Endoscopic papillary large balloon dilation in patients with periampullary diverticula

Table 1 Baseline characteristics of patients n (%)

Variable	Total (n = 223)	PAD group (n = 93)	Non-PAD group (n = 130)	P value
Mean age (yr)	72.0 ± 10.4 (39-92)	75.2 ± 8.8 (51-92)	69.7 ± 10.9 (39-90)	0.000
Sex (male/female)	122:101 (54.7:45.3)	46:47 (49.5:50.5)	76:54 (58.5:41.5)	0.220
BMI (kg/m2)	22.6 ± 3.1	22.5 ± 2.8	22.6 ± 3.3	0.947
Billroth II gastrectomy	26 (11.7)	7 (7.5)	19 (14.6)	0.138
Large balloon dilation
With ES	132 (59.2)	59 (63.4)	73 (56.2)	0.334
Without ES	91 (40.8)	34 (36.6)	57 (43.8)
Precutting with needle knife	25 (11.2)	9 (9.7)	16 (12.3)	0.668
CBD stones
Mean diameter of stone (mm)	15.9 ± 5.8 (10-40)	16.4 ± 6.0 (10-37)	15.5 ± 5.7 (10-40)	0.252
Number of stones
1/2/≥ 3	119/35/68	49/15/29	70/20/39	0.835
Types of stones
Brown/black/cholesterol	182/33/2 (83.9/15.2/0.9)	82/9/0 (90.1/9.9/0)	100/24/2 (79.4/19.0/1.6)	0.144
Mean diameter of CBD (mm)	19.9 ± 5.3 (10-37)	20.0 ± 5.0 (10-35)	19.8 ± 5.4 (10-37)	0.743
Distal CBD angulation (degree)	140.6 ± 21.9	142.1 ± 21.8	139.4 ± 22.0	0.444
Balloon dilation
Dilating balloon size (mm)	15.6 ± 2.4 (12-20)	15.5 ± 2.4 (12-20)	15.8 ± 2.4 (12-20)	0.374
Duration of ballooning (s)	38.3 ± 16.1(10–60)	36.1 ± 15.0 (10–60)	39.9 ± 16.8 (10–60)	0.081

Values are presented as mean ± SD (range). PAD: Periampullary diverticula; BMI: Body mass index; ES: Endoscopic sphincterotomy; CBD: Common bile duct.

Table 2 Comparison of outcomes between the two groups n (%)

	PAD group (n = 93)			Non-PAD group (n = 130)			P value1
	EPLBD + ES (n = 59)	EPLBD - ES (n = 34)	P value	EPLBD + ES (n = 73)	EPLBD - ES(n = 57)	P value
Overall stone removal	57 (96.6)	33 (97.1)	1.000	72 (98.6)	54 (94.7)	0.319	1.000
Complete stone removal in 1st session	43 (72.9)	30 (88.2)	0.116	51 (69.9)	42 (73.7)	0.632	0.277
Mechanical lithotripsy	3 (5.1)	0 (0.0)	0.297	9 (12.3)	6 (10.5)	0.750	0.026

¹Comparison between the periampullary diverticula (PAD) and non-PAD groups. EPLBD: Endoscopic papillary large balloon dilation; ES: Endoscopic sphincterotomy; EPLBD+ES: Endoscopic papillary large balloon dilation with limited endoscopic sphincterotomy; EPLBD-ES: Endoscopic papillary large balloon dilation without endoscopic sphincterotomy.

Table 3 Baseline characteristics and outcomes of patients by periampullary diverticula type n (%)

	Type 1 (n = 18)	Type 2 (n = 41)	Type 3 (n = 34)	P value
Mean age (yr)	75.9 ± 6.7	76.5 ± 8.7	73.2 ± 9.9	0.268
Large balloon dilation
With ES	9 (50.0)	27 (65.9)	23 (67.6)	0.257
Without ES	9 (50.0)	14 (34.1)	11 (32.4)
Mean diameter of stone (mm)	17.8 ± 6.7	15.9 ± 5.5	16.1 ± 6.2	0.514
Mean diameter of CBD (mm)	20.8 ± 4.9	20.5 ± 5.6	19.0 ± 4.3	0.324
Distal CBD angulation (degree)	141.8 ± 9.6	143.6 ± 29.0	140.5 ± 16.6	0.869
Balloon dilation
Dilating balloon size (mm)	14.7 ± 2.5	15.8 ± 2.4	15.5 ± 2.4	0.261
Duration of ballooning (s)	30.6 ± 12.6	36.3 ± 12.8	38.8 ± 17.9	0.165
Overall stone removal	17 (94.4)	41 (100)	32 (94.1)	0.698
Complete stone removal in 1st session	14 (77.8)	33 (80.5)	26 (76.5)	0.912
Mechanical lithotripsy	1 (5.6)	1 (2.4)	1 (2.9)	0.679

Values are presented as mean ± SD. Type 1: When major papilla is located inside the diverticulum, Type 2: In the margin of the diverticulum; and Type 3: Outside the diverticulum. PAD: Periampullary diverticula; ES: Endoscopic sphincterotomy; CBD: Common bile duct.

Table 4 Comparison of complications between the two groups n (%)

	PAD (n = 93)			Non-PAD (n = 130)			P value1
	EPLBD + ES (n = 59)	EPLBD - ES (n = 34)	P value	EPLBD + ES (n = 73)	EPLBD - ES (n = 57)	P value
Pancreatitis	2 (3.4)	5 (14.7)	0.095	7 (9.6)	5 (8.8)	0.873	0.809
Perforation	0 (0.0)	0 (0.0)	NA	0 (0.0)	1 (1.8)	0.438	1.000
Bleeding	2 (3.4)	3 (8.8)	0.351	7 (9.6)	4 (7.0)	0.601	0.548
Major	0 (0.0)	0 (0.0)		1 (1.4)	0 (0.0)
Minor	2 (13.4)	3 (8.8)		6 (8.2)	4 (7.0)
Hyperamylasemia	4 (6.8)	5 (14.7)	0.279	15 (20.5)	6 (10.5)	0.123	0.232
Mortality	0 (0.0)	0 (0.0)	NA	1 (1.4)	1 (1.8)	1.000	0.230

¹Comparison of the periampullary diverticula (PAD) and non-PAD groups. EPLBD: Endoscopic papillary large balloon dilation; ES: Endoscopic sphincterotomy; EPLBD + ES: Endoscopic papillary large balloon dilation with limited ES; EPLBD - ES: Endoscopic papillary large balloon dilation without ES; NA: Not applicable.

Table 5 Complications of endoscopic papillary large balloon dilation by periampullary diverticula subtype n (%)

	PAD subtype (n = 93)
	Type 1	Type 2	Type 3	P value
	(n = 18)	(n = 41)	(n = 34)
Pancreatitis	1 (5.6)	4 (9.8)	2 (5.9)	0.913
Perforation	0 (0.0)	0 (0.0)	0 (0.0)	NA
Bleeding
Major	0	0	0 (0.0)	NA
Minor	1 (5.6)	2 (4.9)	2 (5.9)	0.930
Hyperamylasemia	0 (0.0)	5 (12.2)	4 (11.8)	0.240
Mortality	0 (0.0)	0 (0.0)	0 (0.0)	NA

Type 1: When major papilla is located inside the diverticulum; Type 2: In the margin of the diverticulum; and Type 3: Outside the diverticulum. EPLBD: Endoscopic papillary large balloon dilation; PAD: Periampullary diverticula; NA: Not applicable.