Pancreatic stent improves the success rate of needle-knife papillotomy in patients with difficult biliary cannulation

Table 1 Clinical and endoscopic characteristics of the pancreatic stent- needle-knife papillotomy and Freehand- needle-knife papillotomy groups, n (%)

	Total (n = 190)	PS-NKP group (n = 82)	FH-NKP group (n = 108)	P value
Age, years (range)	66.5 (26-97)	65.17 (28-92)	67.46 (26-97)	0.406
Male	110 (57.9)	52 (63.4)	58 (53.7)	0.179
Indications for ERCP
Choledocholithiasis	115 (60.5)	50 (61.0)	65 (60.2)	0.912
Malignant biliary stricture	60 (31.6)	25 (30.5)	35 (32.4)	0.778
Distal biliary malignancy	49 (25.8)	19 (23.2)	30 (27.8)	0.509
Benign biliary stricture	11 (5.8)	6 (7.3)	5 (4.6)	0.432
Bile leak	7 (3.7)	3 (3.7)	4 (3.7)	0.987
CBD diameter, cm (range)	0.89 (0.3-2.0)	0.86 (0.3-1.9)	0.91 (0.3-2)	0.29
Major papilla status
PAD	44 (23.2)	24 (29.3)	20 (18.5)	0.082
Enlarged/swelling	30 (15.8)	11 (13.4)	19 (17.6)	0.434
Impacted stone	19 (10)	5 (6.1)	14 (13.0)	0.118
Tumor	5 (2.6)	1 (1.2)	4 (3.7)	0.289
Low-set papilla	6 (3.2)	4 (4.9)	2 (1.9)	0.237
Surgically altered anatomy	4 (2.1)	1 (1.2)	3 (2.8)	0.459

PS: Pancreatic stent; NKP: Needle-knife papillotomy; FH: Freehand; ERCP: Endoscopic retrograde cholangiopancreatography; CBD: Common bile duct; PAD: Periampullary diverticulum.

Table 2 Technique factors and adverse events of the Pancreatic stent- needle-knife papillotomy and Freehand- needle-knife papillotomy groups, n (%)

	Total (n = 190)	PS-NKP group (n = 82)	FH-NKP group (n = 108)	P value
Endoscopists
A	39 (20.5)	13 (15.9)	26 (24.1)	0.165
B	54 (28.4)	25 (30.5)	29 (26.9)	0.582
C	55 (28.9)	26 (31.7)	29 (26.9)	0.465
D	22 (11.6)	9 (11.0)	13 (12.0)	0.821
E	10 (5.3)	6 (7.3)	4 (3.7)	0.269
F	10 (5.3)	3 (3.7)	7 (6.5)	0.388
Significant bleeding during NKP	11 (5.8)	2 (2.4)	9 (8.3)	0.085
Successful NKP	167 (87.9)	77 (93.9)	90 (83.3)	0.027
Adverse events
Overall	18 (9.5)	6 (7.3)	12 (11.1)	0.493
Perforation	2 (1.1)	1 (1.2)	1 (0.9)	0.844
Pancreatitis	5 (2.6)	2 (2.4)	3 (2.8)	0.885
Delayed bleeding	5 (2.6)	1 (1.2)	4 (3.7)	0.289
Cholangitis	6 (3.2)	2 (2.4)	4 (3.7)	0.621

PS: Pancreatic stent; NKP: Needle-knife papillotomy; FH: Freehand.

Table 3 Subgroup analysis for patients with periampullary diverticulum, surgically altered anatomy, and significant bleeding during needle-knife papillotomy, n (%)

	Total	PS-NKP group	FH-NKP group	P value
Patients with periampullary diverticulum	(n = 44)	(n = 24)	(n = 20)
NKP success	34 (77.3)	21 (87.5)	13 (65)	0.076
NKP failure	10 (22.7)	3 (12.5)	7 (35)
Patients with surgically altered anatomy	(n = 4)	(n = 1)	(n = 3)
NKP success	2 (50)	1 (100)	1 (33.3)	NP
NKP failure	2 (50)	0	2 (66.7)
Patients with significant bleeding during NKP	(n = 11)	(n = 2)	(n = 9)
NKP success	6 (54.5)	1 (50)	1 (20.0)	0.887
NKP failure	5 (45.5)	1 (50)	4 (80.0)

NKP: Needle-knife papillotomy; PS: Pancreatic stent; FH: Freehand; NP: Not performed.

Table 4 Univariate and multivariate analyses of the factors associated with the results of needle-knife papillotomy

Variables	Univariate analysis		Multivariate analysis
	OR (95%CI)	P value	OR (95%CI)	P value
Age
> 70	0.988 (0.960-1.017)	0.408
≤ 70	Reference
Sex
Female	0.938 (0.389-2.261)	0.887
Male	Reference
Choledocholithiasis
Yes	1.256 (0.505-3.128)	0.642
No	Reference
Malignant biliary stricture
Yes	0.941 (0.365-2.424)	0.9
No	Reference
Benign biliary stricture
Yes	0.714 (0.087-5.848)	0.753
No	Reference
CBD diameter
≤ 6 mm	1.018 (0.914-1.134)	0.745
> 6 mm	Reference
Periampullary diverticulum
Yes	3.009 (1.216-7.448)	0.017	4.235 (1.541-11.637)	0.005
No	Reference		Reference
Impacted stone in the ampulla of Vater
Yes	0.840 (0.181-3.899)	0.824
No	Reference
Surgically altered anatomy
Yes	7.857 (1.051-58.75)	0.045	9.111 (0.942-88.120)	0.056
No	Reference
Endoscopists
D + E	1.914 (0.690-5.310)	0.212
B + C	1.179 (0.483-2.876)	0.717
A	Reference
Significant bleeding during NKP
Yes	7.454 (2.066-26.886)	0.002	5.022 (1.280–19.707)	0.021
No	Reference		Reference
PS before NKP
Yes	0.325 (0.115-0.915)	0.033	0.284 (0.092–0.871)	0.028
No	Reference		Reference

NKP: Needle-knife papillotomy; OR: Odds ratio; CI: Confidence interval; CBD: Common bile duct; PS: Pancreatic stent.