Combination of two-hour post-endoscopic retrograde cholangiopancreatography amylase levels and cannulation times is useful for predicting post-endoscopic retrograde cholangiopancreatography pancreatitis

Table 1 Patient characteristics

Patients	n
Male, %	846, 60%
Age, median (range)	73 (12-99)
Native papilla	668, 47.6%
Indication
Malignancy	522
Choledocholithiasis	771
Others	110
Cannulation time, median (range)	5 min (1-185)
Procedure time, median	37 min (3-185)
2 h amylase	97 IU/mL (10-3502)
median (range)
ERCP and related procedures
Total ERCP	1403
ENBD	362
EBS	380
EMS	42
EPS	124
Precut	35
EST	505
EPBD	20
EPLBD	38
Pancreatic duct brush	15

ERCP: Endoscopic retrograde cholangiopancreatography; EBS: Endoscopic biliary stent; EMS: Endoscopic metallic stent; EPS: Endoscopic pancreatic stent; EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; EPLBD: Endoscopic papillary large balloon dilation; ENBD: Endoscopic nasobiliary drainage.

Table 2 Complications

Complications	n, % (95%CI)
Bleeding	8, 0.57 (0.28-1.12)
Perforation	5, 0.35 (0.15-0.83)
Pancreatitis (severe pancreatitis)	55, 3.9 (3.02-5.07) [3, 0.2 (0.073-0.64)]
Procedure-related death	0, 0

Table 3 Univariate analysis of pancreatitis predictors

Predictors	Odds ratio	95%CI	P value
Sex (female)	0.53	0.31-0.92	0.0245
Native papilla	5.62	2.73-11.6	< 0.0001
ENBD	0.77	0.43-1.38	0.4313
EBS1	2.62	1.18-5.85	0.0129
EMS	0.37	0.13-1.08	0.0784
EPS	0.47	0.22-1.00	0.0528
Precut	0.23	0.08-0.61	0.0102
EST	0.49	0.28-0.84	0.0099
EPBD	0.22	0.06-0.78	0.0405
EPLBD	-	-	0.3983
Pancreatic duct brush	6.42	1.75-23.5	0.0186
2-h amylase ≥ 2 times ULN	36.6	17.6-76.3	< 0.0001
Cannulation time ≥ 13 min	5.82	3.33-10.2	< 0.0001
Procedure time ≥ 54 min	4.70	2.70-8.18	< 0.0001

¹EBS: Including with and without EST. EBS: Endoscopic biliary stent; EMS: Endoscopic metallic stent; EPS: Endoscopic pancreatic stent; EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; ULN: Upper limit of normal; EPLBD: Endoscopic papillary large balloon dilation; ENBD: Endoscopic nasobiliary drainage.

Table 4 Age-adjusted multivariate analysis of pancreatitis predictors

Predictors	Odds ratio	95%CI	P value
Sex (female)	1.46	0.77-2.75	0.2431
Native papilla	1.78	0.75-4.48	0.1908
Endoscopic biliary stent	0.61	0.23-1.45	0.2810
Precut	1.71	0.43-6.00	0.4288
EST	1.18	0.60-2.35	0.6278
EPBD	1.94	0.34-8.91	0.4296
Pancreatic duct brush	3.15	0.54-15.5	0.1870
2 h amylase ≥ 2 times ULN	25.4	12.2-59.9	< 0.0001
Cannulation time ≥ 13 min	2.63	1.34-5.23	0.0051
Procedure time ≥ 54 min	1.23	0.389-3.67	0.7183

EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; ULN: Upper limit of normal.

Table 5 Previous reports of hourly variations in post-endoscopic retrograde cholangiopancreatography amylase levels

Ref.	Year	n	Time1(h)	Amylasecut off	Sensitivity	Specificity	PPV	NPV	Definition of PEP
LaFerla et al[23]	1986	20	2	800	n.d.	n.d.	n.d.	Unlikely	Amy > 1200
Gottlieb et al[24]	1996	231	2	276	82	76	15	98	Consensus criteria
Testoni et al[25]	1999	409	2	5 ×	23.1	98.2	46.2	94.9	Amy > 5 × ULN
			4	5 ×	53.8	95	42.4	96.8
			8	5 ×	76.9	96.9	62.5	98.4
Testoni et al[26]	2001	1185	6-8	3 ×	n.d.	n.d.	n.d.	100	Pancreatic type pain
Thomas et al[27]	2001	263	4	2 ×	90	92.9	24.3	99.6	Consensus criteria
			4	3 ×	70	95.3	36.8	98.8
Kapetanos et al[28]	2007	97	2	3 ×	72	79	32	95	Consensus criteria
			6	3 ×	82	75	30	97
Ito et al[16]	2007	1291	3	3 ×	77	n.d.	29	n.d.	Amy > 1 × ULN,
			6	3 ×	85	n.d.	24	n.d.	with pain at 24 h
Nishino et al[29]	2009	1631	4	3 ×	89.8	72.9	12.7	99.4	Consensus criteria
			4	4 ×	84.7	80.4	16	99.2
Artifon et al[30]	2010	300	4	1.5 ×	77	63	26	94	Consensus criteria
Sutton et al[15]	2011	959	4	2.5 ×2	80	80.4	11.1	99.2	Consensus criteria
			4	2.5 ×3	100	91.8	4.3	100	(mod/severe only)
Our study	2015	1403	2	2 ×	85.5	85.8	19.8	99.3	Consensus criteria
			2	2 ×4	96.4	68.8	11.2	99.8

¹Hourly variations in serum amylase measurements after the procedure;

²With pancreatogram;

³Without pancreatogram;

⁴Longer cannulation time. Consensus criteria: Amy > 3 × ULN with pain at 24 h. n.d.: Not described; ULN: Upper limit of normal.