Endoscopic papillary large balloon dilation for the removal of bile duct stones

Table 1 Baseline clinical characteristics of the patients undergoing endoscopic papillary large balloon dilation with endoscopic sphincterotomy n (%)

Ref.	Study design	No. of procedures, No. of patients	Mean age, year	No. of periampullary diverticulum	Mean size of largest stone, mm	Range of stone size, mm	Prior EST	Altered anatomy
Ersoz et al[21]	R	58	NA	4 (6.9)	NA	12-28	14	0
Hwang et al[22]	R	30	71.3	6 (20.0)	21.6	15-35	0	NA
Maydeo et al[23]	P	60	58.0	0 (0.0)	16.0	12-20	0	0
Minami et al[24]	R	88	74.01	NA	14.0	> 12	0	NA
Heo et al[25]	RCT	100	64.4	49 (49.0)	16.0	NA	0	0
Lee et al[26]	R	55	70.8	16 (29.1)	20.8	15.4-35.5	0	B-II:2
Kim et al[27]	R	35	66.9	9 (25.7)	26.1	12-50	14	NA
Lee et al[28]	R	41	72.2	21 (51.2)	18.2	10-45	0	B-II:2, R-Y:2
Misra et al[29]	R	50	40.1	NA	NA	< 15-25	0	NA
Attasaranya et al[30]	R	107, 103	70.1	36 (35.0)	13.01	10-30	50	B-II:6
Espinel et al[31]	P	93	76.5	30 (32.2)	13.4	5-30	42	B-II:4
Itoi et al[32]	R	53	75.3	25 (47.2)	14.8	10-28	0	0
Kim et al[33]	RCT	27	70.3	9 (33.3)	20.8	15-38.3	0	0
Itoi et al[34]	R	18	79.1	9 (50.0)	16.7	13-21	0	B-I:1
Kurita et al[35]	R	24	82.01	18 (75.0)	16.51	12-33	24	NA
Ghazanfar et al[36]	P	84	48.4	NA	14.7	10-32	0	NA
Kim et al[37]	R	70	68.7	24 (34.3)	12.5	5-30	70	NA
Youn et al[38]	R	101	69.1	12 (11.9)	21.8	7-52	0	B-I:2, B-II:3
Kim et al[39]	R	72	69.3	41 (56.9)	NA	> 10	0	0
Stefanidis et al[40]	RCT	45	69.4	NA	NA	12-20	0	0
Rebelo et al[41]	R	30	68.0	7 (23.3)	17.01	12-30	4	NA
Sakai et al[42]	R	59	76.7	27 (45.8)	15.0	10-28	21	B-I:3, B-II:2
Park et al[43]	R	633	72.7	246 (39.1)	15.4	10-38.4	NA2	B-II:20
Poincloux et al[44]	R	64, 62	77.0	15 (24.2)	NA	NA	0	NA
Hwang et al[45]	R	69	68.2	33 (47.8)	16.5	NA	0	0
Paspatis et al[46]	RCT	124	74.9	21 (16.9)	15.7	NA	NA2	0
Rosa et al[47]	R	68	70.8	NA	16.8	NA	0	0
Yang et al[48]	R	171, 169	69.3	73 (43.2)	15.01	10-45	32	B-II:1
Yoon et al[49]	P	52	68.1	19 (36.5)	20.1	12-40	52	0
Harada et al[50]	R	30	78.0	23 (76.7)	18.0	10-39	30	NA
Total		2511, 2503		773 (36.7)		5-45	353 (20.2)	48 (2.4)

¹Median value;

²Studies that included patients with a history of prior endoscopic sphincterotomy, but their exact numbers were not described. EST: Endoscopic sphincterotomy; R: Retrospective; P: Prospective; RCT: Randomized controlled trial; NA: Not available; B-I: Billroth-I anastomosis; B-II: Billroth-II anastomosis; R-Y: Roux-en-Y anastomosis.

Table 2 Procedure characteristics and outcomes of endoscopic papillary large balloon dilation with endoscopic sphincterotomy n (%)

Ref.	Size of EST	Balloon size, mm	Duration of inflated balloon, s	Initial success	No. ofsessions, mean	Success without EML	Use of EML	Overall success
Ersoz et al[21]	Large	12-20	20-45	48 (82.8)	1.17	54 (93.1)	4 (6.9)	58 (100)
Hwang et al[22]	Limited	15-18	30-60	NA	NA	30 (100.0)	0 (0.0)	30 (100)
Maydeo et al[23]	Large	12-20	30	57 (95.0)	1.05	57 (95.0)	3 (5.0)	60 (100)
Minami et al[24]	Limited	20	NA	87 (98.9)	1.00	87 (98.9)	1 (1.1)	88 (100)
Heo et al[25]	Limited	12-20	60	83 (83.0)	1.12	90 (90.0)	8 (8.0)	97 (97.0)
Lee et al[26]	Limited	15-20	30-60	NA	NA	52 (94.5)	3 (5.5)	55 (100)
Kim et al[27]	Limited	12-20	60-90	NA	NA	22 (63.1)	9 (25.7)	31 (88.6)
Lee et al[28]	Limited	13-20	20-60	35 (85.3)	1.20	37 (90.3)	4 (9.8)	41 (100)
Misra et al[29]	Large	15-20	30-45	NA	NA	45 (90.0)	5 (10.0)	50 (100)
Attasaranya et al[30]	Large	12-18	NA	102 (95.3)1	1.00	78 (72.9)	29 (27.1)	102 (95.3)
Espinel et al[31]	Large	12-20	30-45	93 (100.0)1	1.00	90 (96.8)	3 (3.2)	93 (100)
Itoi et al[32]	Large	15-20	15-30	51 (96.2)1	1.04	50 (94.3)	3 (5.7)	53 (100)
Kim et al[33]	Limited	15-18	NA	23 (85.2)1	1.27	18 (66.7)	9 (33.3)	27 (100)
Itoi et al[34]	Large	15-18	10	17 (94.4)	1.06	14 (77.8)	4 (22.2)	18 (100)
Kurita et al[35]	Prior	15-20	30	23 (95.8)	1.00	23 (95.8)	1 (4.2)	23 (95.8)
Ghazanfar et al[36]	Large	15-18	NA	52 (61.9)	1.28	67 (79.7)	0 (0.0)	67 (79.7)
Kim et al[37]	Prior	12-18	20-60	68 (97.1)	1.02	69 (98.6)	1 (1.4)	70 (100)
Youn et al[38]	Limited	15-20	30-60	93 (92.1)1	1.08	94 (93.1)	7 (6.9)	101 (100)
Kim et al[39]	Limited	12-20	30	63 (87.5)1	1.14	64 (88.9)	6 (8.3)	70 (97.2)
Stefanidis et al[40]	Large	15-20	10-12	44 (97.7)	1.00	44 (97.7)	0 (0.0)	44 (97.7)
Rebelo et al[41]	Limited	12-18	60	25 (83.3)1	1.14	23 (76.7)	6 (20.0)	29 (96.7)
Sakai et al[42]	Limited	12-20	NA	49 (83.1)1	1.30	51 (86.4)	8 (13.6)	57 (96.6)
Park et al[43]	Variable	12-20	30-180	3573 (65.4)1	1.46	4844 (78.4)	1234 (19.9)	6024 (97.6)
Poincloux et al[44]	Large	15-20	30-60	62 (96.9)	1.05	61 (95.3)	3 (4.7)	64 (100)
Hwang et al[45]	Limited	12-20	60	65 (94.2)1	1.02	51 (73.9)	18 (26.1)	66 (95.7)
Paspatis et al[46]	Large	15-20	30-60	NA	NA	102 (81.8)	4 (3.2)	106 (85.0)
Rosa et al[47]	Limited	12-18	60	56 (82.4)1	1.10	55 (80.9)	10 (14.7)	65 (95.6)
Yang et al[48]	Limited	12-18	NA	163 (95.3)1	1.00	102 (59.6)	66 (38.6)	163 (95.3)
Yoon et al[49]	Prior	12-20	60-120	NA	1.70	36 (69.2)	12 (23.1)	48 (92.4)
Harada et al[50]	Prior	15-20	30	29 (96.7)1	1.00	27 (90.0)	3 (10.0)	29 (96.7)
Total		12-20	10-180	1745 (84.0)	1.202	2077 (83.2)	353 (14.1)	2407 (96.5)

¹Studies which were designed to include cases where endoscopic mechanical lithotripsy was performed along with the first session of endoscopic papillary large balloon dilation;

²Calculated by dividing total number of procedures into total number of sessions which was calculated by multiplying each mean number of session with each number of procedures;

³Total number of procedures was 546 due to missing data;

⁴Total number of procedures was 617 due to missing data. EST: Endoscopic sphincterotomy; EML: Endoscopic mechanical lithotripsy; Prior: Prior endoscopic sphincterotomy; NA: Not available.

Table 3 Adverse events of endoscopic papillary large balloon dilation with endoscopic sphincterotomy n (%)

Ref.	Overall AEs	Pancreatitis	Bleeding	Perforation	Others	AE-related surgery	AE-related death
Ersoz et al[21]	9 (15.5)	2 (3.4)	5 (8.6)	0 (0.0)	2 (3.4)	0 (0.0)	0 (0.0)
Hwang et al[22]	1 (3.3)	0 (0.0)	1 (3.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Maydeo et al[23]	5 (8.3)	0 (0.0)	5 (8.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Minami et al[24]	15 (17.0)	1 (1.1)	1 (1.1)	0 (0.0)	13 (14.8)	0 (0.0)	0 (0.0)
Heo et al[25]	5 (5.0)	4 (4.0)	0 (0.0)	0 (0.0)	1 (1.0)	0 (0.0)	0 (0.0)
Lee et al[26]	2 (3.6)	0 (0.0)	2 (3.6)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Kim et al[27]	1 (2.8)	0 (0.0)	0 (0.0)	1 (2.8)	0 (0.0)	0 (0.0)	0 (0.0)
Lee et al[28]	3 (7.2)	2 (4.8)	1 (2.4)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Misra et al[29]	7 (14.0)	4 (8.0)	3 (6.0)	0 (0.0)	0 (0.0)	1 (2.0)	0 (0.0)
Attasaranya et al[30]	6 (5.6)	0 (0.0)	2 (1.9)	1 (0.9)	3 (2.8)	1 (0.9)	0 (0.0)
Espinel et al[31]	2 (2.2)	1 (1.1)	1 (1.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Itoi et al[32]	2 (3.8)	1 (1.9)	0 (0.0)	0 (0.0)	1 (1.9)	0 (0.0)	0 (0.0)
Kim et al[33]	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Itoi et al[34]	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Kurita et al[35]	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Ghazanfar et al[36]	6 (7.1)	3 (3.6)	3 (3.6)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.2)
Kim et al[37]	1 (2.3)	1 (2.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Youn et al[38]	7 (6.9)	2 (2.0)	2 (2.0)	1 (1.0)	2 (2.0)	0 (1.0)	0 (1.0)
Kim et al[39]	6 (8.3)	5 (6.9)	0 (0.0)	0 (0.0)	1 (1.4)	0 (0.0)	0 (0.0)
Stefanidis et al[40]	2 (4.4)	1 (2.2)	1 (2.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Rebelo et al[41]	4 (13.3)	1 (3.3)	0 (0.0)	0 (0.0)	3 (10.0)	0 (0.0)	0 (0.0)
Sakai et al[42]	4 (6.8)	0 (0.0)	1 (1.7)	1 (1.7)	2 (3.4)	0 (0.0)	0 (0.0)
Park et al[43]	71 (11.2)	13 (2.1)	48 (7.6)	7 (1.1)	3 (0.4)	2 (0.3)	4 (0.6)
Poincloux et al[44]	9 (14.1)	2 (3.1)	5 (7.8)	0 (0.0)	2 (3.1)	0 (0.0)	0 (0.0)
Hwang et al[45]	5 (7.2)	3 (4.3)	0 (0.0)	1 (1.4)	1 (1.4)	2 (2.9)	0 (0.0)
Paspatis et al[46]	17 (13.7)	4 (3.2)	6 (4.8)	2 (1.6)	5 (4.1)	0 (0.0)	1 (0.8)
Rosa et al[47]	10 (14.7)	9 (13.2)	0 (0.0)	0 (0.0)	1 (1.5)	0 (0.0)	0 (0.0)
Yang et al[48]	8 (4.7)	2 (1.2)	4 (2.4)	1 (0.6)	1 (0.6)	0 (0.0)	0 (0.0)
Yoon et al[49]	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Harada et al[50]	1 (3.3)	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.3)	0 (0.0)	0 (0.0)
Total	809 (8.3)	61 (2.4)	91 (3.6)	15 (0.6)	42 (1.7)	6 (0.2)	6 (0.2)

AE: Adverse event.

Table 4 Comparison between endoscopic papillary large balloon dilation with and without endoscopic sphincterotomy n (%)

	EPLBD with EST	No. of studies	EPLBD without EST	No. of studies	P value
No. of procedures	2511	30	413	3
Mean of mean age, yr	69.6 ± 8.61	29	70.3 ± 2.31	3	0.808
Periampullary diverticulum	773 (36.7)	23	122 (33.2)	2	0.186
Initial success	1745 (84.0)	24	285 (76.2)	3	< 0.001
Success without EML	2077 (83.2)	30	306 (76.7)	3	0.001
Use of EML	353 (14.1)	30	86 (21.6)	3	< 0.001
Overall success	2407 (96.5)	30	388 (97.2)	3	0.432
Overall adverse events	209 (8.3)	30	29 (7.0)	3	0.370
Pancreatitis, total; M/Mod/S/F	61; 51/9/0/1 (2.4)	30	16; 14/2/0/0 (3.9)	3	0.089
Bleeding, total; M/Mod/S/F	91; 75/11/2/2 (3.6)2	30	8; 7/1/0/0 (1.9)	3	0.079
Perforation, total; M/Mod/S/F	15; 3/6/3/3 (0.6)	30	2; 0/2/0/0 (0.5)	3	1.000
Other adverse events	42 (1.7)	30	3; 3/0/0/0 (0.7)	3	0.148
AE-related surgery	6 (0.2)	30	0 (0)	3	1.000
AE-related death	6 (0.2)	30	0 (0)	3	1.000

¹mean ± SD;

²One case of bleeding was not graded for severity. M: Mild; Mod: Moderate; S: Severe; F: Fatal; EPLBD: Endoscopic papillary large balloon dilation; EST: Endoscopic sphincterotomy; EML: Endoscopic mechanical lithotripsy; AE: Adverse event.

Table 5 Baseline clinical characteristics of the patients on endoscopic papillary large balloon dilation without endoscopic sphincterotomy n (%)

Ref.	Study design	No. ofprocedures	Mean age, yr	No. of periampullary diverticulum	Mean size of largest stone, mm	Range of stone size, mm	Altered anatomy
Jeong et al[51]	R	38	68	NA	17.7	12-31	0
Hwang et al[45]	R	62	70.4	16 (25.8)	15.7	12-26	0
Park et al[43]	R	313	72.6	106 (34.6)	15.0	10-37	B-II:11
Total		413	71.81	122 (33.2)	15.42	10-37	11 (2.7)

¹Calculated by dividing total number of procedures into total number of the parameter which was calculated by multiplying each mean value with each number of procedures;

²A retrospective multicenter study where missing data are present in each analyzed variable. R: Retrospective; B-II: Billroth-II anastomosis.

Table 6 Procedure characteristics and outcomes of endoscopic papillary large balloon dilation without endoscopic sphincterotomy n (%)

Ref.	Balloon size, mm	Duration of inflated balloon, s	Initial success	No. of sessions, mean	Success without EML	Use of EML	Overall success
Jeong et al[51]	15-18	60	25 (65.8)	1.20	29 (76.3)	9 (23.7)	37 (97.4)
Hwang et al[45]	12-20	60	57 (91.9)1	1.05	50 (80.6)	12 (19.4)	60 (96.8)
Park et al[43]	12-20	30-180	2033 (74.1)1	1.33	2274 (76.0)	654 (21.7)	2914 (97.3)
Total	12-20	30-180	285 (76.2)	1.272	306 (76.7)	86 (21.6)	388 (97.2)

¹Studies which were designed to include cases where endoscopic mechanical lithotripsy was performed along with the first session of endoscopic papillary large balloon dilation;

²Calculated by dividing total number of procedures into total number of sessions which was calculated by multiplying each mean number of session with each number of procedures;

³Total number of procedures was 274 due to missing data;

⁴Total number of procedures was 299 due to missing data. EML: Endoscopic mechanical lithotripsy.

Table 7 Adverse events of endoscopic papillary large balloon dilation without endoscopic sphincterotomy n (%)

Ref.	Overall AEs	Pancreatitis	Bleeding	Perforation	Others	AE-related surgery	AE-related death
Jeong et al[51]	1 (2.6)	1 (2.6)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Hwang et al[45]	4 (6.4)	4 (6.4)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Park et al[43]	24 (7.7)	11 (3.5)	8 (2.6)	2 (0.6)	3 (1.0)	0 (0.0)	0 (0.0)
Total	29 (7.0)	16 (3.9)	8 (1.9)	2 (0.5)	3 (0.7)	0 (0.0)	0 (0.0)

AE: Adverse event.

Table 8 Comparison of adverse events among endoscopic papillary large balloon dilation with large, limited and without endoscopic sphincterotomy n (%)

	EPLBD with large EST	EPLBD with limited EST	EPLBD without EST	P value
No. of procedures	756	946	413
Overall adverse event	65 (8.6)	71 (7.5)	29 (7.0)	0.568
Pancreatitis	18 (2.4)	29 (3.1)	16 (3.9)	0.349
Bleeding	31 (4.1)	12 (1.3)	8 (1.9)	0.0011
Perforation	3 (0.4)	5 (0.5)	2 (0.5)	1.000
Other adverse events	13 (1.7)	25 (2.6)	3 (0.7)	0.054
AE-related surgery	2 (0.3)	2 (0.2)	0 (0.0)	0.832
AE-related death	2 (0.3)	0 (0.0)	0 (0.0)	0.166

¹EPLBD with large EST vs EPLBD with limited EST, P < 0.001; EPLBD with large EST vs EPLBD without EST, P = 0.049; EPLBD with limited EST vs EPLBD without EST, P = 0.35. EPLBD: Endoscopic papillary large balloon dilation; EST: Endoscopic sphincterotomy; AE: Adverse event.

Table 9 Comparison among endoscopic sphincterotomy, endoscopic papillary balloon dilation, and endoscopic papillary balloon dilation with endoscopic sphincterotomy n (%)

	EST1	EPBD1	No. of studies	EPLBD with EST	No. of studies	P value
No. of procedures	890	878	15	2511	30
Mean age, range, yr	47-71	49-75	15	40-82	29
Mean stone size, range, mm	7.3-16.9	7-15.6	15	5-45	25
Initial success	322 (80.9)	285 (73.5)	7	1745 (84.0)	24	< 0.001
Use of EML	121 (13.3)	162 (19.6)	13	353 (14.1)	30	< 0.001
Overall success	776 (95.3)	733 (90.1)	13	2407 (96.5)	30	< 0.001
Overall adverse events	113 (12.7)	106 (12.1)	15	209(8.3)	30	< 0.001
Pancreatitis	36 (4.3)	71 (8.6)	14	61 (2.4)	30	< 0.001
Bleeding	33 (4.8)	1 (0.1)	12	91 (3.6)	30	< 0.001
Perforation	3 (0.5)	2 (0.3)	9	15 (0.6)	30	0.941
AE-related death	2 (0.3)	4 (0.7)	7	6 (0.24)	30	0.152

¹Results of a meta-analysis by Weinberg et al[18]. EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; EPLBD: Endoscopic papillary large balloon dilation; EML: Endoscopic mechanical lithotripsy.

Table 10 Recommendations for successful endoscopic papillary large balloon dilation

1 EPLBD with large, especially full-incision EST should be avoided

2 EPLBD with limited EST is recommended to be performed, even before attempting trials of a standard technique with large EST, when the stone is seen to be too large on cholangiogram

3 EPLBD without EST may be useful in some patients with coagulopathy, periampullary diverticulum, or surgically altered anatomy

4 In patients with obvious distal bile duct strictures, EPBLD should be avoided. If there is a suspicion of strictures, using the pulling method of a large inflated retrieval balloon through the site is recommended to confirm an existence

5 The intended maximal target diameter of the balloon should be determined based on the diameter of the largest stones, but should not exceed the diameter of the distal bile duct

6 The balloon should always be inflated gradually, starting from a smaller diameter step of the balloon than the intended maximal target diameter

7 Further balloon inflation must be ceased, if the central waist of the balloon does not disappear or the patient indicates severe pain during balloon inflation at any step

EST: Endoscopic sphincterotomy; EPLBD: Endoscopic papillary large balloon dilation.