Retrospective Cohort Study
Copyright ©The Author(s) 2017.
World J Gastrointest Endosc. Aug 16, 2017; 9(8): 389-395
Published online Aug 16, 2017. doi: 10.4253/wjge.v9.i8.389
Table 1 Baseline characteristics n (%)
Biopsy/surgical specimen diagnosis
P value
Total (n = 144)Neoplastic lesions (n = 41)Non-neoplastic lesions (n = 103)
Sex (female)74 (51.4)19 (46.3)55 (53.4)0.445
Age, yr, mean ± SD51.33 ± 16.556.73 ± 17.149.19 ± 15.80.014
Initial endoscopy indication< 0.001
Suspected tumor70 (48.6)32 (78.0)38 (36.9)
Other74 (51.4)9 (22.0)65 (63.1)
Location0.187
Vater ampulla2 (1.4)1 (2.4)1 (1.0)
Colon14 (9.7)6 (14.6)8 (7.8)
Duodenum4 (2.8)1 (2.4)3 (2.9)
Esophagus24 (16.7)8 (19.5)16 (15.5)
Stomach59 (41.0)10 (24.4)49 (47.6)
Ileum1 (0.7)0 (0.0)1 (1.0)
Pancreas8 (5.6)1 (2.4)7 (6.8)
Rectum3 (2.1)1 (2.4)2 (1.9)
Bile duct29 (20.1)13 (31.7)16 (15.5)
Table 2 Confocal laser endomicroscopy overall diagnostic accuracy with either confocal laser endomicroscopy target biopsy or surgical specimens as the Gold Standard n (%)
Biopsy/surgical specimen diagnosis
P value
Total (n = 144)Neoplastic lesions (n = 41)Non-neoplastic lesions (n = 103)
CLE diagnosis< 0.001
Neoplastic lesion48 (33.3)35 (85.4)13 (12.6)
Non-Neoplastic lesion96 (66.7)6 (14.6)90 (87.4)
CLE overall diagnostic accuracy
Sensitivity, n/T (%; 95%CI)35/41(85.37; 70.83-94.43)
Specificity, n/T (%; 95%CI)90/103(87.38; 79.38-93.11)
PPV, n/T (%; 95%CI)35/48(72.92; 61.46-81.97)
NPV, n/T (%; 95%CI)90/96(93.75; 87.71-96.93)
Observed agreement, n/T (%)125/144-86.81
Cohen’s Kappa, % (95%CI)69.2(56.50-81.90)
Table 3 Patients with changes in management following biopsy/surgical specimen diagnosis, listed according to organ n (%)
Biopsy/surgical specimen diagnosis
P value
Total (n = 78)Neoplastic lesions (n = 30)Non-neoplastic lesions (n = 48)
Location0.707
Vater ampulla1 (1.3)1 (3.3)0
Colon9 (11.5)4 (13.3)5 (10.4)
Duodenum4 (5.1)1 (3.3)3 (6.3)
Esophagus10 (12.8)5 (16.7)5 (10.4)
Stomach17 (21.8)5 (16.7)12 (25)
Ileum1 (1.3)01 (2.1)
Pancreas6 (7.7)1 (3.3)5 (10.4)
Rectum3 (3.8)1 (3.3)2 (4.2)
Bile duct27 (34.6)12 (40)15 (31.3)