Efficacy and safety of disposable digital single-operator cholangioscopy: A noninferiority, multicenter, randomized, open-label, blinded endpoint trial

Table 6 Cholangioscopy performance scored by operator, n (%)

Performance metrics	DSOC group	FSOC group	P value
Insertion			< 0.0001
1	0 (0.00)	0 (0.00)
2	0 (0.00)	0 (0.00)
3	0 (0.00)	0 (0.00)
4	14 (24.14)	43 (76.79)
5	44 (75.86)	13 (23.21)
Withdrawal			< 0.0001
1	0 (0.00)	0 (0.00)
2	0 (0.00)	0 (0.00)
3	0 (0.00)	0 (0.00)
4	11 (18.97)	41 (73.21)
5	47 (81.03)	15 (26.79)
Sealing			0.0090
1	0 (0.00)	0 (0.00)
2	3 (5.17)	0 (0.00)
3	5 (8.62)	15 (26.79)
4	50 (86.21)	41 (73.21)
Angulation			< 0.0001
1	0 (0.00)	0 (0.00)
2	0 (0.00)	0 (0.00)
3	3 (5.17)	8 (14.29)
4	19 (32.76)	37 (66.07)
5	36 (62.07)	11 (19.64)
Accessory insertion and withdrawal			0.2923
1	0 (0.00)	0 (0.00)
2	0 (0.00)	0 (0.00)
3	2 (6.25)	2 (5.71)
4	14 (43.75)	22 (62.86)
5	16 (50.00)	11 (31.43)
Accessory compatibility			0.0016
1	0 (0.00)	0 (0.00)
2	0 (0.00)	0 (0.00)
3	4 (12.50)	2 (5.71)
4	9 (28.12)	25 (71.43)
5	19 (59.38)	8 (22.86)

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.