Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial

Table 1 Patient characteristics and baseline laboratory tests

Variable	Group I, n = 51	Group II, n = 51	Total, n = 102	P value
Age in yr				0.3431
Mean ± σ	57.4 ± 19.3	60.9 ± 18.1	59.1 ± 18.7
Median (min; max)	56 (19; 91)	64 (22; 95)	58 (19; 95)
Sex, n (%)				> 0.9992
Female	33 (64.7)	33 (64.7)	66 (64.7)
Male	18 (35.3)	18 (35.3)	36 (35.3)
AST				0.680
Mean ± σ	116.3 ± 143.4	124.3 ± 168.3	120.1 ± 155.1
Median (min; max)	44 (8; 691)	60 (13; 762)	50 (8; 762)
ALT				0.873
Mean ± σ	163.6 ± 191.6	154.1 ± 169.3	159 ± 180.4
Median (min; max)	83 (9; 776)	104 (11; 662)	90 (9; 776)
AP				0.585
Mean ± σ	267.8 ± 329.7	301.9 ± 320.4	284.3 ± 323.9
Median (min; max)	153.5 (8; 1567)	173 (32; 1320)	162 (8; 1567)
GGT				0.821
Mean ± σ	532 ± 454.3	543.4 ± 578.2	537.5 ± 515.1
Median (min; max)	466.5 (39; 1684)	284 (11; 2269)	382 (11; 2269)
Total bilirubin				0.994
Mean ± σ	4.1 ± 4.9	5.3 ± 7.5	4.7 ± 6.3
Median (min; max)	2 (0.1; 23.4)	2.1 (0.2; 29.2)	2.1 (0.1; 29.2)
Direct bilirubin				0.683
Mean ± σ	3.6 ± 4.4	4.2 ± 6.3	3.9 ± 5.4
Median (min; max)	1.6 (0.1; 20.9)	1.1 (0.1; 22.4)	1.5 (0.1; 22.4)

¹Student’s t-test;

²Chi-square test, Mann-Whitney test. AST: Aspartate transaminase; ALT: Alanine transaminase; AP: Alkaline phosphatase; GGT: Gamma-glutamyl transpeptidase; σ: Standard deviation.

Table 2 Endoscopic retrograde cholangiopancreatography findings and complications n (%)

Variable	Group I, n = 51	Group II, n = 51	Total, n = 102	P value
Choledocolithiasis				0.048
No	10 (19.6)	19 (37.3)	29 (28.4)
Yes	41 (80.4)	32 (62.7)	73 (71.6)
Intrahepatic dilatation				0.6572
No	36 (70.6)	38 (74.5)	74 (72.6)
Yes	15 (29.4)	13 (25.5)	28 (27.4)
Extrahepatic dilatation				0.5512
No	25 (49.02)	22 (43.1)	47 (46.1)
Pancreatitis	2 (3.9)	1 (1.9))	3 (2.9)	11
Yes	26 (50.98)	29 (56.9)	55 (53.9)
Pancreatitis	3	0	3 (2.9)	0.09911
Intra- or peridiverticular papilla				0.046
No	43 (84.3)	49 (96.1)	92 (90.2)
Yes	8 (15.7)	2 (3.9)	10 (9.8)
Prosthesis				0.236
No	42 (82.4)	37 (72.6)	79 (77.5)
Yes	9 (17.6)	14 (27.4)	23 (22.5)
Biliary prosthesis				0.463
No	42 (82.4)	39 (76.5)	81(79.4)
Yes	9 (17.6)	12 (23.5)	21 (20.6)
Cholangitis				0.6781
No	49 (96.1)	47 (92.2)	96 (94.1)
Yes	2 (3.9)	4 (7.9)	6 (5.9)
Biliary access
No	12 (23.5)	0		0.00021
Yes	39 (76.5)	51 (100)
Complications,pancreatitis, bleeding or perforation				0.05371
No	44 (86.3)	50 (98)	94 (92.2)
Yes	7 (13.7)	1 (2)	8 (7.8)
Pancreatitis	5	1
Perforation	2	1
Bleeding	0	0

Data are presented as n (%).

¹Fisher’s exact test; Chi-square test.

Table 3 Endoscopic retrograde cholangiopancreatography findings and complications according to group and subgroup

Variable	Groups			Total, n = 102	P value
	Group I, n = 51		Group II, n = 51
	GWC, n = 39	Difficult cannulation, n = 12
Complications, pancreatitis, bleeding or perforation					0.062
No	34 (87.2)	10 (83.3)	50 (98)	94 (92.2)
Yes	5 (12.8)	2 (16.7)	1 (2)	8 (7.8)
Number of cannulations					< 0.0011
Mean ± σ	3.3 ± 1.9	7.5 ± 2.8		4.3 ± 2.8
Median (min.; max.)	3 (1; 10)	8.5 (3; 10)		3 (1; 10)

¹Mann-Whitney test, Likelihood ratio test. GWC: Guidewire cannulation; σ: Standard deviation.

Table 4 Lipase, amylase and C-reactive protein measurements at the different evaluation times

Variable	Group I, n = 51			Group II, n = 51			P value	P valuefor time	P value forinteraction
	Pre	12 h	24 h	Pre	12 h	24 h
Lipase							0.006	< 0.001	0.026
mean ± 	69.4 ± 102.1	439.0 ± 1064.8	199.5 ± 528.3	41.4 ± 37.2	100.6 ± 183.3	85.2 ± 189.1
median (min; max)	38 (9; 611)	52 (10; 5014)	48 (8; 3000)	32 (0; 239)	42.5 (8; 968)	40 (5; 1334)
Amylase							0.003	< 0.001	0.013
mean ± 	76.4 ± 57.8	453.5 ± 1287.4	304.0 ± 979.3	59.6 ± 36.2	98.1 ± 94.3	85.8 ± 102.6
median (min; max)	59 (12; 310)	80 (14; 7900)	70 (13; 6721)	50 (14; 236)	69 (21; 624)	67.5 (12; 732)
C-reactive protein							0.189	0.070	0.353
mean ± 	126.6 ± 539.7	49.5 ± 89.7	45.4 ± 70.5	58.6 ± 104.8	41.4 ± 62.0	38.8 ± 52.9
median (min; max)	11.1 (0.1; 3813)	15.5 (0.3; 486.1)	19.16 (0.5; 340.9)	12 (0.2; 549)	13.8 (0.3; 271)	16.6 (0.5; 223.1)

GEE with gamma distribution and identity link function. Not all patients were evaluated at all times. GEE: Generalized estimating equations; : Standard deviation.