Table 1.

Covered versus uncovered self-expandable metal stents in malignant distal biliary obstruction

Ref.	Study design; country	Total number subjects	Number of SEMS Placed, CSEMS vsUSEMS	Recurrent biliary obstruction; CSEMS vsUSEMS, n (%)	Stent patency CSEMS vsUSEMS, d	Procedure related adverse events, CSEMS vsUSEMS, % (n = #)
Sakai et al[13], 2021	Multicenter randomized control trial; Japan	92	44 vs 48	10 (22.7%) vs 21 (43.8%), P = 0.0467	455 vs 301, P = 0.0112	6.8% (2 cholangitis, 1 cholecystitis) vs 8.3% (2 pancreatitis, 2 cholangitis), P = 0.549
Conio et al[14], 2018	Multicenter randomized control trial; Italy	158	78 vs 80	12 (16.7%) vs 10 (13.2%), P = 0.65	240 vs 541, P = 0.031	18% (6 cholangitis, 2 cholecystitis, 5 migrations) vs 7.9% (6 cholangitis), P = 0.061
Yang et al[15], 2015	Single center randomized control trial; South Korea	103	51 vs 52	17 (33.3%) vs 15 (28.8%), P = 0.623	395 vs 365, P = 0.467	17.6% (5 cholecystitis, 3 pancreatitis, 1 cholangitis) vs 9.6% (3 cholecystitis, 2 cholangitis), P = 0.378
Lee et al[16], 2013	Single center randomized control trial; South Korea	40	20 vs 20	10 (50%) vs 4 (20%), P = 0.047	207 vs 413, P = 0.041	5% (1 cholecystitis) vs 0%, NS
Lee et al[17], 2014	Retrospective, single center; USA	749	171 vs 578	33 (19%) vs 123 (21%), P < 0.001	468 vs 799, P = 0.61	8.2% (10 pancreatitis, 4 cholangitis) vs 6.4% (6 pancreatitis, 3 cholecystitis, 28 cholangitis), P = 0.20
Kitano et al[18], 2013	Multicenter randomized control trial; Japan	120	60 vs 60	14 (23%) vs 22 (36%), P = 0.08	583 vs 314, P = 0.019	3.3% (1 pancreatitis, 1 cholecystitis) vs 3.3% (2 cholecystitis), NS
Telford et al[19], 2010	Multicenter randomized control trial; Canada	129	68 vs 61	20 (29%) vs 11 (18%), NS	357 vs 711, P = 0.530	4.4% (3 cholecystitis) vs 6.6% (3 cholecystitis, 1 pancreatitis), P = 0.046
Kullman et al[20], 2010	Multicenter randomized control trial; Sweden	379	188 vs 191	47 (25%) vs 45 (24%), P > 0.50	154 vs 199, P = 0.326	7.5% (2 cholecystitis,3 pancreatitis, 8 cholangitis, 1 perforation) vs 10.5% (2 cholecystitis,4 pancreatitis, 12 cholangitis, 1 perforation, 1 hemorrhage), P = 0.370
Isayama et al[21], 2004	Single center randomized control trial; Japan	112	57 vs 55	8 (14%) vs 21 (38.2%), P < 0.001	304 vs 161, P < 0.05	12.3% (5 pancreatitis, 2 cholecystitis) vs 5.5% (1 pancreatitis, 2 hemorrhage), NS

NS: Not significant; USA: United States.