Endoscopic sphincterotomy plus large-balloon dilation vs endoscopic sphincterotomy for choledocholithiasis: A meta-analysis

Table 1 Characteristics of the included randomized controlled trials (according to the Cochrane Collaboration’s tool for assessing risk of bias)

Ref.	Sequence generation	Allocation concealment	Blinding of participants	Incomplete outcome	Selective outcome	Other sources of bias
Heo et al[22] 2007	Computer random number generator	Sealed envelope	Outcome assessment blinded	No missingoutcome data	All prespecifiedoutcomes reported	No
Hong et al[11] 2009	Unclear	Not reported	Unclear	No missingoutcome data	All prespecifiedoutcomes reported	No
Kim et al[23] 2009	The order of the procedure	Not reported	Unclear	No missingoutcome data	All prespecifiedoutcomes reported	No
Kim et al[12] 2009	Unclear	Not reported	Unclear	No missingoutcome data	All prespecifiedoutcomes reported	No
Stefanidis et al[24] 2011	Random number table	Sealed envelope	Outcome assessment blinded	No missingoutcome data	All prespecifiedoutcomes reported	No
Teoh et al[13] 2013	Computer random number generator	Sealed envelope	Outcome assessment blinded	No missingoutcome data	All prespecifiedoutcomes reported	No

Table 2 Characteristics of the included randomized controlled trials

Ref.	Format	Country	Center involved	EST plus LBD, EST				Balloon diameter (mm)	Jadad score
				Number (n)	Male, female	Mean age (yr)	Stone size (mm)
Heo et al[22] 2007	Full text	Korea	1	100	48, 52	64	16.0 ± 0.71	12-20	4
				100	50, 50	63	15.0 ± 0.71
Hong et al[11] 2009	Abstract	Korea	1	70	Not reported	Not reported	> 15	15 or 20	1
				65			> 15
Kim et al[23] 2009	Full text	Korea	1	27	12, 15	70	15-38.3	15, 16.5 or 18	3
				28	14, 14	70	15-48
Kim et al[12] 2009	Abstract	Korea	1	104	53, 51	70	> 10	12-20	1
				100	49, 51	69	> 10
Stefanidis et al[24] 2011	Full text	Greece	1	45	24, 21	69	12-20	15, 18 or 20	4
				45	22, 23	68	12-20
Teoh et al[13] 2013	Full text	Hong Kong	2	73	32, 41	72	≥ 13	13-15	4
				78	40, 38	73	≥ 13

¹Values are mean ± SD. EST: Endoscopic sphincterotomy; LBD: Large-balloon dilation.

Table 3 Outcome data derived from the included randomized controlled trials n (%)

Ref.	Intervention	Complete stone removal	Stone removal inthe first session	Mechanical lithotripsy	Overall complications	Pancreatitis	Bleeding	Infection of biliary tract	Perforation
Heo et al[22] 2007	Small EST plus LBD	97/100 (97)	83/100 (83)	8/100 (8)	5/100 (5)	4/100 (4)	0/100 (0)	1/100 (1)	0/100 (0)
	Full EST	98/100 (98)	87/100 (87)	9/100 (9)	7/100 (7)	4/100 (4)	2/100 (2)	1/100 (1)	0/100 (0)
Hong et al[11] 2009	Small EST plus LBD	70/70 (100)	Not reported	13/70 (19)	8/70 (11)	4/70 (6)	4/70 (6)	0/70 (0)	0/70 (0)
	Conventional EST	65/65 (100)		47/65 (72)	19/65 (29)	9/65 (14)	10/65 (15)	0/65 (0)	0/65 (0)
Kim et al[23] 2009	Small EST plus LBD	27/27 (100)	23/27 (85)	9/27 (33)	0/27 (0)	0/27 (0)	0/27 (0)	0/27 (0)	0/27 (0)
	Conventional EST	28/28 (100)	23/28 (82)	9/28 (32)	0/28 (0)	0/28 (0)	0/28 (0)	0/28 (0)	0/28 (0)
Kim et al[12] 2009	Small EST plus LBD	100/104 (96)	89/104 (86)	8/104 (8)	11/104 (11)	10/104 (10)	1/104 (1)	0/104 (0)	0/104 (0)
	Conventional EST	92/100 (92)	82/100 (82)	17/100 (17)	10/100 (10)	9/100 (9)	0/100 (0)	0/100 (0)	1/100 (1)
Stefanidis et al[24] 2011	Full EST plus LBD	44/45 (98)	Not reported	0/45 (0)	2/45 (4)	1/45 (2)	1/45 (2)	0/45 (0)	0/45 (0)
	Full EST plus ML	41/45 (91)		45/45 (100)	9/45 (20)	1/45 (2)	1/45 (2)	6/45 (13)	1/45 (2)
Teoh et al[13] 2013	Small EST plus LBD	71/73 (97)	65/73 (89)	21/73 (29)	5/73 (7)	2/73 (3)	1/73 (1)	2/73 (3)	0/73 (0)
	Full EST	78/78 (100)	69/78 (88)	36/78 (46)	8/78 (10)	3/78 (4)	0/78 (0)	3/78 (4)	2/78 (3)

EST: Endoscopic sphincterotomy; LBD: Large-balloon dilation.

Table 4 Analyses of procedure-related complications n (%)

Complications	All 6 studies					Four full-text studies (high-quality)
	Incidence EST plus LBD, EST	OR/Peto OR (95%CI)	Pvalue	Heterogeneity		Incidence EST plus LBD, EST	OR/Peto OR (95%CI)	Pvalue	Heterogeneity
				I2	Pvalue				I2	Pvalue
Overall	31/419 (7.4)	0.53 (0.33-0.85)	0.008	28%	0.24	12/245 (4.9)	0.48 (0.24-0.99)	0.05	0%	0.37
	53/416 (12.7)					24/251 (9.6)
Pancreatitis	21/419 (5.0)	0.77 (0.43-1.39)	0.39	0%	0.74	7/245 (2.9)	0.89 (0.32-2.49)	0.83	0%	0.95
	26/416 (6.3)					8/251 (3.2)
Bleeding	7/419 (1.7)	0.50 (0.20-1.23)	0.13	22%	0.27	2/245 (0.8)	0.68 (0.12-3.93)	0.66	31%	0.24
	13/416 (3.1)					3/251 (1.2)
Infection of biliary tract	3/419 (0.7)	0.34 (0.11-1.02)	0.05	28%	0.25	3/245 (1.2)	0.34 (0.11-1.02)	0.05	28%	0.25
	10/416 (2.4)					10/251 (4.0)
Perforation	0/419 (0.0)	0.14 (0.02-0.98)	0.05	0%	1.00	0/245 (0.0)	0.14 (0.01-1.35)	0.09	0%	0.98
	4/416 (1.0)					3/251 (1.2)

EST: Endoscopic sphincterotomy; LBD: Large-balloon dilation.