Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

Table 1 Patient characteristics and endoscopic retrograde cholangio pancreatography related data n (%) (n = 244)

Characteristics	Value
Age (yr), mean ± SD (range)	70.8 ± 10.2 (44-95)
Sex
Male	130 (53.3)
Female	114 (46.7)
Aspirin	3 (1.2)
Total bilirubin (mg/dL), pre-procedure, mean ± SD (range)	7.09 ± 6.45 (0.2-28.9)
Normal	53 (21.7)
Elevated	191 (78.3)
Hyperamylasemia, pre-procedure	14 (5.7)
Cholangitis, pre-procedure	68 (27.9)
Diagnosis
Cholangiocarcinoma	118 (48.4)
Hilar	75 (63.6)
Distal	43 (36.4)
Pancreatic cancer	79 (32.4)
Head	68 (86.1)
Body/Tail	11 (13.9)
Gallbladder cancer	21 (8.6)
Ampullary cancer	18 (7.4)
Hepatocellular carcinoma	3 (1.2)
Others	5 (2.0)
Pancreatic duct invasion
Yes	85 (34.8)
No	159 (65.2)
Lymph node metastasis
Yes	170 (69.7)
No	73 (29.9)
Pancreatic duct injection
0	187 (76.6)
1-2	24 (9.8)
≥ 3	33 (13.5)
ERPD	4 (1.6)
Stent success rate	244 (100)
Number of initially inserted SEMS
1	230 (94.3)
2	14 (5.7)
Stent type
Uncovered	190 (77.9)
Covered	54 (22.1)
Post-ERCP complication
Present	9 (3.7)
Absent'	234 (95.9)
Post-ERCP complication type
Pancreatitis	7 (2.9)
Mild / moderate	6 (2.5)/1 (0.4)
Bleeding, mild	2 (0.8)
Perforation	0 (0)
Post-ERCP hyperamylasemia	30 (12.3)
Stent complication
None	199 (81.6)
Stent occlusion	44 (18.0)
Stent migration	1 (0.4)
Patency
No further procedure	199 (81.6)
ERBD restent	1 (0.4)
SEMS restent	32 (13.1)
PTBD	12 (4.9)

SEMS: Self-expandable metal stent; ERPD: Endoscopic retrograde pancreatic drainage; ERBD: Endoscopic retrograde biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 2 Characteristics and complications according to the cancer type n (%)

	Cholangiocarcinoman = 118	Pancreatic cancern = 79	non-pancreaticobiliary cancern = 47	P value
Age (yr), mean ± SD	73.5 ± 9.4	67.8 ± 10.4	69.3 ± 10.3	0.002
Hyperamylasemia, pre-procedure	6 (5.1)	3 (3.8)	5 (10.6)	0.273
Cholangitis, pre-procedure	28 (23.7)	19 (24.1)	21 (44.7)	0.021
Pancreatic duct invasion				< 0.001
Yes	12 (10.2)	64 (81.0)	9 (19.1)
No	106 (89.8)	15 (19.0)	38 (80.9)
Lymph node metastasis				0.345
Yes	77 (65.3)	58 (73.4)	35 (74.5)
No	41 (34.7)	21 (26.6)	12 (25.5)
Pancreatic duct injection				0.606
0	92 (78.0)	59 (74.7)	36 (76.6)
1-2	8 (6.8)	9 (11.4)	7 (14.9)
≥ 3	18 (15.3)	11 (13.9)	4 (8.5)
Number of initially inserted SEMS				0.004
1	106 (89.8)	79 (100.0)	45 (95.7)
2	12 (10.2)	0 (0.0)	2 (4.3)
Post-ERCP complication				0.696
Present	5 (4.2)	2 (2.5)	2 (4.3)
Absent	113 (95.8)	77 (97.5)	45 (95.7)
Post-ERCP complication type				0.914
Pancreatitis	4 (3.4)	1 (1.3)	2 (4.3)	0.681
Mild/moderate	3 (2.5)/1 (0.8)	1 (1.3)/0 (0)	2 (4.3)/0 (0)
Bleeding, mild	1 (0.8)	1 (1.3)	0 (0)
Perforation	0 (0)	0 (0)	0 (0)
Post-ERCP hyperamylasemia	13 (11.0)	9 (11.4)	8 (17.0)
Stent complication				0.539
None	90 (76.3)	70 (88.6)	39 (83.0)
Stent occlusion	27 (22.9)	9 (11.4)	8 (17.0)
Stent migration	1 (0.8)	0 (0)	0 (0)
Patency				0.161
No further procedure	90 (76.3)	70 (88.6)	39 (83)
ERBD restent	1 (0.8)	0 (0)	0 (0)
SEMS restent	20 (16.9)	9 (11.4)	3 (6.4)
PTBD	7 (5.9)	0 (0)	5 (10.6)

SEMS: Self-expandable metal stent; ERBD: Endoscopic retrograde biliary drainage; PTBD: Percutaneous transhepatic biliary drainage.

Table 3 Rates of complications on biliary stenting with limited endoscopic sphincterotomy according to location of cholangiocarcinoma n (%)

	Hilarn = 75	Distaln = 43	P value
Post-ERCP complication type			0.717
Pancreatitis	3 (4.0)	1 (2.3)
Mild/moderate	2 (2.7)/1 (1.3)	1 (2.3)/0 (0)
Bleeding, mild	1 (1.3)	0 (0.0)
Perforation	0 (0.0)	0 (0.0)
Post-ERCP hyperamylasemia	7 (9.3)	5 (11.6)
Stent complication			0.756
None	57 (76.0)	33 (76.7)	1.000
Stent occlusion	17 (22.7)	10 (23.3)
Stent migration	1 (1.3)	0 (0.0)

ERCP: Endoscopic retrograde cholangio pancreatography.

Table 4 Rates of complications on biliary stenting with limited endoscopic sphincterotomy according to location of pancreatic cancer

	Headn = 68	Body/tailn = 11	P value
Post-ERCP complication type			1.000
Pancreatitis	1 (1.5)	0 (0.0)
Mild/moderate	1 (1.5)	0 (0.0)
Bleeding, mild	1 (1.5)	0 (0.0)
Perforation	1 (1.5)	0 (0.0)
Post-ERCP hyperamylasemia	8 (11.8)	2 (18.2)	0.624
Stent complication			1.000
None	60 (88.2)	10 (90.9)
Stent occlusion	8 (11.8)	1 (9.1)
Stent migration	0 (0.0)	0 (0.0)

ERCP: Endoscopic retrograde cholangio pancreatography.

Table 5 Rates of complications on biliary stenting with limited endoscopic sphincterotomy according to stent type

	Uncoveredn = 190	Coveredn = 54	P value
Normal	181 (95.3)	49 (90.7)
Abnormal	9 (4.7)	5 (9.3)
Post-ERCP complication			1.000
Present	7 (3.7)	2 (3.7)
Absent'	183 (96.3)	52 (96.3)
Post-ERCP complication type			0.838
Pancreatitis	5 (2.6)	2 (3.7)
Mild / moderate	4 (2.1) / 1 (0.5)	2 (3.7) / 0 (0)
Bleeding, mild	2 (1.1)	0 (0)
Perforation	0 (0)	0 (0)
Post-ERCP hyperamylasemia	25 (13.2)	5 (9.3)	0.638
Stent complication			0.758
None	156 (82.1)	43 (79.6)
Stent occlusion	33 (17.4)	11 (20.4)
Stent migration	1 (0.5)	0 (0)
Patency			0.012
No further procedure	156 (82.1)	43 (79.6)
ERBD restent	1 (0.5)	0 (0)
SEMS restent	28 (14.7)	4 (7.4)
PTBD	5 (2.6)	7 (13)

SEMS: Self-expandable metal stent; ERBD: Endoscopic retrograde biliary drainage; PTBD: Percutaneous transhepatic biliary drainage; ERCP: Endoscopic retrograde cholangio pancreatography.

Table 6 Characteristics according to complications on biliary stenting with limited endoscopic sphincterotomy n (%)

	No complicationn = 235	Complicationn = 9	P value
Age (yr), mean ± SD (range)	70.61 ± 10.33	75.27 ± 5.55	0.993
Gender			1.000
Male	126 (53.6)	5 (55.5)
Female	109 (46.6)	4 (44.5)
Total bilirubin (mg/dL), pre-procedure, mean ± SD	7.00 ± 6.46	8.38 ± 6.54	0.362
Normal	52 (22.2)	1 (11.1)	0.453
Elevated	183 (77.8)	8 (88.9)
Hyperamylasemia, pre-procedure	13 (5.5)	1 (11.1)	0.485
Cholangitis, pre-procedure	64 (27.2)	4 (44.4)	0.472
Diagnosis			0.748
Cholangiocarcinoma	112 (47.6)	6 (66.7)
Hilar	71 (30.2)	4 (44.4)
Distal	41 (17.4)	2 (22.2)
Pancreatic cancer	77 (32.8)	2 (22.2)
Head	66 (28.1)	2 (22.2)
Body/tail	11 (4.7)	0 (0.0)
Gallbladder cancer	20 (8.5)	1 (11.1)
Ampullary cancer	18 (7.7)	0 (0.0)
Hepatocellular carcinoma	3 (1.3)	0 (0.0)
Others	5 (2.1)	0 (0.0)
Pancreatic duct invasion			0.324
Yes	80 (34.0)	5 (55.6)
No	155 (66.0)	4 (44.4)
Lymph node metastasis			0.176
Yes	166 (70.6)	5 (55.6)
No	69 (29.4)	4 (44.4)
Pancreatic duct injection			0.662
0	181 (77.0)	6 (66.7)
1-2	23 (9.8)	1 (11.1)
≥ 3	31 (13.2)	2 (22.2)
Number of inserted SEMS			0.031
1	224 (95.3)	7 (77.8)
2	11 (4.7)	2 (22.2)
Stent type			1.000
Uncovered	183 (77.9)	7 (77.8)
Covered	52 (22.1)	2 (22.2)
Stent complication			1.000
Stent occlusion	42 (17.9)	2 (22.2)
Stent migration	1 (0.4)	0 (0.0)
Patency			0.512
No further procedure	192 (81.7)	7 (77.8)
ERBD restent	1 (0.4)	0 (0.0)
SEMS restent	31 (13.2)	1 (11.1)
PTBD	11 (4.7)	1 (11.1)

SEMS: Self-expandable metal stent; ERBD: Endoscopic retrograde biliary drainage; PTBD: Percutaneous transhepatic biliary drainage; ERCP: Endoscopic retrograde cholangio pancreatography.