New horizons in the endoscopic ultrasonography-based diagnosis of pancreatic cystic lesions

Table 2 Needle-based confocal laser endomicroscopy in pancreatic cystic lesions

Authors	Study	n	Main outcomes	Complications
Konda et al[48], 2011	P	16	94% Technical success (feasibility study)	12% post-procedure pancreatitis
Konda et al[49], 2013	P	66	Stage 1: Description of visualized structures (n = 26) with histological correlation Stage 2: Performance assessment of defined criteria (n = 31): Villous pattern: Sen 59%, Spe 100%, PPV 100%, NPV 50%, A 71% for PCNs Significant association with PCNs (aP = 0.004)	3% post-procedure pancreatitis 4.5% intracystic self-limited bleeding
Nakai et al[50], 2015	P	30	Villous pattern in 18 patients with highly certain diagnosis: Sen 80%, Spe 100%, PPV 100%, NPV 80%, A 89% for mucinous cysts Significant association with mucinous cysts (bP = 0.001)	7% post-procedure (cystoscopy followed by nCLE) pancreatitis
Napoléon et al[51], 2015	P	31	Superficial vascular network: Sen 69%, Spe 100%, PPV 100%, NPV 82%, A 87% for SCAs	3% post-procedure pancreatitis
Napoléon et al[52], 2016	R	31	Step 1: Description of nCLE patterns for mucinous cysts, PCs and cystic NENs with histological correlation Step 2: Retrospective external validation of nCLE criteria Accuracy 94% for mucinous cysts (90% IPMN - 90% MCA) - 87% SCA - 87% PCs Substantial global IOA: Perfect PC, almost perfect SCA, moderate IPMN, fair MCA
Kadayifci et al[53], 2017	P	20	nCLE performance for mucinous cysts: Sen 66% -Spe 100% -A 80%	0 complications
Krishna et al[54], 2017	P	10	Reproducibility of the in vivo nCLE criteria in ex vivo specimens
Napoléon et al[55], in press	P	209	Diagnostic yield 91% in 78 patients with non-communicating cysts and pathological diagnosis: Sen 95%, Spe 100% - PPV 100% - NPV 98% - A 99% for SCAs Sen 95%, Spe 100% - PPV 100% - NPV 94% - A 97% for mucinous cysts Sen 100%, Spe 95% - PPV 70% - NPV 100% - A 96% for NENs Sen 96%, Spe 95% - PPV 98% - NPV 91% - A R96% for premalignant cysts	1.3% post-procedure pancreatitis
Karia et al[56], 2016	R	15	IOA poor to fair for all nCLE variables
Krishna et al[57], 2016	R	49	nCLE performance on 26 patients with definitive diagnosis (23 with pathological diagnosis): Sen 94%, Spe 82% - PPV 88% - NPV 92% - A 89% for mucinous cysts IOA and IOR: Substantial for all nCLE criteria	6.1% post-procedure pancreatitis
Krishna et al[58], 2017	R	29	nCLE performance on 29 patients with definitive diagnosis (23 with pathological diagnosis): Sen 95%, Spe 94% - A 95% for mucinous cysts Sen 99%, Spe 98% - A 98% for SCAs Sen 99%, Spe 98% - A 98% for NENs IOA and IOR: Almost perfect for mucinous cysts and SCAs

P: Prospective; R: Retrospective; Sen: Sensitivity; Spe: Specificity; PPV: Positive predictive value; NPV: Negative predictive value; A: Accuracy; PCNs: Pancreatic cystic neoplasms; PC: Pseudocyst; MCA: Mucinous cystadenoma; SCA: Serous cystadenoma; IPMN: Intraductal papillary mucinous neoplasm; NENs: Neuroendocrine neoplasm; IOA: Interobserver agreement; IOR: Intraobserver reliability.