Self-expandable metal stents for malignant gastric outlet obstruction: A pooled analysis of prospective literature

Table 1 Literature table

Ref.	Design, patients,indication	No. of stents1, biliary obstruction	Stent type	Technicalsuccess	ClinicalSuccess, definition	Adverse events	Stent dysfunction	Stent patency,median (range)	Survival, follow-up,median (range)
Maetani et al[15] 2014 Japan	RCT, n = 62 GC: n = 27 PC: n = 26 BDC: n = 7 OT: n = 2	No. of stents: 1: n = 58 2: n = 4 Biliary drainage: Yes: n = 24 No: n = 38	UCSEMS: -Niti-S PCSEMS: -Niti-S Comvi	100% (62/62)	90.3% (56/62) -UCSEMS: 93.5% (29/31) -PCSEMS: 87.1% (27/31) ≥ 1 grade of improvement in GOOSS at any visit compared to baseline	Perforation: 1.6% (1/62) -PCSEMS: 3.2% (1/31) Major bleeding: 1.6% (1/62) -UCSEMS: 3.2% (1/31)	Overall: 22.6% (14/62) -UCSEMS: 29.0% (9/31) -PCSEMS: 16.1% (5/31) Re-obstruction: 9.7% (6/62); -UCSEMS: 19.4% (6/31) -PCSEMS: 0% (0/31) Migration: 4.8% (3/62) -UCSEMS: 3.2% (1/31) -PCSEMS: 6.5% (2/31) Fracture: 4.8% (3/62) -UCSEMS: 6.5% (2/31) -PCSEMS: 3.2% (1/31) Insufficient expansion: 3.2% (2/62) -UCSEMS: 0% (0/31) -PCSEMS: 6.5% (2/31)	PCSEMS: 68 d UCSEMS: 88 d (P = 0.70)	PCSEMS: 73 d UCSEMS: 93 d (P = 0.34) FU: 83.5 d; until death
Shi et al[16] 2014 China	RCT, n = 65 GC: n = 65	No. of stents: 1: n = 65 Biliary obstruction: NR	UCSEMS: -Micro-Tech PCSEMS: -Micro-Tech (tailored cup- or funnel-shaped)	96.9% (63/65) -UCSEMS: 96.9% (31/32) -PCSEMS: 97.0% (32/33)	93.7% (59/63) -UCSEMS: 93.5% (29/31) -PCSEMS: 93.8% (30/32) Resolution of symptoms and the ability to restart a low residue diet after stent placement	Mild bleeding: 20% (13/65) -UCSEMS: 6.3% (2/32) -PCSEMS: 33.3% (11/33) Mild abdominal pain: 21.5% (14/65) -UCSEMS: 3.1% (1/32) -PCSEMS: 39.4% (13/33)	Overall: 18.5% (12/65) -UCSEMS: 25% (8/32) -PCSEMS: 12.1% (4/33) Re-obstruction: 12.3% (8/65) -UCSEMS: 21.9% (7/32) -PCSEMS: 3.0% (1/33) Migration: 3.1% (2/65) -UCSEMS: 0% -PCSEMS: 6.1% (2/33) Food impaction: 3.1% (2/65) -UCSEMS: 3.1% (1/32) -PCSEMS: 3.0% (1/33)	NR	Tailored PCSEMS: mean 231 (30-387) d Standard UCSEMS: mean 212 (43-267) d FU: until death
Tringali et al[1] 2014 Italy, Netherlands, Australia, Czech Republic, Canada, United States	Pros, n = 108 PC: n = 58 GC: n = 14 BDC: n = 7 GBC: n = 7 DC: n = 5 APC: n = 3 OT: n = 14	No. of stents: 1: n = 106 2: n = 2 Biliary obstruction: Yes: n = 56 No: n = 52	UCSEMS: -Evolution	99.1% (107/108)	84.5% (82/97) Relief of symptoms and/or improvement of oral intake at 14 d	Overall: 32.4% (35/108), including 19.4% (21/108) stent-related Perforation: 1.9% (2/108) Bleeding: 4.6% (5/108) No intervention required Abdominal pain: 1.9% (2/108) Other GI events: 15.7% (17/108)	Overall: 17.6% (19/108) Re-obstruction: 15.7% (17/108) Migration: 1.9% (2/108)	Estimated patency rates: -At 14 d: 94.6% (88/93) -At 60 d: 86.2% -At 180 d: 63.4%	Patients who completed 6 mo follow-up (11/108): 182 (178-195) d Patients who died before 6 mo follow-up: 52 (9-180) d FU: until 6 mo, death or re-intervention
Shi et al[17] 2013 China	Pros, n = 37 GC: n = 37	No. of stents: 1: n = 35 2: n = 2 Biliary obstruction: NR	PCSEMS: -Micro-Tech (cup- or funnel-shaped)	97.3% (36/37)	94.4% (34/36) Relief of obstructive symptoms	Mild bleeding: 40.5% (15/37) Major hemorrhage: 2.7% (1/37) Abdominal pain: 37.8% (14/37) Perforation: 0%	Overall: 5.4% (2/37) Food impaction: 5.4% (2/37) Migration: 0% Re-obstruction: 0%	NR	Mean 232 (28-387) d FU: until death
van den Berg et al[18] 2013 Netherlands	Pros, n = 46 PC: n = 25 GC: n = 5 BDC: n = 7 DC: n = 3 GBC: n = 1 OT: n = 5	No. of stents: 1: n = 43 2: n = 3 Biliary drainage: Yes: n = 34 No: n = 12	UCSEMS: -Evolution	89.1% (41/46)	71.7% (33/46) Improvement of GOOSS of ≥ 1 point and/or relief of symptoms after 1 wk	Overall: 56.5% (26/46) Procedure-related: -Perforation: 2.2% (1/46) -Pancreatitis: 2.2% (1/46) -Pain: 2.2% (1/46) -Cholangitis: 2.2% (1/46) Non procedure-related: -Acute abdomen: 2.2% (1/46) -Cholangitis: 13.0% (6/46) -Jaundice: 4.3% (2/46) -Anemia: 8.7% (4/46) -Pneumonia: 2.2% (1/46) -CVA: 6.5% (3/46) -Ascites: 4.3% (2/46) -Motility disorder: 10.9% (5/46)	Overall: 30.4% (14/46) Re-obstruction: 19.6% (9/46) Stent compression: 4.3% (2/46) Migration: 4.3% (2/46) Food impaction: 2.2% (1/46)	67% for up to 395 d, accounting for death unrelated to stent	87 (IQR 35-237) d FU: until death
Costamagna et al[2] 2012 Italy, Czech Republic, South Africa, Canada, Sweden, Brazil, France, Germany, Finland, Spain	Pros, n = 202 PC: n = 104 GC: n = 37 DC: n = 18 BDC: n = 12 GBC: n = 12 APC: n = 2 OT: n = 17	No. of stents: 1: n = 192 2: n = 10 Biliary drainage: Yes: n = 127 No: n = 75	UCSEMS: -WallFlex	98.0% (198/202)	91% (177/195) Relief of obstruction as measured by oral intake	Overall: 20.3% (41/202) Transient periprocedural symptoms: 3.5% (7/202) Bleeding: 3.0% (6/202) -Major: 2.0% (4/202) -Self-limiting: 1.0% (2/202) Perforation: 0.5% (1/202)	Re-obstruction: 12.4% (25/202) Migration: 1.5% (3/202) Food impaction: 0.5% (1/202)	Maintaining GOOS score of 2-3 (n = 149): 91 d (95%CI: 87-182)	Survival rate at 9 mo: 28.2% FU: until 9 mo
Isayama et al[19] 2012 Japan	Pros, n = 50 PC: n = 26 GC: n = 14 BDC: n = 9 OT: n = 1	No. of stents: NR Biliary obstruction: Yes: n = 30 No: n = 20	PCSEMS: -ComVi Niti-S (modified)	100% (50/50)	90% (45/50) Relief of symptoms or improvement in GOOSS after 3 d	Cholangitis: 2% (1/50) Mild pancreatitis: 2% (1/50) Minor perforation: 2% (1/50)	Overall: 18% (9/50) Re-obstruction: 10% (5/50) Stent migration: 6% (3/50) Insufficient expansion: 2% (1/50)	Mean ± SD: 149.8 ± 8.9 d	106 d FU: NR
Moura et al[20] 2012 Brazil	Pros, n = 15 PC: n = 9 GC: n = 3 BDC: n = 1 OT: n = 2	No. of stents: NR Biliary drainage: Yes: 8 No: 7	UCSEMS: -WallFlex	100% (15/15)	80% (12/15) Improvement of GOOSS at 15 d	Removal of foreign body: 7% (1/15)	Re-obstruction: 13% (2/15) Migration: 13% (2/15)	Mean time to first failure to maintain GOOS 2-3: 2.35 mo	NR FU: until 180 d
Dolz et al[21] 2011 Spain	Pros, n = 77 GC: n = 29 PC: n = 20 DC: n = 5 GBC: n = 4 BDC: n = 3 APC: n = 3 OT: n = 6 Unk: n = 7	No. of stents: NR Biliary obstruction: NR	UCSEMS: -WallFlex -Wallstent -Ultraflex	92.2% (71/77)	81.7% (58/71) GOOSS 2-3 post-stenting	Pneumonia: 1.4% (1/71) Central catheter infection: 1.4% (1/71) Self-limiting bleeding: 7.0% (5/71) Late perforation: 2.8% (2/71) Intense pain: 2.8% (2/71)	Re-obstruction: 14.1% (10/71) Insufficient expansion: 4.2% (3/71)	NR	91 (9-552) d FU: NR
Kim et al[22] 2011 South Korea	Pros, n = 50 GC: n = 31 PC: n = 11 BDC: n = 6 GBC: n = 2	No. of stents: NR Biliary drainage: Yes: n = 17 No: n = 33	PCSEMS: -Niti-S Comvi	100% (50/50)	88% (44/50) Ability to tolerate oral food intake without vomiting	Hyperamylasemia: 2% (1/50) Obstructive jaundice: 10% (5/50)	Re-intervention rate: 28% (14/50) Stent migration: 10% (5/50) Re-obstruction: 8% (4/50) Stent compression: 10% (5/50)	Mean 92 (4-238) d	Mean 110 (30-290) d FU: until death
van Hooft et al[23] 2011 Netherlands	Pros, n = 52 PC: n = 32 GC: n = 7 BDC: n = 10 APC: n = 1 DC: n = 1 OT: n = 1	No. of stents: 1: n = 45 2: n = 7 Biliary obstruction: NR	UCSEMS: -Niti-S D-Weave	96.2% (50/52)	76.9% (40/52) Relief of symptoms or improvement of GOOSS after 1 wk	Overall complications: 23.1% (12/52) Procedure-related: -Pain: 7.7% (4/52) -Cholangitis: 1.9% (1/52) Non procedure-related: -Anemia: 3.8% (2/52) -Pneumonia: 1.9% (1/52) -Ascites: 1.9% (1/52) -Gastroenteritis: 1.9% (1/52) -Peritonitis carcinomatosis: 1.9% (1/52) -Bacteremia: 1.9% (1/52)	Overall: 25% (13/52) Re-obstruction: 21.2% (11/52) Migration: 3.8% (2/52)	75% for up to 190 d, accounting for death unrelated to stent	82 (IQR 31-135) d FU: until death
Jeurnink et al[9], 2010 Netherlands	RCT, n = 21 PC: n = 15 GC: n = 2 DC: n = 3 OT: n = 1	No. of stents: 1: n = 17 2: n = 4 Biliary drainage: Yes: n = 12 No: n = 9	UCSEMS: -WallFlex	95.2% (20/21)	85.7% (18/21); persistent obstruction within 4 wk in 3/21	Bacterial infection: 4.8% (1/21) Delayed gastric emptying: 14.3% (3/21) Jaundice post stent: 19.0% (4/21) Cholangitis: 4.8% (1/21)	Overall: 19.0% (4/21) Re-obstruction: 9.5% (2/21) Migration: 4.8% (1/21) Food obstruction: 9.5% (2/21) Re-intervention rate: 33% (7/21)	NR	56 d FU: until death
Kim et al[24] 2010 South Korea	RCT, n = 80 GC: n = 80	No. of stents: NR Biliary obstruction: NR	PCSEMS: -Niti-S pyloric -Niti-S Comvi UCSEMS: -Wallstent -WallFlex	100% (80/80)	92.5% (74/80) -PCSEMS: 95% (38/40) -UCSEMS: 90% (36/40) Relief of symptoms or improvement of GOOSS at 3 d	Perforation by migrated stent: 1.5% (1/67) -PCSEMS: 3.2% (1/31) Intestinal obstruction by migrated stent fragment after fracture: 1.5% (1/67) -PCSEMS: 3.2% (1/31)	Re-obstruction: 25.4% (17/67) -PCSEMS: 3.2% (1/31) -UCSEMS: 44.4% (16/36) Migration: 19.4% (13/67) -PCSEMS: 32.3% (10/31) -UCSEMS: 8.3% (3/36) Fracture: 4.5% (3/67) -PCSEMS: 9.7% (3/31) Stent collapse: 1.5% (1/67) -PCSEMS: 3.2% (1/31)	PCSEMS: 14 wk (95%CI: 8.9-19.1) UCSEMS: 13 wk (95%CI: 9.5-16.5)	PCSEMS: 26 wk (95%CI: 11-41) UCSEMS: 19 wk (95%CI: 10-28) FU: until 8 wk
Maetani et al[25] 2010 Japan	Pros, n = 53 GC: n = 29 PC: n = 14 BDC: n = 5 OT: n = 5	No. of stents: 1: n = 44 2: n = 9 Biliary drainage: Yes: n = 17 No: n = 36	UCSEMS: -Niti-S	98.1% (52/53)	94.3% (50/53) Ability to tolerate oral intake without vomiting	Procedure-related perforation: 1.9% (1/53) Obstructive jaundice: 1.9% (1/53) Major bleeding: 1.9% (1/53)	Overall: 18.9% (10/53) Insufficient expansion: 3.8% (2/53) Re-obstruction: 13.2% (7/53) Food impaction: 1.9% (1/53) Fracture: 1.9% (1/53) Re-intervention rate: 20.8% (11/53)	NR	88 d FU: until death
Shaw et al[26], 2010 South Africa	Pros, n = 70 GC: n = 19 PC: n = 34 GBC: n = 5 DC: n = 2 BDC: n = 3 OT: n = 7	No. of stents: NR Biliary drainage: Yes: n = 35 No: n = 35	UCSEMS: -WallFlex	92.9% (65/70)	88.6% (62/70) Resumption of intake that enabled the patient to return home independent of nutritional support	Minor bleeding: 2.9% (2/70) Perforation: 0%	Overall: 7.1% (5/70) Re-obstruction: 4.3% (3/70) Insufficient expansion: 1.4% (1/70) Stent migration: 1.4% (1/70)	NR	1.8 (0.1-19) mo FU: 54 (range 1-570) d; until death
Havemann et al[27] 2009 Denmark	Pros, n = 45 PC: n = 30 GC: n = 5 OT: n = 10	No. of stents: NR Biliary drainage: Yes: n = 11 No: n = 34	UCSEMS: -Hanaro	91.1% (41/45)	63.4% (26/41) Improvement in GOOSS by ≥ 1 point	Procedure-related perforation: 4.4% (2/45) Biliary obstruction: 17.8% (8/45)	Re-obstruction: 8.9% (4/45) Migration: 6.7% (3/45) Re-intervention rate: 13.3% (6/45)	NR	Mean 121 (95%CI: 62-181) d FU: NR
Lee et al[5] 2009 South Korea	Pros, n = 154 GC: n = 122 PC: n = 19 GBC: n = 3 BDC: n = 3 APC: n = 4 DC: n = 2 OT: n = 1	No. of stents: NR Biliary obstruction: NR	UCSEMS: -Niti-S PCSEMS: -Niti-S	100% (154/154)	97.4% (150/154) -PCSEMS: 98.6% (69/70) -UCSEMS: 96.4% (81/84) Relief of vomiting and resumption of diet	No procedure-related complications	Migration: 7.8% (12/154) -PCSEMS: 17.1% (12/70) -UCSEMS: 0% Re-obstruction: 13.6% (21/154) -PCSEMS: 7.1% (5/70) -UCSEMS: 19.0% (16/84) Re-intervention rate: 17.5% (27/154) -PCSEMS: 21.4% (15/70) -UCSEMS: 14.3% (12/84)	UCSEMS: 73 (95%CI: 44-102) d PCSEMS: 75 (95%CI: 47-134) d	UCSEMS: 108 (95%CI: 60-151) d PCSEMS: 115 (95%CI: 80-156) d FU: until death
Piesman et al[28] 2009 United States	Pros, n = 43 PC: n = 21 GC: n = 8 BDC: n = 3 GBC: n = 1 OT: n = 9 Unk: n = 1	No. of stents: 1: n = 39 2: n = 4 Biliary drainage: Yes: n = 23 No: n = 20	UCSEMS: -WallFlex	95.3% (41/43)	81.4% (35/43) GOOSS increase of ≥ 1 point	Duodenal perforation: 4.7% (2/43) Vomiting: 9.3% (4/43) Cholangitis: 2.3% (1/43) Hemorrhage: 2.3% (1/43) -Endoscopy performed Nausea: 2.3% (1/43) Sepsis: 2.3% (1/43)	Overall: 18.6% (8/43) Re-obstruction: 9.3% (4/43) Malposition: 2.3% (1/43) Stent collapse: 2.3% (1/43) Incomplete expansion: 4.7% (2/43) Occlusion by jejunal wall: 2.3% (1/43) Migration: 0%	GOOS score increase of ≥ 1 until death or end of follow-up: 45% (95%CI: 27-74)	49 d; At 24 wk: 44.1% (19/43) FU: until 24 wk
Van Hooft et al[29] 2009 Netherlands	Pros, n = 51 PC: n = 35 GC: n = 2 BDC: n = 3 DC: n = 3 GBC: n = 2 APC: n = 1 OT: n = 5	No. of stents: 1: n = 48 2: n = 3 Biliary drainage: Yes: n = 38 No: n = 13	UCSEMS: -WallFlex	98.0% (50/51)	84.3% (43/51) Relief of symptoms or improvement of GOOSS after 1 wk	Motility dysfunction: 3.9% (2/51) Intermittent pain: 3.9% (2/51) Cholangitis: 5.9% (3/51) Major bleeding: 3.9% (2/51)	Re-obstruction: 11.8% (6/51) Migration: 2.0% (1/51)	307 d; 75% functional at 135 d, 25% functional at 470 d	62 d; 75% alive at 35 d, 25% alive at 156 d FU: until death

¹Number of enteral stents inserted at the initial procedure. Pros: Prospective; Retro: Retrospective; RCT: Randomized controlled trial; GC: Gastric cancer; PC: Pancreatic cancer; BDC: Bile duct cancer; GBC: Gallbladder cancer; APC: Ampullary cancer; DC: Duodenal cancer; OT: Other malignancies; UCSEMS: Uncovered self-expandable metal stent; PCSEMS: Partially covered self-expandable metal stent; FU: Follow-up; GOOSS: Gastric outlet obstruction severity score; NR: Not reported; IQR: Interquartile range; GI: Gastrointestinal; CVA: Cerebrovascular accident.