Endoscopic papillary large balloon dilatation with sphincterotomy is safe and effective for biliary stone removal independent of timing and size of sphincterotomy

Table 1 Clinical characteristics by common bile duct clearance at the index endoscopic retrograde cholangiopancreatography n (%)

Variables	Group A (n = 166)	Group B (n = 63)	P value
Mean age	68.4 ± 14.3	68.4 ± 14.1	0.93
Sex (M: F)	70:96	17:46	0.046
HTN	65 (39.2)	26 (41.3)	0.88
IHD	19 (11.4)	7 (11.1)	0.87
DM	14 (8.4)	4 (6.3)	0.80
CLD	1 (0.6)	None	0.60
COPD	16 (9.6)	5 (7.9)	0.89
CKD	7 (4.2)	2 (3.2)	0.98

Table 2 Outcome of index endoscopic retrograde cholangiopancreatography by stone characteristics and anatomical features of the biliary tree n (%)

Variables	Group A (n = 166)	Group B (n = 63)	P value
Number of stones	2 (1-13)	3 (1-12)	0.006
Median diameter of stones (mm)	12.4 (4.5-30)	17.4 (10.1-32)	< 0.000001
Median diameter of duct (mm)	12.4 (5-30)	18.3 (9.2-30)	0.001
Ampullary or peri-ampullary diverticulum	37 (22.3)	10 (15.9)	0.370
Intact GB	117 (70.5)	50 (79.4)	0.240
Primary stone disease	118 (71.1)	44 (69.8)	0.980
Recurrent stone disease1	48 (28.9)	19 (30.2)	0.900

¹Recurrent stones were after previous EST.

Table 3 Diameter of the balloon used

Balloon size	n	Percent
10-11 mm	62	27%
12-15 mm	139	61%
16-18 mm	28	12%

Table 4 Procedure characteristics by outcomes of common bile duct stone extraction n (%)

Variables	Group A (n = 166)	Group B (n = 63)	P value
Procedure time (min)	30.5 (9-160)	44 (12-90)	0.0010
Number of ERCP (median)	1 (1-3)	2 (1-10)	0.0001
Pre-cut sphincterotomy	6 (3.6)	2 (3.2)	0.8000
Previous Sphincterotomy	106 (63.9)	42 (66.7)	0.8000
Fresh Sphincterotomy	58 (35.5)	23 (36.5)	0.9800
Median Balloon size diameter	13 (10-18)	13.5 (10-18)	0.2200

Table 5 Adverse events after endoscopic papillary large balloon dilatation n (%)

Variables	Group A (n = 166)	Group B (n = 63)	P value
Pancreatitis	0	2 (3.2)	0.13
Bleeding	2 (1.2)	0	0.93
Cholangitis	None	None	NA
Perforation	None	None	NA
Mortality	None	None	NA