Randomized Controlled Trial
Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Aug 7, 2014; 20(29): 10151-10157
Published online Aug 7, 2014. doi: 10.3748/wjg.v20.i29.10151
Table 1 Comparison of the two groups of patients according to patient and investigation characteristics (n = 665) n (%)
Patient and investigation characteristicsIndomethacin group(n = 347)Control group(n = 318)
Gender
Male (n = 239)133 (55.64)106 (44.35)
Female (n = 426)214 (50.23)212 (49.76)
Age
< 70 yr (n = 355)190 (53.52)165 (46.48)
> 70 yr (n = 310)157 (50.65)153 (49.35)
BMI
< 25 (n = 303)156 (51.48)147 (48.51)
25-30 (n = 236)125 (53.96)111 (47.03)
> 30 (n = 126)66 (52.38)60 (47.62)
Duration of ERCP
< 20 min (n = 454)236 (52.0)218 (48.0)
> 20 min (n = 211)111 (52.6)100 (47.4)
Dilated/non-dilated bile duct
Dilated (n = 366)189 (51.64)177 (48.36)
Non-dilated (n = 299)158 (52.84)141 (47.15)
Pancreatic duct opacification (n = 463)246 (53.13)217 (46.87)
EST
Biliary (n = 443)224 (50.56)219 (49.43)
Pancreatic/double (n = 48)22 (44.0)28 (56.0)
Difficult cannulation (n = 116)64 (55.17)52 (44.83)
Gallstone extraction (n = 165)82 (49.7)83 (50.3)
Bile duct dilatation (n = 22)11 (50.0)11 (50.0)
Biliary stent placement
Plastic stent (n = 75)35 (46.7)40 (53.3)
Metal stent00
Table 2 Distribution of specific risk factors in the investigated population (n = 665) n (%)
Risk factorsIndomethacingroup (n = 347)Control group(n = 318)P value
Age < 50 yr (n = 104)57/347 (16.4)47/318 (14.8)0.559
Female gender (n = 426)214/347 (61.7)212/318 (66.7)0.180
BMI > 25 (n = 362)191/347 (55.0)171/318 (53.8)0.743
Duration of ERCP > 20 min (n = 211)111/347 (32.0)100/318 (31.4)0.880
Non-dilated bile duct (n = 299)158/347 (45.5)141/318 (44.3)0.757
Pancreatic duct opacification (n = 463)246/347 (70.1)217/318 (68.2)0.534
EST biliary (n = 443)224/347 (64.6)219/318 (68.9)0.195
EST pancreatic/double (n = 48)20/347 (5.8)28/318 (8.8)0.130
Difficult cannulation (n = 116)64/347 (18.4)52/318 (16.4)0.111
Gallstone extraction (n = 165)82/347 (23.6)83/318 (26.1)0.461
Bile duct dilatation (n = 22)11/347 (3.2)11/318 (3.5)0.835
Biliary plastic stent placement (n = 75)35/347 (10.1)40/318 (12.6)0.640
Total (n = 2734)1413/4164 (33.9)1321/3816 (34.6)0.520
Table 3 Incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis and hyperamylasaemia (n = 665)
Group of patientsERCP (n)Pancreatitis (n)PancreatitisHyperamylasaemia (n)Hyperamylasaemia
Indomethacin34720 (mild: 16, severe: 4)5.76%8123.34%
Control31822 (mild: 18, severe: 4)6.92%7924.84%
Total665426.32%16024.06%
Table 4 Incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis according to risk factors (n = 665) n (%)
Risk factorsIndomethacingroupControl groupP value
Age < 50 yr (n = 104)5/57 (8.77)6/47 (12.76)0.365
Female gender (n = 426)16/214 (7.47)19/212 (8.96)0.576
BMI > 25 (n = 362)12/191 (6.28)10/171 (5.85)0.862
Duration of ERCP > 20 min (n = 211)8/111 (7.2)7/100 (7.0)0.580
Non-dilated bile duct (n = 299)10/158 (6.33)11/141 (7.8)1.000
Pancreatic duct opacification (n = 463)20/246 (8.13)20/217 (9.21)0.263
EST biliary (n = 443)14/224 (6.25)14/219 (6.4)0.951
EST pancreatic/double (n = 48)4/20 (20.0)5/28 (17.86)0.560
Difficult cannulation (n = 116)4/64 (6.25)6/52 (11.54)0.478
Gallstone extraction (n = 165)3/82 (3.66)5/83 (6.02)0.451
Bile duct dilatation (n = 22)1/11 (9.1)2/11 (18.2)0.537
Biliary plastic stent placement (n = 75)4/35 (11.43)3/40 (7.5)0.580