Primary needle-knife fistulotomy for preventing post-endoscopic retrograde cholangiopancreatography pancreatitis: Importance of the endoscopist’s expertise level

Table 1 Baseline characteristics between the experienced and less experienced endoscopists

	Total, n = 542, (%)	Experienced, n = 237, (%)	Less-experienced, n = 305, (%)	P value
Age (yr)	67.8 ± 13.4	66.6 ± 14.2	68.7 ± 12.6	0.070
Male (%)	307 (56.6)	129 (54.4)	178 (58.4)	0.361
Periampullary diverticulum	163 (30.1)	81 (34.2)	82 (26.9)	0.067
Ampulla configurations				0.224
Non-prominent	0 (0)	0 (0)	0 (0)
Prominent	455 (83.9)	205 (86.5)	250 (82.0)
Bulging	65 (12.0)	25 (10.5)	0 (13.1)
Distorted	15 (2.8)	3 (1.3)	12 (3.9)
Hook-nose shape	7 (1.3)	4 (1.7)	3 (1.0)
Malignancy	200 (36.9)	91 (38.4)	109 (35.7)	0.525
Benign diseases	342 (63.1)	146 (61.6)	196 (64.3)

Table 2 Baseline characteristics between the conventional technique with sphincterotomy and needle-knife fistulotomy groups

	Conventional technique with sphincterotomy, n = 375, (%)			Primary NKF less-experienced, n = 167, (%)
	Experienced, n = 147, (%)	Less-experienced, n = 228, (%)	P value	Experienced, n = 90, (%)	Less-experienced, n = 77, (%)	P value
Age (yr)	68.8 ± 12.9	68.7 ± 12.1	0.964	63.1 ± 15.6	68.7 ± 14.3
Male	75 (51.0)	130 (57.0)	0.256	54 (60.0)	48 (62.3)	0.759
Periampullary diverticulum	52 (35.4)	68 (29.8)	0.262	29 (32.2)	14 (18.2)	0.039a
Ampulla configurations			0.625			0.265
Non-prominent	0 (0)	0 (0)		0 (0)	0 (0)
Prominent	136 (92.5)	205 (89.9)		69 (76.7)	54 (70.1)
Bulging	8 (5.4)	19 (8.3)		17 (18.9)	16 (20.8)
Distorted	2 (1.4)	3 (1.3)		1 (1.1)	5 (6.50)
Hook-nose shape	1 (0.7)	1 (0.4)		3 (3.3)	2 (2.6)
Malignancy	58 (39.5)	80 (35.1)	0.393	33 (36.7)	29 (37.7)	0.895
Benign diseases	89 (60.5)	148 (64.9)		57 (63.3)	48 (62.3)

^aP < 0.05.

NKF: Needle-knife fistulotomy.

Table 3 Compared results between the experienced and less-experienced endoscopists in each primary cannulation technique

	Conventional technique with sphincterotomy			NKF
	Experienced (n = 147) (%)	Less-experienced (n = 228) (%)	P value	Experienced (n = 90) (%)	Less-experienced (n = 77) (%)	P value
Success rate	361/375 (96.3)			161/167 (96.4)		0.936
	144/147 (98.0)	217/228 (95.2)	0.166	88/90 (97.8)	73/77 (94.8)	0.306
Cannulation time (min)	4.8 ± 3.5			4.8 ± 3.2		0.951
	5.1 ± 3.5	4.6 ± 3.6	0.200	4.2 ± 3.1	5.5 ± 3.1	0.010a
Total procedure time (min)	17.2 ± 9.2			15.2 ± 8.2		0.019a
	17.6 ± 9.6	16.9 ± 8.9	0.490	14.9 ± 8.4	15.6 ± 8.0	0.598
Post-ERCP pancreatitis	25 (6.7)			4 (2.4)		0.040a
	5 (3.4)	20 (8.9)	0.039a	1 (1.1)	3 (3.9)	0.243
Hyperamylasemia	52 (14.0)			13 (7.8)		0.041a
	15 (10.2)	37 (16.4)	0.090	5 (5.6)	9 (11.7)	0.156
Bleeding	10 (2.7)			6 (3.6)		0.568
	2 (1.4)	8 (3.6)	0.202	2 (2.2)	4 (5.2)	0.306
Perforation	1 (0.3)			0 (0)		0.505
	0 (0)	1 (0.4)	0.423	0 (0)	0 (0)	NA

^aP < 0.05.

NKF: Needle-knife fistulotomy; ERCP: Endoscopic retrograde cholangiopancreatography; NA: Not available.

Table 4 Clinical factors associated with post endoscopic retrograde cholangiopancreatography pancreatitis in conventional technique with sphincterotomy and needle-knife fistulotomy group

	Conventional technique with sphincterotomy						NKF
	Total	With PEP	Without PEP	P value		Odd ratio (95%CI)	Total	With PEP	Without PEP	P value		Odd ratio (95%CI)
	n = 375, (%)	n = 25, (%)	n = 350, (%)	Uni-	Multi-		n = 167, (%)	n = 4, (%)	n = 163, (%)	Uni-	Multi-
Age (yr)	68.7 ± 12.4	65.6 ± 12.5	69.0 ± 12.4	0.194	0.126	0.98(0.94-1.01)	65.7 ± 15.3	69.8 ± 11.9	65.6 ± 15.3	0.593	-
Male (%)	205 (54.7)	12 (48.0)	193 (55.1)	0.490			102 (61.1)	2 (50.0)	100 (61.3)	0.648	-
Periampullary diverticulum	120 (32.0)	8 (32.0)	112 (32.0)	0.999			43 (25.7)	1 (25.0)	42 (25.8)	0.973	-
Malignancy	138 (36.8)	9 (36.0)	129 (36.9)	0.932			62 (37.1)	3 (75.0)	59 (36.2)	0.114	0.165	4.74(0.41-54.8)
Benign diseases	237 (63.2)	16 (64.0)	221 (63.1)	-			105 (62.9)	1 (25.0)	104 (63.8)	-	-
Less-experienced endoscopist	228 (60.8)	20 (80.0)	208 (59.4)	0.044a	0.037a	2.94(1.07-8.10)	77 (46.1)	3 (75.0)	74 (45.4)	0.243	0.110	6.40 (0.45-90.6)
Pancreatic duct stent	72 (19.2)	4 (16.0)	68 (19.4)	0.675			0 (0.0)	0 (0.0)	0 (0.0)	-	-
Cannulation time (min)	4.8 ± 3.5	5.3 ± 3.5	4.7 ± 3.5	0.431			4.8 ± 3.2	8.8 ± 1.7	4.7 ± 3.1	0.010a	0.945	0.99 (0.75-1.31)
Total procedure time (min)	17.2 ± 9.2	21.0 ± 8.8	16.9 ± 9.2	0.031a	0.026a	1.04 (1.01-1.08)	15.2 ± 8.2	30.0 ± 9.3	14.8 ± 7.9	0.000a	0.004a	1.14 (1.04-1.25)

^aP < 0.05.

NKF: Needle-knife fistulotomy; PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis; CI: Confidence interval.