Evaluation of fully covered self-expanding metal stents in benign biliary strictures and bile leaks

Table 1 Studies reporting placement of covered metal stent in benign biliary strictures and bile leaks

Ref.	No. of patients/No. stents	BBS or bile leaks	Etiology	Stent type	Time to removal	Results (success rate )	Complications
Benign biliary strictures
Deviere et al[18]	20/20	BBS	CP	Wallstent FCSEMS	NA1	90%	Epithelial hyperplasia (2)
Cantù et al[19]	14/14	BBS	CP	pCSEMS	21 mo (median)	37.5% at 30-mo fu	Cholestasis (7), cholangitis (5), duodenal migration (2), cholecystitis (1)
Kuo et al[20]	3/4	BBS	OLT	FCSEMS	32 d (median)	100%	Septicemia (1), misplacement (1)
Kahaleh et al[2]	79/79	BBS	CP, OLT, BC, INF, surgical	pCSEMS	4 mo (median)	90% ITT 75%	Migrations (11)
Cahen et al[21]	6/6	BBS	CP	FCSEMS	3-6 mo (median)	66%	Migration (2), recurrent stricture (1)
Mahajan[3]	44/44	BBS	CP, gallstone related, OLT, AP, PSC	FCSEMS	3.3 mo (median)s	83% 77% ITT (3 patients died)	Post ERCP pancreatitis (1), mucousal ulceration and bleeding (1)
Garcia-Cano[22]	20/20	BBS	Biliary fistula, perforation of papilla, to remove uncovered stents, benign strictures, CBD stones	Wallstent FCSEMS	132 d (median)	70%	Pancreatitis (3)
Sauer et al[23]	19/19	BBS and bile leaks	Liver transplant	Wallflex	11.7 wk (mean)	79%	Proximal migration (1), distal migration (5), occlusion (1), de novo stricture (2)
Bile leaks
Wang et al[24]	13	Complex bile leaks	Chole and OLT	Viabil FCSEMS	103 d	85% ITT	Mucousal ulcerations (4), de novo choledocholithiasis/ luminal debris (10), strictures (2)
Sandha et al[8]	97	High grade leaks	Chole	FCSEMS	42 d	100%	Post ERCP pancreatitis (2), duodenal perforation (1)
Kahaleh et al[1]	16/16	Bile leaks	Chole, OLT	Wallstent FCSEMS	3 mo	93%	Stent migration (2)
Sauer et al[23]	19/19	BBS and bile leaks	Liver transplant	Wallflex	11.7 wk (mean)	79%	Proximal migration (1), distal migration (5), occlusion (1), de novo stricture (2)

¹Stents not extracted in the study. OLT: Orthotopic liver transplant; Chole: Cholecystectomy; AP: Autoimmune pancreatitis; PSC: Primary sclerosing cholangitis; ITT: Intent to treat; pCSEMS: Partially covered self-expanding metal stent; FCSEMS: Fully covered self-expanding metal stent; BBS: Benign biliary strictures; CP: Cholangiopancreatography.

Table 2 Patient characteristics and demographics

Case No.	Age, yr	Sex	Etiology	Location	FCSEMS (mm), type	Complications	Duration of stenting (d)	Follow-up after removal (d)	Results
Benign biliary strictures
1	47	M	Biliary anastomosis/Whipple	Choledocho-duodenal anastomosis	10 mm × 0 mm Viabil	None	89	1435	Patent
2	77	F	Cholecystectomy	Distal CBD	10 mm × 10 cm wallstent	None	92	1210	Patent
3	36	F	Cholelithiasis	Distal CBD	10 mm × 6 cm Viabil	None	37	1138	Patent
4	51	F	Cholelithiasis	Distal CBD	10 mm × 6 cm Viabil	None	161	1131	Patent
5	73	M	Cholecystectomy	Right intrahepatic duct	10 mm × 10 cm Viabil	Solid debris in lumen	160	1112	Patent
6	76	F	Cholecystectomy	H-J anastomosis	8 mm × 6 cm Viabil	None	29	55	Patent
7	27	F	Cholecystectomy	H-J anastomosis	10 mm × 4 cm Viabil	None	42	176	Patent
8	47	F	Compression by hepatic artery	CHD	80 mm × 8 cm wallstent	None	35	302	Patent
9	36	F	Cholecystectomy	CBD	10 mm × 80 mm Viabil	Migration	27	463	Not patent
10	45	F	Chronic pancreatitis/ cholecystectomy	Distal CBD	10 mm × 10 cm Viabil	None	63	36	Patent
11	42	F	Pancretitis and pancreatic head necrosis	Distal CBD	10 mm × 6 cm wallstent	Recurrent cholangitis (n = 2), migration	199	122	Patent
12	35	M	Cholecystectomy	Distal CBD	10 mm × 8 cm Viabil	Abd pain following day of stent placement; repeat ERCP showed residual bile duct stones	57	41	Patent
Bile leaks
13	75	F	Cholecystectomy	Bile leak (high grade); complex	10 mm × 80 mm Viabil	None	99	1364	Sealed
14	49	F	Cholecystectomy	Bile Leak (high grade)	10 mm × 10 cm Viabil	None	92	1294	Sealed
15	30	F	Cholecystectomy	Bile leak (low grade); complex	10 mm × 80 mm Viabil	Occluded stent after lost to follow-up (eight and a half months)	251	1007	Sealed
16	64	M	Cholecystectomy	Bile leak (high grade)	8 mm × 8 cm Viabil	None	62	575	Sealed
17	50	M	Cholecystectomy	Bile leak (low grade)	10 mm × 80 mm Viabil	Hepatic abscess and Sepsis	48	28	Sealed

M: Male; F: Female; FCSEMS: Fully covered self-expandible metallic stents; Chole: Cholecystectomy; CBD: Common bile duct; H-J: Hepaticojejunostomy; CHD: Common hepatic duct; ERCP: Endoscopic retrograde cholangiopancreatography.