Abstract Background Pancreatic intraductal papillary mucinous neoplasms (IPMNs) carry malignant risk and they account for up to 7% of pancreatic neoplasms, hence it is crucial to identify high-risk lesions to determine timely therapy Distinction between main duct-IPMN (MD-IPMN) and other pancreatic disorders often relies on endoscopic ultrasound, MRI, and CT findings. These findings are very accurate in advanced cases, yet they are less sensitive for the diagnosis of early lesions Direct endoscopic visualization of the biliary and pancreatic ducts has gained an increased interest due to the development of single-operator scopes with a better image resolution. Several case series and a retrospective single-center cohort study report the beneficial role of single operator pancreatoscopy (SOP) in the evaluation and sampling of indeterminate PD lesions Aims Evaluate our experience with SOP and determine its 1.Efficacy and safety in diagnosing MD-IPMN and PD neoplasia 2.Sensitivity (Sn) and specificity (Sp) in diagnosing high risk PD lesions Methods All patients (age ≥18 year old) who had attempted SOP using the SpyGlass (Boston Scientific Corp, Natick, MA) between June 2013 and November 2019 for the evaluation of indeterminate main PD strictures, dilatation, or with suspected or known MD-IPMN were included The primary outcome was the efficacy and safety of SOP in diagnosing high-risk PD lesions A minimum of 12 months follow-up (F/U) from index SOP was required to define a true negative for patients (pts) with benign SOP findings Results A total of 43 pts underwent SOP; 18 (42%) males and 25 (58%) females, with a mean age of 66.1 years. Technical success was (n=35/43; 81.4%) In the diagnosed MD-IPMN group (n=14/35; 40%), all underwent surgery except three; one is awaiting surgery, the second had an aborted Whipple’s and the last was lost to F/U. The remaining eleven pts (78.6%) had confirmed diagnosis of MD-IPMN with moderate or high-grade dysplasia, or pancreatic cancer Of those who had benign SOP findings (n=21), nineteen (90.5%) did not develop pancreatic neoplasm during a mean F/U period of 59.3 months (range 13 to 84 months). One Pt developed mild pancreatitis Conclusions This study suggests that SOP is a safe, effective and feasible procedure that should be considered in the diagnostic algorithm of indeterminate main PD strictures, dilatation, or those with suspected or known MD-IPMN with or without side branch involvement. We demonstrate a high technical success rate, Sn, and Sp of 81.4%, 100%, and 100%, respectively If all pts with incomplete outcomes data are considered to have be diagnostically inaccurate, the Sn and Sp remain high at 81.4% and 86.4% respectively. The adverse events seem similar to ERCP with only one Pt. (2.7%) developed mild pancreatitis, although this sample has insufficient numbers to evaluate rare events Funding Agencies None
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