in more accurate diagnosis and staging. Twenty patients were included, all presenting with a clinical suspicion of pancreatic cancer and/or imaging studies showing a pancreatic mass. During the procedure, a nCLE preloaded 19G FNA needle was advanced into the lesion under EUS guidance. A contrast agent was administered intravenously (2.5 mL fluorescein 10%). The data was stored digitally for post procedural analysis. EUS- FNA was performed immediately after from the same location. Results: In all twenty patients nCLE were accomplished. No adverse advents were registered. Moreover, it was clearly feasible to do nCLE inside pathological lesions and obtain images of cellular structures. Floating cells were often the initial finding, but after careful manipulation of the needle, organ specific tissue was visualized during all procedures. Clearly visible were also small capillaries with floating erythrocytes. After nCLE, FNA was obtained, in order to correlate between nCLE features, cytopathology, and in some cases histopathology. Our preliminary experience on interpretation of the nCLE sequences is nevertheless scarce and establishing the criteria for diagnosis still looks challenging. Characteristic images are presented correlated to the final diagnosis. Conclusions: nCLE on pancreatic masses is feasible and safe. The endomicroscopic visuatisation of pancreatic tissue represents a novel method, but further studies are needed to establish nCLE criteria for the assessment of pancreatic mass lesions. Pancreatic tissue in a patient with chronic pancreatitis demonstrated by needle-based confocal laser endomicroscopy. Abstracts www.giejournal.org Volume 77, No. 5S : 2013 GASTROINTESTINAL ENDOSCOPY AB411