Optimization of biliary drainage in inoperable distal malignant strictures

Table 1 Patient characteristic among different groups

Number	Stent type, n = 70, n (%)			P value
	HCMS	FCMS	UMS
Gender				0.86
Male	45 (64.3)	46 (65.7)	48 (68.6)
Female	25 (33.7)	24 (34.3)	22 (31.4)
Age, median (range)	67 (39-84)	65 (45-82)	64 (42-83)	0.37
Cholecystectomy	16 (22.9)	17 (24.3)	17 (24.3)	0.97
Cause of distal biliary obstruction				0.99
Cancer pancreas	47 (67.1)	48 (68.6)	46 (65.7)
Distal cholangiocarcinoma	9 (12.9)	10 (14.3)	12 (17.2)
Gallbladder cancer	5 (7.1)	4 (5.7)	5 (7.1)
Ampullary cancer	9 (12.9)	8 (11.4)	7 (10.0)
Laboratory investigations, mean ± SD
Serum total bilirubin, mg/dL	15 ± 8.7	14.5 ± 5.6	16.1 ± 7.7	0.43
Serum direct bilirubin, mg/dL	13 ± 6.4	12.9 ± 4.1	13.2 ± 6.8	0.95
SGPT, UI/L	112 ± 90	110.7 ± 96.5	120.2 ± 90.3	0.80
SGOT, UI/L	146 ± 110.2	129.3 ± 106.2	142.4 ± 112.1	0.64
Albumin	4.1 ± 1.3	3.9 ± 1.4	3.8 ± 1.6	0.46
INR	1.3 ± 0.2	1.2 ± 0.2	1.2 ± 0.2	0.94
Imaging
Liver metastasis	2 (2.9)	1 (1.4)	1 (1.4)	0.78
PVT	1 (1.4)	1 (1.4)	2 (2.9)	0.78
Ascites	1 (1.4)	2 (2.9)	1 (1.4)	0.78
Clinical presentation
Jaundice	57 (81.4)	55 (78.6)	55 (78.6)	0.89
Pain	34 (48.6)	31 (44.3)	34 (48.6)	0.84
Fever	9 (12.9)	8 (11.4)	9 (12.9)	0.96
Itching	16 (22.9)	15 (21.4)	18 (25.7)	0.83
Anorexia	27 (38.6)	26 (37.1)	20 (28.6)	0.41
Weight loss	44 (62.9)	42 (60.0)	45 (64.3)	0.87
Cholangitis	12 (17.1)	10 (14.3)	13 (18.6)	0.79
Operative time, time passed from selective cannulation till the end of procedure	4.5 ± 2.5 min	4 ± 3 min	5 ± 3.5 min	0.15
X-ray dose, time passed from selective cannulation till the end of procedure	2 ± 1 min	2 ± 1.5 min	2 ± 1 min	NA
Antibiotic				0.87
No	44 (62.9)	42 (60.0)	45 (64.3)
Yes	26 (37.1)	28 (40.0)	25 (35.7)
Previous chemotherapy				0.9
No	59 (84.3)	58 (82.9)	57 (81.4)
Yes	11 (15.7)	12 (17.1)	13 (18.6)
Radiotherapy				0.36
No	69 (98.6)	70 (100)	68 (97.1)
Yes	1 (1.4)	0 (0.0)	2 (2.9)
Post-stenting chemotherapy				0.91
No	55 (78.6)	56 (80.0)	57 (81.4)
Yes	15 (21.4)	14 (20.0)	13 (19.6)

HCMS: Half covered metal stent; FCMS: Fully covered metal stent; INR: International standard ratio; PVT: Production verification test; SGOT: Serum glutamic-oxaloacetic transaminase; SGPT: Serum glutamic-pyruvic transaminase; UMS: Uncovered metal stent.

Table 2 Patient outcomes among different groups

	Half and half stents, n (%)	Fully covered stents, n (%)	Un-covered stents, n (%)	P value
Successful deployment	70/70 (100)	70/70 (100)	70 /70 (100)
Procedure related complications
Major adverse events and or mortality	0	0	0	00
pancreatitis	6 (8.6 )	5 (7.1)	5 (7.1)	0.93
Minor bleeding	4 (5.7)	3 ( 4.3)	5 (7.1)	0.77
Post-ERCP complications
Occlusion	13 (18.6)	12 (17.1)	11 (15.7)	0.9
Early stent adverse effect, within 1 mo	1 (1.4)	4 (5.7)	1 (1.4)	0.21
Sludge formation	9 (12.9)	7 (11.1)	1 (1.4)	0.04
Tumor Ingrowth	0 (0.0)	0 (0.0)	10 (14.3)	0.00003
Tumor Overgrowth	4 (5.7)	5 (7.1)	0 (0.0)	0.09
Cholangitis due to stent occlusion	7 (10.0)	8 (11.4)	7 (10.0)	0.95
Cholecystitis	0 (0.0)	4 (5.7)	0 (0.0)	0.02
Migration	0 (0.0)	6 (8.6)	0 (0.0)	0.002
Stent patency in d, median (95%CI)	614 (390.6-780.1)	256.0 (167.5-315.4)1,2	536 (323.1-743.9)	0.02
Follow-up in d, median (range)	112 (5-613)	109 (7-621)	108 (7-541)	0.82
Overall survival in d, median (95%CI)	129 (96.8-167.1)	114.0 (92.7 -165.4)	119.0 (89.9-160.1)	0.20

¹Tamhane post-hoc P value < 0.05 between half and half stents and fully covered stents.

²Tamhane post-hoc P value < 0.05 between uncovered stents and fully covered stents. CI: Confidence interval; ERCP: Endoscopic retrograde cholangio-pancreatography.