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

doi:10.3748/wjg.v24.i16.1803

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Clinical Trial

World J Gastroenterol. Apr 28, 2018; 24(16): 1803-1811
Published online Apr 28, 2018. doi: 10.3748/wjg.v24.i16.1803

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	Group II, n = 51
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
Variable	Pre	12 h	24 h	Pre	12 h	24 h	P value	P valuefor time	P value forinteraction
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.

Citation: Furuya CK, Sakai P, Marinho FRT, Otoch JP, Cheng S, Prudencio LL, de Moura EGH, Artifon ELA. Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial. World J Gastroenterol 2018; 24(16): 1803-1811
URL: https://www.wjgnet.com/1007-9327/full/v24/i16/1803.htm
DOI: https://dx.doi.org/10.3748/wjg.v24.i16.1803