Endoscopic retrograde cholangiopancreatography for bile duct stones in patients with a performance status score of 3 or 4

Table 1 Baseline characteristics of the patients

	All patients		P value	Propensity score-matched patients		P value
	Patients with a PS 0-2 (n = 1113)	Patients with a PS 3 or 4 (n = 230)		Patients with a PS 0-2 (n = 196)	Patients with a PS 3 or 4 (n = 196)
Age [mean (SD)]	72.9 (14.0)	84.4 (9.1)	< 0.001	83.6 (8.2)	83.4 (9.2)	0.79
Female (%)	498 (44.7)	146 (63.5)	< 0.001	113 (57.7)	117 (59.7)	0.76
Indications of ERCP for CBDS
Acute cholangitis (%)	607 (54.5)	194 (84.3)	< 0.001	160 (81.6)	160 (81.6)	1.0
Biliary pancreatitis (%)	59 (5.3)	5 (2.2)	0.041	5 (2.6)	5 (2.6)	1.0
Obstructive jaundice without cholangitis (%)	263 (23.6)	20 (8.7)	< 0.001	21 (10.7)	20 (10.2)	1.0
Asymptomatic CBDS (%)	184 (16.5)	11 (4.8)	< 0.001	10 (5.1)	11 (5.6)	1.0
Underlying diseases
Diabetes Mellitus (%)	78 (7.0)	12 (5.2)	0.39	14 (7.1)	12 (6.1)	0.84
Cardiovascular diseases (%)	152 (13.7)	42 (18.3)	0.080	40 (20.4)	39 (19.9)	1.0
Cerebrovascular diseases (%)	55 (4.9)	53 (23.0)	< 0.001	31 (15.8)	31 (15.8)	1.0
Dialysis (%)	35 (3.1)	8 (3.5)	0.84	7 (3.6)	8 (4.1)	1.0
Liver cirrhosis (%)	15 (1.3)	0 (0.0)	0.089	0 (0)	0 (0)	1.0
Multiple underlying diseases (%)	99 (8.9)	37 (16.1)	0.002	33 (16.8)	30 (15.3)	0.78
Antithrombotic treatment	280 (25.2)	94 (40.9)	< 0.001	80 (40.8)	73 (37.2)	0.54
Billroth-1 reconstruction (%)	28 (2.5)	6 (2.6)	1.0	8 (4.1)	6 (3.1)	0.79
Post-cholecystectomy (%)	124 (11.1)	19 (8.3)	0.24	19 (9.7)	18 (9.2)	1.0
Presence of gallstones (%)	715 (64.2)	147 (63.9)	0.94	123 (62.8)	121 (61.7)	0.92
Normal serum bilirubin (%)	540 (48.5)	104 (45.2)	0.39	94 (48.0)	87 (44.4)	0.54
Platelet counts [mean (SD)] (×106/L)	19.1 (7.1)	19.5 (9.9)	0.44	18.7 (7.7)	18.6 (7.9)	0.93
PT-INR [mean (SD)]	1.2 (0.91)	1.2 (0.42)	0.29	1.3 (1.8)	1.2 (0.42)	0.47
Non-dilated CBD (< 10 mm) (%)	454 (40.8)	70 (30.4)	0.004	53 (27.0)	60 (30.6)	0.50
Periampullary diverticulum (%)	341 (30.6)	60 (26.1)	0.18	62 (31.6)	56 (28.6)	0.58
Antibiotics (%)	881 (79.2)	216 (93.9)	< 0.001	178 (90.8)	182 (92.9)	0.58
Trainees (%)	199 (17.9)	27 (11.7)	0.026	25 (12.8)	24 (12.2)	1.0
Successful biliary cannulation (%)	1099 (98.7)	225 (97.8)	0.35	192 (98.0)	192 (98.0)	1.0
Difficult biliary cannulation (%)	309 (27.8)	48 (20.9)	0.033	46 (23.5)	42 (21.4)	0.72
Contrast-assisted cannulation (%)	772 (69.4)	168 (73.0)	0.30	135 (68.9)	143 (73.0)	0.44
Wire-guided cannulation (%)	120 (10.8)	23 (10.0)	0.82	21 (10.7)	20 (10.2)	1.0
PGW-assisted cannulation (%)	156 (14.0)	30 (13.0)	0.75	28 (14.3)	26 (13.3)	0.88
Precut sphincterotomy (%)	63 (5.7)	9 (3.9)	0.34	12 (6.1)	7 (3.6)	0.35
Pancreatic injection (%)	513 (46.1)	93 (40.4)	0.13	87 (44.4)	81 (41.3)	0.61
EST (%)	973 (87.4)	186 (80.9)	0.011	154 (78.6)	160 (81.6)	0.53
EPBD (%)	125 (11.2)	38 (16.5)	0.034	38 (19.4)	31 (15.8)	0.43
EPLBD (%)	158 (14.2)	60 (26.1)	< 0.001	53 (27.0)	50 (25.5)	0.82
Use of balloon catheter (%)	896 (80.5)	167 (72.6)	0.010	139 (70.9)	144 (73.5)	0.65
Use of basket catheter (%)	504 (45.3)	105 (45.7)	0.94	102 (52.0)	94 (48.0)	0.48
Mechanical lithotripsy (%)	189 (17.0)	33 (14.3)	0.38	35 (17.9)	32 (16.3)	0.79
Biliary stent placement (%)	945 (84.9)	192 (83.5)	0.62	157 (80.1)	164 (83.7)	0.43
Number of CBD stones [mean (SD)]	2.2 (2.7)	2.5 (2.8)	0.052	2.6 (3.4)	2.6 (3.0)	0.87
Large stones (> 10 mm) (%)	195 (17.5)	61 (26.5)	0.002	57 (29.1)	52 (26.5)	0.65
Prophylactic pancreatic stent placement (%)	169 (15.2)	32 (13.9)	0.69	34 (17.3)	30 (15.3)	0.68
Protease inhibitor (%)	453 (40.7)	65 (28.3)	< 0.001	57 (29.1)	60 (30.6)	0.83
Rectal NSAIDs (%)	117 (10.5)	10 (4.3)	0.003	11 (5.6)	9 (4.6)	0.82

CBD: Common bile duct; CBDS: Common bile duct stones; ERCP: Endoscopic retrograde cholangiopancreatography; EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; EPLBD: Endoscopic papillary large balloon dilation; PS: Performance status; PGW: Pancreatic guidewire.

Table 2 Comparison of endoscopic retrograde cholangiopancreatography-related complications between patients with a performance status score of 0-2 and 3-4

	All patients		P value	Propensity score-matched patients		P value
	Patients with a PS 0-2 (n = 1113)	Patients with a PS 3 or 4 (n = 230)		Patients with a PS 0-2 (n = 196)	Patients with a PS 3 or 4 (n = 196)
Overall complications, n (%)	100 (9.0)	16 (7.0)	0.37	9 (4.6)	13 (6.6)	0.51
Severity of overall complications			0.063			0.042
Mild (%)	65 (65.0)	6 (37.5)		7 (77.8)	3 (23.1)
Moderate (%)	29 (29.0)	8 (50.0)		2 (22.2)	8 (61.5)
Severe (%)	6 (6.0)	2 (12.5)		0 (0.0)	2 (15.4)
PEP (%)	50 (4.5)	5 (2.2)	0.14	3 (1.5)	2 (1.0)	1.0
Severity of PEP (%)			0.034			0.10
Mild (%)	34 (68.0)	3 (60.0)		3 (100.0)	0 (0.0)
Moderate (%)	14 (28.0)	0 (0.0)		0 (0.0)	0 (0.0)
Severe (%)	2 (4.0)	2 (40.0)		0 (0.0)	2 (100.0)
Bleeding (%)	18 (1.6)	4 (1.7)	0.78	1 (0.5)	4 (2.0)	0.37
Severity of bleeding (%)			0.12			0.40
Mild (%)	12 (66.7)	1 (25.0)		1 (100.0)	1 (25.0)
Moderate (%)	3 (16.7)	3 (75.0)		0 (0.0)	3 (75.0)
Severe (%)	3 (16.7)	0 (0.0)		0 (0.0)	0 (0.0)
Cholangitis (%)	18 (1.6)	4 (1.7)	0.78	3 (1.5)	4 (2.0)	1.0
Severity of cholangitis (%)			0.077			0.49
Mild (%)	14 (77.8)	1 (25.0)		2 (66.7)	1 (25.0)
Moderate (%)	4 (22.2)	3 (75.0)		1 (33.3)	3 (75.0)
Perforation (%)	10 (0.9)	0 (0.0)	0.23	1 (0.5)	0 (0.0)	1.0
Severity of perforation (%)			1.0			NA
Mild (%)	4 (40.0)	0 (0.0)		0 (0.0)	0 (0.0)
Moderate (%)	5 (50.0)	0 (0.0)		1 (100.0)	0 (0.0)
Severe (%)	1 (10.0)	0 (0.0)		0 (0.0)	0 (0.0)
Pneumonia (%)	4 (0.4)	3 (1.3)	0.10	1 (0.5)	3 (1.5)	0.62
Severity of aspiration pneumonia (%)			1.0			1.0
Mild (%)	1 (25.0)	1 (33.3)		1 (100.0)	1 (33.3)
Moderate (%)	3 (75.0)	2 (66.7)		0 (0.0)	2 (66.7)

PEP: Post-endoscopic retrograde cholangiopancreatography pancreatitis; PS: Performance status; NA: Not available.

Table 3 Comparison of outcomes of endoscopic retrograde cholangiopancreatography between patients with a performance status score of 0-2 and performance status 3-4

	All patients		P value	Propensity score-matched patients		P value
	Patients with a PS 0-2 (n = 1113)	Patients with a PS 3 or 4 (n = 230)		Patients with a PS 0-2 (n = 196)	Patients with a PS 3 or 4 (n = 196)
Therapeutic success, n (%)	1096 (98.5)	224 (97.4)	0.26	191 (97.4)	191 (97.4)	1.0
Successful complete stone removal (%)	1064 (95.6)	200 (87.0)	< 0.001	181 (92.3)	172 (87.8)	0.18
Permanent biliary stent placement (%)	32 (2.9)	24 (10.4)	< 0.001	10 (5.1)	19 (9.7)	0.12
Mean procedure time, min (SD)	27.5 (15.7)	26.5 (15.9)	0.42	26.9 (15.7)	27.3 (16.6)	0.77

PS: Performance status.

Table 4 Predictive factors for endoscopic retrograde cholangiopancreatography (ERCP)-related complications after ERCP for common bile duct stones

	Univariate analysis			Multivariate analysis
	With complications (n = 116)	Without complications (n = 1227)	P value	Odds ratio	95%CI	P value
Indications of ERCP for CBDS			< 0.001	1.1	1.05-1.2	< 0.001
Acute cholangitis (%)	44 (37.9)	757 (61.7)
Biliary pancreatitis (%)	1 (0.9)	63 (5.1)
Obstructive jaundice without cholangitis (%)	35 (30.2)	248 (20.2)
Asymptomatic CBDS (%)	36 (31.0)	159 (13.0)
Absence of antibiotics (%)	41 (35.3)	205 (16.7)	< 0.001	1.7	1.04-2.7	0.034
Mean procedure time, min [mean (SD)]	33.4 (17.3)	26.7 (15.5)	< 0.001	1.01	1.00-1.02	0.098
Difficult biliary cannulation (%)	50 (43.1)	307 (25.0)	< 0.001	1.3	0.74-2.3	0.36
Pancreatic injection (%)	69 (59.5)	537 (43.8)	0.001	1.4	0.85-2.1	0.20
Contrast-assisted cannulation (%)	68 (58.6)	872 (71.1)	0.008	0.90	0.47-1.7	0.74
Prophylactic pancreatic stent placement (%)	27 (23.3)	174 (14.2)	0.014	0.77	0.45-1.3	0.33
Normal serum bilirubin (%)	68 (58.6)	576 (46.9)	0.019	0.86	0.53-1.4	0.52
PGW-assisted cannulation (%)	24 (20.7)	162 (13.2)	0.034	1.0	0.77-1.3	0.98
Precut sphincterotomy (%)	11 (9.5)	61 (5.0)	0.050	0.96	0.76-1.2	0.76
Age [mean (SD)]	72.5 (14.8)	75.1 (13.9)	0.051	1.0	0.98-1.01	0.66
Non-dilated CBD (< 10 mm) (%)	55 (47.4)	469 (38.2)	0.058	1.3	0.82-1.9	0.30
Protease inhibitor (%)	51 (44.0)	467 (38.1)	0.23
EPBD (%)	18 (15.5)	145 (11.8)	0.24
Trainees (%)	24 (20.7)	202 (16.5)	0.24
Use of basket catheter (%)	47 (40.5)	562 (45.8)	0.29
EPLBD (%)	15 (12.9)	203 (16.5)	0.36
Platelet counts [mean (SD)] (×106/L)	19.8 (9.8)	19.1 (7.4)	0.39
EST (%)	97 (83.6)	1062 (86.6)	0.40
Rectal NSAIDs (%)	8 (6.9)	119 (9.7)	0.41
Biliary stent placement (%)	95 (81.9)	1042 (84.9)	0.42
Number of CBD stones [mean (SD)]	2.1 (3.0)	2.2 (2.7)	0.52
Post-cholecystectomy (%)	10 (8.6)	133 (10.8)	0.53
Complete stone removal (%)	108 (93.1)	1156 (94.2)	0.54
Mechanical lithotripsy (%)	21 (18.1)	201 (16.4)	0.60
Use of balloon catheter (%)	94 (81.0)	969 (79.0)	0.72
Wire-guided cannulation (%)	13 (11.2)	130 (10.6)	0.88
Female (%)	55 (47.4)	589 (48.0)	0.92
PT-INR [mean (SD)]	1.2 (0.90)	1.2 (0.85)	0.93
Antithrombotic treatment	32 (27.6)	342 (27.9)	1.0
Billroth-1 reconstruction (%)	3 (2.6)	31 (2.5)	1.0
Presence of gallstones (%)	75 (64.7)	787 (64.1)	1.0
Successful biliary cannulation (%)	115 (99.1)	1209 (98.5)	1.0
Large stones (> 10 mm) (%)	22 (19.0)	234 (19.1)	1.0

CBDS: Common bile duct stones; CBD: Common bile duct; ERCP: Endoscopic retrograde cholangiopancreatography; PT- EST: Endoscopic sphincterotomy; EPBD: Endoscopic papillary balloon dilation; EPLBD: Endoscopic papillary large balloon dilation; PGW: Pancreatic guidewire; NSAIDs: Nonsteroidal anti-inflammatory drugs; INR: Prothrombin time-international normalized ratio.