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DOI: 10.1055/s-0039-1681295
LEOPARD STUDY: ITALIAN MULTICENTER PROSPECTIVE STUDY OF PANCREATIC CYSTIC LESIONS WITH CONFOCAL ENDOMICROSCOPY: FEASIBILITY AND SAFETY EVALUATION
Publication History
Publication Date:
18 March 2019 (online)
Aims:
Despite significant improvements in imaging technology, the diagnosis and management of pancreatic cystic lesions remains a significant clinical challenge. Needle-based confocal laser endomicroscopy (nCLE) is a unique imaging technique, enabling microscopic observation of solid organs and cystic tumors, in vivo and in real-time, during an EUS-FNA procedure.
This multicenter prospective study evaluates the feasibility and safety of nCLE during EUS-FNA of pancreatic cystic lesions.
Methods:
59 patients presenting for EUS-FNA of pancreatic cyst were enrolled for nCLE examination. The nCLE procedures were performed using the AQ-Flex 19 preloaded in a 19G EUS FNA needle. After IV injection of fluorescein, (2.5 mL of 10% fluorescein) confocal images were acquired then the probe was retrieved from the needle, and fluid acquisition was performed as appropriate for cytology and tumor markers (CEA, Amylase). Adverse events were recorded either during or after the procedure (immediate, within 24 hours and delayed) and classified in mild, severe (according to the requirement of specific care) and fatal.
Results:
59 cases were enrolled, including 23 cysts located in head/uncinate (40%) of pancreas and in 53% of cases the cyst was unilocular. In 56 cases (95%) the procedure was technically feasible and in 81% was considered “easy” by operator. 3 cases were considered as procedure's failure, one case due to device malfunction and 2 cases due to impossibility to retrieve the probe at the end of nCLE imaging acquisition. 6 (10%) adverse events occurred after the procedure: 3 severe (acute pancreatitis), 3 mild (2 intracystic self-limiting bleeding and 1 cyst infection); the cases of acute pancreatitis only required patient hospitalization.
Conclusions:
Our study demonstrates an excellent feasibility rate and an acceptable safety profile for nCLE in the pancreatic cysts via a 19G needle under EUS guidance.