External use of mirabilite to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in children: A multicenter randomized controlled trial

Table 1 Baseline and procedure characteristics of patients in each group

	External use of mirabilite group (n = 117)	Blank group (n = 117)	P value
Female, n (%)	71 (60.7)	60 (51.3)	0.147
BMI, kg/m2 (IQR)	15.59 (14.12, 17.27)	15.55 (14.37, 17.64)	0.359
Age, yr (IQR)	6.8 (4.1, 11.8)	7 (4.0, 7.0)	0.971
Medical history, n (%)			0.609
Idiopathic pancreatitis	58 (49.6)	62 (53.0)
Pancreas divisum	20 (17.1)	24 (20.5)
Pancreaticobiliary maljunction	36 (30.8)	27 (23.1)
Pancreas divisum accompanied annular pancreas	3 (2.6)	4 (3.4)
Procedure, n (%)
EPS (major papilla)	25 (21.4)	20 (17.1)	0.407
EPS (minor papilla)	6 (5.1)	5 (4.3)	0.757
EST	9 (7.7)	16 (13.7)	0.139
ERPD	57 (48.7)	57 (48.7)	1.000
ERBD	30 (25.6)	34 (29.1)	0.557
ENPD	15 (12.8)	15 (12.8)	1.000
ENBD	10 (8.5)	8 (6.8)	0.624
Contrast medium			0.866
Contrast agent dose < 5 mL	96 (82.1)	95 (81.2)
Contrast agent dose ≥ 5 mL	21 (17.9)	22 (18.8)
Attempts for successful Cannulation (≥ 5 times)	20 (17.1)	20 (17.1)	1.000
Pancreatogram	103 (88.0)	104 (88.9)	0.838

EPS: Endoscopic pancreatic sphincterotomy; EST: Endoscopic sphincterotomy; ERPD: Endoscopic retrograde pancreatic drainage; ERBD: Endoscopic retrograde biliary drainage; ENPD: Endoscopic naso-pancreatic drainage; ENBD: Endoscopic naso-biliary drainage.

Table 2 Incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis in each group

	External use of mirabilite group (n = 117)	Blank group (n = 117)	P value
Overall			< 0.0011
PEP	9 (7.7%)	31 (26.5%)
No PEP	108 (92.3%)	86 (73.5%)
< 6 years old			0.0011
PEP	1 (2.1%)	14 (27.5%)
No PEP	46 (97.9%)	37 (72.5%)
≥ 6 years old			0.0311
PEP	8 (11.4%)	17 (25.8%)
No PEP	62 (84.7%)	49 (74.2%)

¹Statistically significant.

PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.

Table 3 Prevalence and severity of ost-endoscopic retrograde cholangiopancreatography pancreatitis in each group

	External use of mirabilite group (n = 9)	Blank group (n = 31)	P value
Severity of PEP			0.0231
Mild	9 (100.0%)	16 (51.6%)
Moderate	0 (0.0%)	13 (41.9%)
Severe	0 (0.0%)	2 (6.5%)

¹Statistically significant.

PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis.

Table 4 Visual analog scale score of abdominal pain at 24 h after endoscopic retrograde cholangiopancreatography pancreatitis in each group

Group	VAS score	Z value	P value
External use of mirabilite group	0 (0, 2)	-3.27	0.0011
Blank group	2 (0, 5)

¹Statistically significant.

VAS: Visual analog scale.

Table 5 The levels of serum necrosis factor-alpha and interleukin-10 in each group (MP 25, P75 pg/mL)

		External use of mirabilite group (n = 117)	Blank group (n = 117)	P value
TNF-α	Pre-ERCP 3 h	1.78 (0.00, 3.39)	1.30 (0.00, 4.25)	0.622
	Post-ERCP 24 h	2.42 (1.14, 6.53)	3.41 (1.63, 8.26)	0.0321
	P value	0.0161	< 0.0011
IL-10	Pre-ERCP 3 h	3.56 (1.49, 6.01)	3.49 (1.24, 6.62)	0.992
	Post-ERCP 24 h	4.60 (2.99, 9.40)	3.76 (1.74, 7.86)	0.0111
	P value	< 0.0011	0.282

¹Statistically significant.

TNF-α: Necrosis factor-alpha; IL-10: Interleukin-10; ERCP: Endoscopic retrograde cholangiopancreatography pancreatitis.

Table 6 The levels of serum D-lactate, endotoxin and diamine oxidase in each group (MP 25, P75 ug/L)

		External use of mirabilite group (n = 117)	Blank group (n = 117)	P value
D-lactate	Pre-ERCP 3 h	190.65 (164.37, 273.58)	224.38 (187.29, 313.58)	0.120
	Post-ERCP 24 h	199.73 (180.57, 233.96)	213.88 (192.04, 314.86)	0.078
	P value	0.849	0.914
Endotoxin	Pre-ERCP 3 h	5.95 (4.06, 7.83)	5.21 (3.94, 6.91)	0.375
	Post-ERCP 24 h	5.36 (4.09, 8.01)	5.35 (4.50, 7.89)	0.874
	P value	0.762	0.559
DAO	Pre-ERCP 3 h	0.65 (0.44, 2.47)	0.63 (0.51, 0.97)	0.635
	Post-ERCP 24 h	1.04 (0.52, 2.47)	0.79 (0.585, 0.79)	0.536
	P value	0.410	0.129

DAO: Diamine oxidase; ERCP: Endoscopic retrograde cholangiopancreatography pancreatitis.