Is endoscopic papillary large balloon dilatation without endoscopic sphincterotomy effective?

Table 1 Baseline characteristics of patients (n = 41) n (%)

Age (yr)	77.7 ± 10.8
Gender ratio (M:F)	19:22
Periampullary diverticulum	28 (68.3)
Previous gastric surgery	3 (7.3)
Billroth II/Roux-en-Y reconstruction, n	2/1
Previous cholecystectomy	12 (29.2)
Gallbladder stone	18 (43.9)
Anticoagulant or antiplatelet therapy	19 (46.3)
Diabetes mellitus	3 (7.3)
CBD diameter (distal/maximum) (mm)	13.5 ± 2.4/16.4 ± 3.1
CBD stone diameter (maximum transverse) (mm)	13.4 ± 3.4
Number of stones	3.0 ± 2.4

CBD: Common bile duct; M: Male; F: Female.

Table 2 Outcome of endoscopic papillary large balloon dilation (n = 41) n (%)

Balloon size
10-12 mm/12-15 mm/15-18 mm/18-20 mm	10/20/8/3
Distal CBD (balloon diameter)/CBD stone ratio	1.03 ± 0.15
Maximum CBD/CBD stone ratio	1.25 ± 0.19
Waist disappearance	30/41 (73.1)
Procedure time (min)	44.5 ± 21.2
Complete stone removal	40/41 (97.5)
Sessions required for complete stone removal	1.2 ± 0.62
Application of ML	5/41 (12.2)
Amylase after EPLBD (IU/L)	427 ± 695

CBD: Common bile duct; ML: Mechanical lithotripsy.

Table 3 Early adverse events of endoscopic papillary large balloon dilation (n = 41) n (%)

Early (< 72 h)
Asymptomatic hyperamylasemia	2/41 (4.9)
Acute pancreatitis	2/41 (4.9)
Mild/moderate/severe	2/0/0
Bleeding	0/41 (0)
Acute cholangitis	0/41 (0)
Perforation	1/41 (2.4)

Table 4 Waist disappearance vs waist non-disappearance

Variables	Waist disappearance(n = 30)	Waist non-disappearance(n = 11)	P value
Age (yr)	77.7 ± 10.8	77.5 ± 11.4	NS
Gender (M:F)	15:15	4:7	NS
Periampullary diverticulum	70% (21/30)	63.6% (7/11)	NS
Distal CBD diameter (mm)	13.0 ± 2.1	14.8 ± 2.9	NS
Distal CBD diameter/stone ratio	1.05 ± 0.13	1.00 ± 0.21	NS
Number of stones	2.8 ± 2.2	3.6 ± 2.7	NS
Procedure time (min)	43 ± 20	49 ± 24	NS
Sessions required for complete stone clearance	1.1 ± 0.86	1.3 ± 0.43	NS
Application of ML	13.3% (4/30)	9.1% (1/11)	NS
Acute pancreatitis	3.3% (1/30)	9.1% (1/11)	NS

NS: Not significant; CBD: Common bile duct; ML: Mechanical lithotripsy.

Table 5 Summary of published series of endoscopic papillary large-balloon dilatation for the removal of common bile duct stones n (%)

Ref.	Design	No. of cases	CBD stone diameter (mm)	Degree of EST	Balloon size (mm)	Complete stone removal overall, n (%)	Complete stone romoval initial, n (%)	No. sessions, mean	Application of ML, n (%)	PEP,n (%)	Bleeding,n (%)	Cholangitis, n (%)	Perforation, n (%)
Ersoz et al[8], 2003	Retrospective	58	16/18, mean	Moderate	12-20, range	58/58 (100)	48/58 (82.8)	1.2	4/58 (6.9)	2/58 (3.4)	3/58 (5.2)	2/58 (3.4)	0/58 (0)
Maydeo et al[9], 2007	Prospective	60	16, mean	Large	12-15, mean	60/60 (100)	57/60 (95)	1.0	3/60 (5)	0/60 (0)	1/60 (1.7)	0/60 (0)	0/60 (0)
Heo et al[10], 2007	Randmized controlled trial	100	16, mean	Moderate	12-20, range	97/100 (97)	83/100 (83)	1.1	8/100 (8)	4/100 (4)	0/100 (0)	0/100 (0)	0/100 (0)
Minami et al[11], 2007	Retrospective	88	14, mean	Small	12-20, range	87/88 (98.9)	87/88 (98.9)	1.0	1/88 (1.1)	1/88 (1.1)	1/88 (1.1)	1/88 (1.1)	0/88 (0)
Misra et al[13], 2008	Retrospective	50	15-25, range	Adequate	12-20, range	NA	NA	NA	5/50 (10)	4/50 (8)	2/50 (4)	0/50 (0)	0/50 (0)
Attasaranya et al[14], 2008	Retrospective	103	13, median	Discretion of endoscopist	13.5, median	102/107 (95.1)	102/107 (95.1)	1.0	28/103 (27.2)	0/103 (0)	2/103 (1.9)	0/103 (0)	1/103 (1)
Itoi et al[15], 2009	Retrospective	53	14.8, mean	Moderate	12-20, range	53/53 (100)	51/53 (96.2)	1	3/53 (5.7)	1/53 (1.9)	0/53 (0)	1/53 (1.9)	0/53 (0)
Jeong et al[16], 2009	Retrospective	38	17.7, mean	Not performed	15-18, range	37/38 (97.4)	25/37 (65.8)	NA	8/38 (21.1)	1/38 (2.6)	0/38 (0)	0/38 (0)	0/38 (0)
Draganov et al[17], 2009	Retrospective	44	12.7, mean	Large	10-15, range	42/44 (95)	37/44 (84)	1.1	2/44 (4.5)	0/44 (0)	2/44 (4.5)	1/44 (2.2)	0/44 (0)
Kim et al[18], 2009	Randmized controlled trial	27	20.8, mean	Small	15-18, range	27/27 (100)	23/27 (85.2)	1.3	9/27 (33.3)	0/27 (0)	0/27 (0)	0/27 (0)	0/27 (0)
Stefanidis et al[22], 2011	Randmized controlled trial	45	12-20, range	Large	12-20, range	44/45 (97.8)	44/45 (97.8)	1.0	0/45 (0)	1/45 (2.2)	1/45 (2.2)	0/45 (0)	0/45 (0)
Chan et al[23], 2011	Retrospective	247	16.4, mean	Not performed	11-20, range	229/247 (92.7)	202/247 (81.8)	1.2	39/247 (15.8)	2/247 (0.8)	6/247 (2.4)	1/247 (0.4)	0/247 (0)
Kim et al[24], 2011	Retrospective	72	17.5, mean	Small	12-20, range	70/72 (97.2)	63/72 (87.5)	1.1	6/72 (8.3)	5/72 (6.9)	1/72 (1.3)	0/72 (0)	0/72 (0)
Jang et al[25], 2013	Retrospective	40	10.5, median	Not performed	10-17, range	40/40 (100)	37/40 (92.5)	1.1	1/40 (2.5)	2/40 (5.0)	0/40 (0)	0/40 (0)	0/40 (0)
Kogure et al[26], 2014	Retrospective	28	14, mean	Not performed	12-18, range	27/28 (96)	25/28 (89)	1.1	3/28 (11)	1/28 (4)	0/28 (0)	0/28 (0)	1/28 (4)
Present study	Prospective	41	13.4 mean	Not performed	11-20, range	40/41 (97.5)	36/41 (87.8)	1.2	5/41 (12.2)	2/41 (4.9)	0/41 (0)	0/41 (0)	1/41 (2.4)

Results are described as large balloon biliary sphinteroplasty alone. NA: Not available; CBD: Common bile duct; ML: Mechanical lithotripsy; PEP: Post-retrograde cholangiopancreatography pancreatitis.