Endoscopic papillary large balloon dilation vs endoscopic sphincterotomy for retrieval of common bile duct stones: A meta-analysis

Table 1 Baseline characteristics of the included studies

Ref.	Sex (male/female)		Intervention	Mean diameter of stones (mm)		Mean number of CBD stones		Balloon size (mm) in EPLBD	Extent of sphincterotomy in EPLBD
	Group 1	Group 2		Group 1	Group 2	Group 1	Group 2
Qian et al[25], 2013	32/31	36/33	Group 1 small EST plus EPLBD (n = 63)	20.6 ± 5.4	20.3 ± 5.3	2.2 ± 1.2	2.3 ± 1.3	12-20	Limited to one-third that in the minor EST group
			Group 2 conventional EST (n = 69)
Teoh et al[26], 2012	32/41	40/38	Group 1 limited EST plus EPLBD (n = 73)	12.47	13.26	≥ 1	≥ 1	≤ 15	One third to one half of the size of papilla
			Group 2 complete EST (n = 78)
Oh et al[16], 2012	20/20	23/20	Group 1 EPLBD alone (n = 40)	13.2 ± 3.6	13.1 ± 3.9	NA	NA	10-18	No precut
			Group 2 EST (n = 43)
Kim et al[15], 2009	NA	NA	Group 1 small EST plus ELPBD (n = 27)	20.8 ± 4.1	21.3 ± 5.2	2.2 ± 1.3	2.3 ± 1.2	15-18	Mid-portion of papilla
			Group 2 EST alone (n = 28)
Heo et al[14], 2007	48/52	50/50	Group 1 EST plus EPLBD (n = 100)	16.0 ± 0.7	15.0 ± 0.7	2.7 ± 2.7	2.2 ± 1.9	12-20	A third of the size of EST group
			Group 2 EST alone (n = 100)

EPLBD: Endoscopic papillary large balloon dilation; EST: Endoscopic sphincterotomy; CBD: Common bile duct; NA: Not available.

Table 2 Quality assessment of the included articles based on the Jadad score

Ref.	Jadad score of RCTs			Article type	Score
	Randomization	Blindness	Withdrawal
Qian et al[25], 2013	Appropriate	NA	Clear	Full text	3
Teoh et al[26], 2012	Appropriate	Double	Clear	Full text	5
Oh et al[16], 2012	Appropriate	Single	Clear	Full text	4
Kim et al[15], 2009	Appropriate	NA	Clear	Full text	3
Heo et al[14], 2007	Appropriate	NA	Clear	Full text	3

RCT: Randomized controlled trial.

Table 3 Pooled effects of efficacy and safety in randomized controlled trials n (%)

Items	Incidence of		Number of subjects	Hetero-geneity I2 (P)	Analysis model	Test for overall effect		RR/Peto OR (95%CI)
	EPLBD	EST				Z	P value
	(n = 303)	(n = 318)
Complete stone removal rate	93.7 (284)	92.5 (294)	621	0% (0.82)	Fixed	0.61	0.54	RR = 1.01
					(M-H)			(0.97-1.06)
Complete ductal clearance in one session	82.2 (249)	77.7 (247)	621	44% (0.13)	Fixed	1.36	0.17	RR = 1.06
					(M-H)			(0.98-1.14)
Requirement for EML	15.5 (47)	25.2 (80)	621	10% (0.35)	Fixed	2.98	0.003a	RR = 0.62
					(M-H)			(0.45-0.85)
Overall Adverse events	7.9 (24)	10.7 (34)	621	0% (0.97)	Fixed	1.16	0.25	RR = 0.75
					(M-H)			(0.46-1.22)
Post-ERCP pancreatitis	4.0 (12)	5.0 (16)	621	0% (0.98)	Peto	0.62	0.54	Peto OR = 0.79
								(0.37-1.68)
Hemorrhage	1.7 (5)	2.8 (9)	621	28% (0.25)	Peto	1.00	0.32	Peto OR = 0.57
								(0.19-1.71)
Perforation	0.3 (1)	0.9 (3)	621	34% (0.22)	Peto	0.93	0.35	Peto OR = 0.39
								(0.06-2.81)
Acute cholangitis	1.3 (4)	1.3 (4)	621	0% (0.71)	Peto	0.11	0.92	Peto OR = 1.08
								(0.27-4.37)

^aSignificant difference. EML: Endoscopic mechanical lithotripsy; ERCP: Endoscopic retrograde cholangiopancreatography; Fix: Fixed effects model; M-H: Mantel-Haenszel.

Table 4 Sensitivity analysis of primary pooled outcome in the randomized controlled trials

Items	Adjusted pooled outcome of RCTs with article excluded
	Heterogeneity I2 (P)	P value	RR or Peto OR (95%CI)
Complete stone removal rate	0% (0.70)	0.63	1.01 (0.97-1.06)
Complete ductal clearance in one session	58% (0.07)	0.37	1.06 (0.93-1.22)
Requirement of EML	27% (0.25)	0.007a	0.64 (0. 46-0.89)
Overall adverse events	0% (1.00)	0.24	0.69 (0.37-1.29)
Post-ERCP pancreatitis	0% (0.93)	0.61	0.80 (0.35-1.86)
hemorrhage	35% (0.22)	0.68	0.69 (0.12-4.01)
perforation	0% (0.99)	0.09	0.14 (0.01-1.40)
Acute cholangitis	0% (0.70)	0.72	0.72 (0.12-4.20)

^aSignificant difference (P < 0.05). RCT: Randomized controlled trial; EML: Endoscopic mechanical lithotripsy; ERCP: Endoscopic retrograde cholangiopancreatography.