New antireflux plastic stent for patients with distal malignant biliary obstruction

Table 1 Baseline patient characteristics and clinical information of the antireflux plastic stent group and traditional plastic stent group

	ARPS group (n = 19)	TPS group (n = 18)	P-value
Age, mean (SD), years	70.3 (13.1)	73.8 (14.6)	0.452a
Sex, male/female, n	12/7	14/4	0.476b
Diagnosis, n (%)
Pancreatic cancer	9 (47.4)	6 (33.3)	0.753b
Cholangiocarcinoma	7 (36.8)	9 (50)
Ampullary cancer	3 (15.8)	3 (16.7)
Distant metastasis, n (%)	9 (47.4)	7 (38.9)	0.743b
Comorbidity, n (%)d	12 (63.2)	14 (77.8)	0.476b
Adjuvant therapy, n (%)	6 (31.6)	7 (38.9)
Chemotherapy	3 (50.0)	2 (28.6)	0.790b
Radiotherapy	1 (16.7)	3 (42.9)
Radiochemotherapy	2 (33.3)	2 (28.6)
Initial laboratory results
Total bilirubin, median (IQR), µmol/L	234.6 (284.4)	206.7 (215.9)	0.761c
Direct bilirubin, median (IQR), µmol/L	210.2 (232.6)	191.30 (192.1)	0.671c
Length of stricture, median (IQR), cm	3 (2)	3 (2)	0.975c
Length of stent, median (IQR), cm	7 (2)	7 (3)	0.585c
Sphincterotomy, yes, n (%)	10 (52.6)	5 (27.8)	0.184b
Lost to follow–up, n (%)	0	1 (5.6)	1.000b

^aStudent’s t-test;

^bFisher’s exact test;

^cMann-Whitney U-test;

^dHypertension, coronary artery disease, diabetes mellitus, chronic obstructive pulmonary disease, liver cirrhosis, rheumatoid arthritis, and other neoplastic diseases. ARPS: Antireflux plastic stent; TPS: Traditional plastic stent; SD: Standard deviation; IQR: Interquartile range.

Table 2 Outcomes of the antireflux plastic stent group and the traditional plastic stent group

	ARPS group(n = 19)	TPS group(n = 18)	P-value
Technical success, n (%)	19 (100)	18 (100)	-
Clinical success, n (%)	17 (89.5)	15 (83.3)	0.660a
Early adverse events, n (%)	2 (10.5)	2 (11.1)
Cholangitis	1	1	1.000a
Mild pancreatitis	1	1
Late adverse event, n (%)
Mild pancreatitis	1 (5.3)	0	1.000a
Stent dysfunction, n (%)	12 (63.2)	15 (83.3)	0.269a
Stent patency, median (IQR), d	285 (170)	130 (90)	0.005b
Mortality, n (%)	17 (89.5)	16 (88.9)	0.677a
Patient survival, median (IQR), d	195 (297)	182 (229)	0.900b

^aFisher exact test;

^bLog-rank test. ARPS: Antireflux plastic stent; TPS: Traditional plastic stent; IQR: Interquartile range.