Randomized Controlled Trial
Copyright ©The Author(s) 2019.
World J Gastroenterol. May 21, 2019; 25(19): 2373-2382
Published online May 21, 2019. doi: 10.3748/wjg.v25.i19.2373
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), years70.3 (13.1)73.8 (14.6)0.452a
Sex, male/female, n12/714/40.476b
Diagnosis, n (%)
Pancreatic cancer9 (47.4)6 (33.3)0.753b
Cholangiocarcinoma7 (36.8)9 (50)
Ampullary cancer3 (15.8)3 (16.7)
Distant metastasis, n (%)9 (47.4)7 (38.9)0.743b
Comorbidity, n (%)d12 (63.2)14 (77.8)0.476b
Adjuvant therapy, n (%)6 (31.6)7 (38.9)
Chemotherapy3 (50.0)2 (28.6)0.790b
Radiotherapy1 (16.7)3 (42.9)
Radiochemotherapy2 (33.3)2 (28.6)
Initial laboratory results
Total bilirubin, median (IQR), µmol/L234.6 (284.4)206.7 (215.9)0.761c
Direct bilirubin, median (IQR), µmol/L210.2 (232.6)191.30 (192.1)0.671c
Length of stricture, median (IQR), cm3 (2)3 (2)0.975c
Length of stent, median (IQR), cm7 (2)7 (3)0.585c
Sphincterotomy, yes, n (%)10 (52.6)5 (27.8)0.184b
Lost to follow–up, n (%)01 (5.6)1.000b
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)
Cholangitis111.000a
Mild pancreatitis11
Late adverse event, n (%)
Mild pancreatitis1 (5.3)01.000a
Stent dysfunction, n (%)12 (63.2)15 (83.3)0.269a
Stent patency, median (IQR), d285 (170)130 (90)0.005b
Mortality, n (%)17 (89.5)16 (88.9)0.677a
Patient survival, median (IQR), d195 (297)182 (229)0.900b