New anti-reflux plastic stent to reduce the risk of stent-related cholangitis in the treatment of biliary strictures

Table 3 Outcomes in the anti-reflux plastic stent group and traditional plastic stent group

	ARPS group, n = 67	TPS group, n = 66	P value
ERCP-related complications, n (%)	5 (7.5)	3 (4.5)	0.7184
Pancreatitis	4 (6.0)	2 (3.0)	1.0004
MBS/BBS	3/1	1/1
Cholangitis	1 (1.5)	1 (1.5)	1.0004
MBS/BBS	1/0	1/0
Stent-related cholangitis, n (%)	8 (11.9)	18 (27.3)	0.0303
MBS	7 (14.6)	13 (31.0)	0.0783
BBS	1 (5.3)	5 (20.8)	0.2053
Stent-related cholangitis, frequencies			0.1154
0	59	48
1	6	12
2	2	5
3	0	1
Time till the onset of first stent-related cholangitis, d1	128.5 (197.5); [65.0-347.0]	76.0 (72.8); [5.0-337.0]	0.0395
Stent distal migration, n (%)	3 (4.5)	4 (6.0)	0.7184
MBS/BBS	2/1	2/2
Stent dysfunction, n (%)	44 (65.7)	52 (78.8)	0.0913
MBS/BBS	29/15	33/19
Stent patency, d2	185.0 (8.6); [168.2-201.8]	133.0 (16.9); [99.8-166.2]	0.0016
MBS	173.0 (32.0); [110.3-235.7]	98.0 (11.6); [75.3-120.7]	0.0086
BBS	210.0 (23.8); [163.4-256.6]	155.0 (6.0); [143.3-166.8]	0.0496

¹Median (interquartile range) [range].

²Median (standard error) [95% confidence interval].

³Chi-squared test.

⁴Fisher’s exact test.

⁵Mann-Whitney U test.

⁶Log-rank test. ARPS: Anti-reflux plastic stent; TPS: Traditional plastic stent; ERCP: Endoscopic retrograde cholangiopancreatography; MBS: Malignant biliary stricture; BBS: Benign biliary stricture.