Randomized trial in malignant biliary obstruction: Plastic vs partially covered metal stents

Table 1 Patient characteristics at baseline

Characteristic		Partially covered SEMS (n = 42)	10-French polyethylene plastic stent (n = 43)	P value
Gender (male)		51.2%	50.0%	0.9119
Age (yr)		70.8 ± 12.9	73.3 ± 10.7	0.3896
Co-morbidities:	Cardiovascular	53.7%	47.5%	0.5676
	Respiratory	22.0%	20.0%	0.8209
	Neurologic	19.5%	22.5%	0.7343
	GI, liver, biliary	75.6%	77.5%	0.8362
	Renal, urinary	15.0%	30.0%	0.0982
	Musculoskeletal	25.0%	35.0%	0.3148
	Endocrine	47.5%	30.0%	0.0976
Cholestatic symptoms		97.5%	100.0%	0.2968
	Jaundice	85.4%	97.5%	0.0453
	Clay-colored stools	36.6%	52.5%	0.1404
Abdominal pain	Abdominal pain	53.7%	40.0%	0.2056
Pruritus		51.2%	50.0%	0.9119
Dark urine		75.6%	75.0%	0.9489
Fever	Fever	9.8%	5.0%	0.3972
Constitutional symptoms
	Weight Loss	73.2%	47.5%	0.0155
	Anorexia	51.2%	50.0%	0.9119
Obstruction location	Papilla	2.78%	7.9%	0.2951
	Distal common bile duct	72.2%	47.4%	0.0198
	Mid common bile duct	22.2%	39.5%	0.0845
	Proximal common bile duct	2.8%	5.3%	0.5595
Type of primary tumor	Ampullary carcinoma	2.6%	7.5%	0.3036
	Cholangiocarcinoma	0.0%	5.0%	0.1422
	Gallbladder adenocarcinoma	2.6%	2.5%	0.9767
	Metastatic Cancer	10.3%	7.5%	0.6501
	Pancreatic adenocarcinoma	69.2%	67.5%	0.8662
	Other	0.0%	2.5%	0.3024
	Unknown	15.4%	7.5%	0.2519
Metastat. cancer prim. location	Colon	28.6%	0.0%	0.0002
	Lung	28.6%	20.0%	0.355
	Other	42.9%	80.0%	0.0004
Tumor stage	T1	4.0%	19.2%	0.0292
	T2	32.0%	11.5%	0.0217
	T3	16.0%	42.3%	0.0077
	T4	48.0%	26.9%	0.0443
Nodes	N0	36.4%	61.9%	0.0187
	N1	63.6%	38.1%	0.0187
Metastatic tumor	M0	29.2%	36.0%	0.5038
	M1	70.8%	64.0%	0.5038
Chemotherapy or radiation		11.1%	8.82%	0.7255
Laboratory data	Alkaline phosphatase (IU/L)	630.5 ± 347.7	532.7 ± 331.4	0.1486
	Bilirubin (mg/dL)	9.56 ± 6.99	11.33 ± 7.82	0.3082
	Hematocrit	43.97% ± 50.36%	37.06% ± 5.95%	0.3280
	Hemoglobin (g/dL)	12.01 ± 1.63	12.39 ± 2.09	0.3305
	INR	1.17 ± 0.19	1.25 ± 0.36	0.5922
	AST (IU/L)	168.64 ± 98.34	191.26 ± 149.25	0.6687
	ALT (IU/L)	240.03 ± 178.35	265.03 ± 240.48	0.8926
Karnosky performance scores		81.8 ± 10.8	82.0 ± 12.03	0.9151

SEMS: Self-expandable metal stent; INR: International normalized ratio; AST: Aspartate aminotransferase; ALT: Alkaline phosphatase.