Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature

Table 4 Literature on self-expandable stent placement for benign esophageal leaks, perforations and fistulae

Ref.	Study design	Patients	Stent type, technical success (%) and time to removal	Additional sepsis-related procedures, follow-up	Complications and mortality	Successfulstent removal	Clinical success
Dua et al[29] 2014	Pro- and retrospect	Patients treated with a non-foreshortening FC SEMS for benign esophageal leaks: n = 6 1 Postsurgical leaks: n = 5 2 Esophagopericardial fistula: n = 1 Single stent: 83% (5/6) Multiple stents: 17% (1/6)	FC SEMS: 100% (7/7) Median time to removal: 50 (49-56) d	Unknown FU: unknown	Minor complications: Pneumoperitoneum during endoscopy secondary to air insufflation: 17% (1/6) Stent migration: 17% (1/7) Mortality rate: 33.3% (2/6) - cerebral embolism: 16.7% (1/6) - sepsis-related: 16.7% (1/6)	FC SEMS: 100% (4/4)	Overall: 67% (4/6) -Postsurgical leaks: 80% (4/5) -Fistula: 0% (0/1)
El Hajj et al[30] 2014	Retrospect	Patients with attempted stent placement for esophageal leaks, fistulae and perforations: 1 Postsurgical leaks: n = 29 Single stent: 72% (21/29) Multiple stents: 28% (8/29) Excluded from analysis because patients were included with active malignancy: 1 Perforations: n = 10 2 Fistulae: n = 15	PC SEMS: 100% (19/19) - 4 to 6 wk FC SEMS: 100% (30/30) - 6 to 8 wk SEPS: 100% (15/15) - 6 to 8 wk	Not analyzed for subgroup of patients with anastomotic leaks ≥ 3 mo FU: 100%	No subgroup analysis for patients with esophageal leaks 1 Chest pain 2 GI Bleed 3 Pneumothorax 4 Increase size of leak during deployment 5 Breakage of stent 6 Dysphagia 7 Aspiration pneumonia Stent migration not analyzed for subgroup of patients with esophageal leaks Mortality rate: 0% (0/29)	No subgroup analysis for patients with postsurgical leaks -Stent-in-stent procedure: 2 -Breakage of stent: 1	Overall: 82.8% (24/29) -Primary closure rate: 72% (21/29) -Secondary closure rate: 38% (3/8)
Freeman et al[31] 2014	Retrospect	Patients with intrathoracic leak after surgical repair of an acute iatrogenic esophageal perforation: n = 29 Single stent: 100% (29/29)	SEPS: 100% (24/24) FC SEMS: 100% (5/5) Mean time to removal: 22 (13-41) d	PEG: 10.3% (3/29) Thoracoscopic decortication: 10.3% (3/29) Jejunostomy: 3.4% (1/29) Median FU: 6 wk	No stent-related complications. Stent migration: 17.2% (5/29) - not analyzed according to stent type Mortality rate: 0% (0/29)	100% (25/25) Not analyzed according to stent type	86.2% (25/29)
Gubler et al[32] 2014	Retrospect	Patients with benign (gastro)esophageal leaks, fistulae or perforations: n = 85 1 Iatrogenic perforations: n = 32 2 Anastomotic leaks: n = 31 3 Fistulae: n = 7 4 Boerhaave: n = 7 5 Other perforations: n = 8 Single stent: 78% (66/85) Multiple stents: 22% (19/85)	Total SEMS: n = 113 PC SEMS: n = 72 FC SEMS: n = 28 Unknown: n = 13 Technical success: 100% Average time to removal: 15 (1-111) d	Percutaneous/thoracoscopic drainage: 55.3% (47/85) OTSC: 2.4% (2/85) Vacuum-therapy: 2.4% (2/85) FU: at least 4 wk after stent removal	Stent migration: 8.8% (10/113) - not analyzed according to stent type Food bolus obstruction: 0.9% (1/113) - not analyzed according to stent type Mortality rate: 9.4% (8/85) 1 Unrelated to in situ stent: 3.5% (3/85) 2 Multi-organ failure: 2.4% (2/85) 3 Acute respiratory distress syndrome: 1.2% (1/85) 4 Heart insufficiency: 1.2% (1/85) 5 Aortic dissection: 1.2% (1/85)	98.2% (107/109) - Irremovable: 2 - Spontaneous passage after migration: 1 Not analyzed according to stent type	Overall: 79% (67/85) -Postsurgical leaks: 74% (23/31) -Fistulae: 43% (3/7) -Iatrogenic: 94% (30/32) -Boerhaave: 71% (5/7) -Others: 75% (6/8) PC SEMS: 68% (49/72) FC SEMS: 54% (15/28)
Orive-Calzada et al[33] 2014	Pro- and retrospect	Patients treated with FC SEMS for benign upper gastrointestinal fistulae and perforations: n = 56 1 Postsurgical leaks: n = 44 2 Iatrogenic perforations: n = 6 3 Boerhaave syndrome: n = 4 4 Other perforations: n = 2 Single stent: 59% (33/56) Multiple stents: 41% (23/56)	FC SEMS: 100% (87/87) PC SEMS: 100% (1/1) Median time to removal: 42 (9-1460) d	Surgical drainage: 30% (17/56) Percutaneous drainage: 41% (23/56) FU: unknown	Minor complications: Atrial fibrillation: 1.8% (1/56) Major complications: Stent-related perforation: 5.4% (3/56) Stent migration: 20.5% (18/88) - FC SEMS: 20.7 (18/87) - PC SEMS: 0% (0/1) Mortality rate: 16% (9/56) - cerebrovascular accident: 1.8% (1/56) - nosocomial pneumonia: 1.8% (1/56) - neoplasia: 1.8% (1/56) - secondary to sepsis: 10.7% (6/56)	FC SEMS: 100% (87/87) PC SEMS: 0/1 -Stent-in-stent procedure: 1	Overall: 79% (44/56) -Postsurgical leaks: 78% (36/46) -Perforations: 80% (8/10)
Persson et al[34] 2014	Retrospect	Patients with benign spontaneous, iatrogenic or traumatic esophageal perforations: n = 40 1 Iatrogenic perforation: n = 16 2 Boerhaave syndrome: n = 23 3 Other perforations: n = 1 Single stent: missing Multiple stents: missing	Total No. of stents missing Stent type missing Time to removal: 4-6 wk	Unknown FU: unknown	No stent-related complications Stent migration not analyzed according to stent type Mortality rate: 7.5% (3/40) 1 Multi-organ failure: 5% (2/40) 2 Respiratory insufficiency without sepsis: 2.5% (1/40)	Stent type and no. of stents removed missing -Removal during second procedure: 1	82.5% (33/40) No subgroup analysis according to etiology
Sharaiha et al[35] 2014	Retrospect	Patients treated with stent placement for benign upper GI leaks: n = 18 1 Postsurgical leaks: n = 12 2 Iatrogenic perforation: n = 1 3Other fistulae: n = 5 Single stent: 28% (5/18) Multiple stents: 72% (13/18)	Total stents: n = 47 1 FC SEMS 2 PC SEMS 3 SEPS 4 Uncovered Technical success: 100% Mean time to removal: 54 (18-118) d	Clip/endoloop: 27.8% (5/18) Dilation: 33.3% (6/18) Surgery: 16.7% (3/18) FU: median 283 d (IQR 38-762)	Overall 9 complications in 5 patients 5 minor complications in 4 patients: - reflux/esophagitis: 16.7% (3/18) - abdominal pain: 5.6% (1/18) - collapsed stent: 5.6% (1/18) 4 Major complications in 3 patients: - aspiration pneumonia: 11.1% (2/18) - perforation: 5.6% (1/18) - stricture: 5.6% (1/18) Tissue hyperplasia: 5.6% (1/47) - stent type unknown Food impaction/bezoar: 11.1% (2/47) - stent type unknown Stent migration not analyzed for subgroup of patients with esophageal leaks Overall mortality rate: 5.6% (1/18) Not specified	No subgroup analysis for patients with benign leaks -Stent-in-stent procedure: 7 -Irremovable uncovered stent: 1	Overall: 47% (7/15) -Postsurgical leaks: (5/11) -Fistula: 67% (2/3) -Iatrogenic: 0% (0/1)
Shim et al[36] 2014	Retrospect	Patients who underwent endoscopic treatment for anastomotic leakage after total gastrectomy: n = 27 1 FC SEMS: n = 13 2 Non stent therapy: n = 14 Single stent: 85% (11/13) Multiple stents: 15% (2/13)	FC SEMS: 100% (15/15) PC SEMS: 100% (1/1) Median time to removal: 38 (0-69) d	Concurrent fluid drainage: 61.5% (8/13) FU: unknown	Minor complication: Stent malposition: 6.3% (1/13) Stent migration: 25% (4/16) - FC SEMS: 26.7% (4/15) - PC SEMS: 0% (0/1) Tissue in- or overgrowth: 6.3% (1/16) - FC SEMS: 6.7% (1/15) Mortality rate: 15.4% (2/13) - sepsis related: 7.7% (1/13) - non-stent related bleeding: 7.7% (1/13)	FC SEMS: 100% (11/11) PC SEMS: 100% (1/1)	Overall: 67% (8/12) -Primary closure rate: 67% (8/12) -Secondary closure rate: 0% (0/4)
Brangewitz et al[37] 2013	Retrospect	Patients with esophageal defects treated with stent placement: n = 39 1 Postsurgical leaks: n = 31 2 Iatrogenic perforations: n = 6 3 Boerhaave syndrome: n = 2 Single stent: 100% (39/39)	FC SEMS: 100% (39/39) Median time to removal: 33 (9-132) d	Unknown FU: unknown	Minor complications: - stent-related ulcers: 12.8% (5/39) Major complications: - severe bleed at upper end of stent: 2.6% (1/39) - death due to esophageal necrosis at proximal end of stent: 2.6% (1/39) Stent migration: 15.4% (6/39) Mortality rate: 25.6% (10/39) - esophageal necrosis at proximal stent end: 2.6% (1/39) - not specified: 23.1% (9/39)	FC SEMS: 90.3% (28/31) -Self-limiting bleed: 2 -Migrated stent requiring surgical removal: 1	53.8% (21/39) No subgroup analysis according to etiology
Leenders et al[38] 2013	Retrospect	Patients with anastomotic leakage after esophageal resection or bariatric surgery: n = 26 Single stent: 81% (21/26) Multiple stents: 19% (5/26)	FC SEMS: 100% (31/31) PC SEMS: 100% (2/2) Mean time to removal: 11 (1-63) wk	Unknown FU: range 2-144 wk	Minor complications: - stent disintegration all with FC SEMS: 11.5% (3/26) Major complications: - stent-related perforation with FC SEMS: 3.8% (1/26) Stent migration: 24.2% (8/33) - FC SEMS: 25.8% (8/31) Tissue ingrowth: 6.1% (2/33) - PC SEMS: 100% (2/2) Mortality rate: 19.2% (5/26) - sepsis-related: 19.2% (5/26)	FC SEMS: 100% (26/26) PC SEMS: 0% (0/2) -Traumatic removal due to tissue ingrowth: 2	80.8% (21/26)
Wilson et al[39] 2013	Retrospect	Patients treated with FC SEMS placement for benign esophagogastric diseases: n = 33 1 Perforation: n = 7 2 Anastomotic leak: n = 14 3 Sleeve gastrectomy leak: n = 6 4 Fistula: n = 6 Single stent: missing Multiple stents: missing	FC SEMS: 100% (40/40) Average time to removal: 47 d	Drainage procedure: 66.7% (22/33) VATS/open: 36.4% (12/33) Tube thoracostomy: 21.2% (7/33) Percutaneous: 9.1% (3/33) FU: unknown	Major complications: - severe hemorrhage from aorta-esophageal fistula: 3.0% (1/33) No subgroup analysis for patients with esophageal leaks, fistulae and perforations: - stent migration - food impaction Mortality rate: 0% (0/33)	No subgroup analysis for patients with esophageal leaks, fistulae and perforations -Stent fracture: 2	94% (31/33) avoided open repair -Postsurgical leaks: 95% (19/20) -Perforations: 86% (6/7) -Fistulae: 100% (6/6)
Van Boeckel et al[40] 2012	Retrospect	Patients treated with a SEMS or SEPS for sealing a benign esophageal rupture or anastomotic leak: n = 52 1 Anastomotic leak: n = 32 2 Iatrogenic perforation: n = 13 3 Boerhaave syndrome: n = 4 4 Others: n = 3 Single stent: missing Multiple stents: missing	PC SEMS: 98% (60/61) FC SEMS: 100% (15/15) SEPS: 100% (7/7) Median time to removal: 25 (1-197) d	Concurrent fluid drainage: 46.2% (24/52) Median FU: 470 (25-1200) d	Major complications: Severe retrosternal pain: 3.8% (2/52) - all PC SEMS Hemorrhage: 3.8% (2/52) - FC SEMS: stent-related death 1.9% (1/52) - PC SEMS: required adrenaline injections: 1.9% (1/52) Ruptured stent cover: 7.2% (6/83) - PC SEMS: 9.8% (6/61) Tissue in-/overgrowth: 9.6% (8/83) - PC SEMS: 13.1% (8/61) Stent migration: 12.0% (10/83) - FC SEMS: 20% (3/15) - PC SEMS: 10% (6/61)	88.7% (63/71) Tissue in- and/or overgrowth at removal of 8 PC SEMS -Stent-in-stent procedure: 4 -Esophageal rupture: 2 -Second endoscopic procedure: 1 -Esophagectomy: 1 Not analyzed according to stent type	65.4% (34/52) No subgroup analysis according to etiology PC SEMS: 69% FC SEMS: 56% SEPS: 71%
					- SEPS: 14% (1/7) Food obstruction: 3.6% (3/83) - PC SEMS: 4.9% (3/61) Mortality rate: 13.5% (7/52) - severe stent-related hemorrhage: 1.9% (1/52) - sepsis related: 7.7% (4/52) - malignancy: 1.9% (1/52) - active euthanasia: 1.9% (1/52)
Buscaglia et al[41] 2011	Retrospect	Patients treated for benign esophageal conditions by FC SEMS placement: - fistula or leak: n = 15 Single stent: 67% (10/15) Multiple stents: 33% (5/15)	FC SEMS: 100% (24/24) Median time to removal: 42.5 (3-122) d	Unknown FU: unknown	Stent migration: 33.3% (8/24) Further complications not analyzed for subgroup of patients with fistulae and leaks - chest pain - globus sensation Mortality rate: 6.7% (1/15) - paraspinal abscess related to persistent fistula	No subgroup analysis for patients with esophageal leaks and fistulae -Removal during surgery: 1 -Stent-in-stent procedure: 1	79% (11/14) No subgroup analysis according to etiology
Dai et al[42] 2011	Retrospect	Patients treated with SEPS for: - postoperative esophageal anastomotic leaks: n = 30 Single stent: missing Multiple stents: missing Excluded from analysis because patients were included with active malignancy: - esophageal perforations: n = 6 - fistulae: n = 5	Total no. of SEPS missing Technical success: 100% Mean time to stent removal: 30 (7-62) d	Interventional drainage: 40% (12/30) Tracheotomy: 43% (13/30) Mean FU: 12.8 (1-61) mo	Major complications: - stent dislocation and inability to place new stent requiring rethoracotomy: 3.3% (1/30) Stent migration not analyzed for subgroup of patients with esophageal leaks Mortality rate: (2/30) - persistent sepsis and multi-organ failure: 6.7% (2/30)	No. of removed stents missing One migrated stent in a patient with an esophago-colonic anastomotic leak could not be removed	90% (27/30)
David et al[43] 2011	Pro- and retrospect	Patients treated with SEMS for esophageal or gastric perforation and intrathoracic contamination: n = 30 - postsurgical leak: n = 13 - boerhaave syndrome: n = 6 - iatrogenic perforation: n = 6 - fistulae: n = 4 - other perforation: n = 1 Single stent: 50% (15/30) Multiple stents: 50% (15/30)	At least 62 stents - FC SEMS - PC SEMS Technical success: 100% Average duration of stenting: 29 d	Chest tube thoracostomy: - Alone: 23.3% (7/30) - Additional intervention: 76.7% (23/30) Pleural decortication: 56.7% (17/30) Muscle-flap reinforcement: 36.7% (11/30) Average FU: 8.1 mo	Minor complications: - pain: 6.7% (2/30) - hiccups: 3.3% (1/30) - nausea: 3.3% (1/30) Major complications: - bowel obstruction: 6.7% (2/30) - erosion: 3.3% (1/30) - left atrial compression: 3.3% (1/30) Stent migration: 6.7% (2/30) - not analyzed according to stent type Mortality rate: 10% (3/30) - multi-organ failure: 3.3% (1/30) - multiple emboli caused by esophago-atrial fistula: 3.3% (1/30) - aspiration during contrast study: 3.3% (1/30)	No. of removed stents missing Not analyzed according to stent type	76.7% (23/30) No subgroup analysis according to etiology
Eloubeidi et al[13] 2011	Pro- and retrospect	Patients with benign esophageal lesions treated with Alimaxx-E stent: n = 16 - postsurgical leaks: n = 11 - fistula: n = 1 - iatrogenic perforations: n = 3 - other: n = 1 Single stent: 81% (13/16) Multiple stents: 19% (3/16)	FC SEMS: 100% (16/16) In situ for: 51 ± 45 d (range 9-163)	Dilation: 6.3% (1/16) PEG placement: 6.3% (1/16) FU: unknown	Minor complications: 1 Stent infolding/invagination: 6.3% (1/16) 2 Chest pain: 6.3% (1/16) 3 Dysphagia: 6.3% (1/16) 4 Globus sensation: 6.3% (1/16) Major complications: 1 Respiratory compromise: 6.3% (1/16) 2 Aspiration pneumonia: 12.5% (2/16) Stent migration: 31.3% (5/16) Mortality rate: 0% (0/16)	FC SEMS: 100% (16/16) One stent was retrieved in two pieces	43.8% (7/16) No subgroup analysis according to etiology
Freeman et al[44] 2011	Unknown	Hospitalized patients with an anastomotic leak after esophagectomy: n = 17 Single stent: 100% (17/17)	SEPS: 100% (14/14) FC SEMS: 100% (3/3) Mean time to removal: 17 (12-27) d	VATS pleural drainage: 29.4% (5/17) Pharyngostomy: 5.9% (1/17) Tube jenunostomy: 5.9% (1/17) FU: at least 3 mo after stent removal	No complications associated with stent placement or removal Stent migration: 17.6% (3/17) - not analyzed according to stent type Mortality rate: 0% (0/17)	SEPS: 100% (14/14) FC SEMS: 100% (3/3)	94% (16/17)
Nguyen et al[45] 2011	Retrospect	Patients who developed postoperative leaks after minimally invasive esophagectomy: n = 18 - conventional treatment: n = 9 - FC SEMS placement: n = 9 Single stent: 100% (9/9)	FC SEMS: 100% (9/9) Removal after 6 wk	Percutaneous drainage: 22% (2/9) Tracheostomy: 11% (1/9) FU: unknown	No stent-related complications Mortality rate: 0% (0/9)	FC SEMS: 100% (9/9)	100% (9/9)
Schweigert et al[46] 2011	Retrospect	Patients treated with stent placement for intrathoracic leak after esophagectomy: n = 12 Single stent: 100% (12/12)	PC SEMS: 100% (12/12) Median time to removal: 48 (16-99) d	Tube thoracostomy: 100% (12/12) FU: unknown	Major complications: 1 Death by hemorrhage from stent-related erosion into the aorta: 8.3% (1/12) 2 Stent-related fistula after removal: 8.3% (1/12) Stent migration: n = missing Mucosal hyperproliferation: n = missing Mortality rate: 16.7% (2/12) 1 Stent-related death by hemorrhage: 8.3% (1/12) 2 Pulmonary aspiration after stent removal and successful healing of the leak: 8.3% (1/12)	PC SEMS: 100% (10/10)	81.8% (9/11)
Swinnen et al[47] 2011	Retrospect	Patient treated with PC SEMS placement for benign upper GI leaks or perforations: n = 88 - postsurgical leaks: n = 65 - boerhaave syndrome: n = 4 - iatrogenic perforation: n = 14 - other perforations: n = 5	PC SEMS: 100% (153/153) Median time to removal for 33 PC SEMS: 23 d Median time to removal for 99 PC SEMS: 69 d	Drainage of collections: 47.7% (42/88) - Surgical: 26.1% (23/88) - Percutaneous: 15.9% (14/88) - Endoscopic: 5.7% (5/88)	Minor complications: - transient stent-related dysphagia: 11.4% (10/88) Major complications: - bleeding requiring intervention: 5.7% (5/88) - stent-related perforation: 1.1% (1/88)	PC SEMS: 24.4% (33/135) Stent-in-stent procedure: 73.3% (99/135) Removal during surgery: 2.2% (3/135)	77.6% (59/76) No subgroup analysis according to etiology
		Single stent: 58% (51/88) Multiple stents: 42% (37/88)		Follow-up after removal: 3 mo: 83% 7 mo: 81% 1 yr: 72%	- tracheal compression: 1.1% (1/88) - dysphagia due to tissue hyperplasia: 18.2% (16/88); PC SEMS: 10.5% (16/153) Stent migration: 11.1% (17/153) of PC SEMS mortality rate: 10.2% (9/88) 1 Sepsis related: 3.4% (3/88) 2 Pulmonary embolism: 1.1% (1/88) 3 Full-blown AIDS: 1.1% (1/88) 4 Cardiac disease: 1.1% (1/88) Three additional deaths during first 3 mo after treatment: 1 Sepsis after surgery: 1.1% (1/88) 2 Tension pneumothorax: 1.1% (1/88) 3 Pneumonia: 1.1% (1/88)

FC SEMS: Fully covered self-expandable metal stent; FU: Follow-up; PC SEMS: Partially covered self-expandable metal stent; SEPS: Self-expandable plastic stent; VATS: Video-assisted thoracic surgery; PEG: Percutaneous endoscopic gastrostomy; OTSC: Over-the-scope-clips; IQR: Interquartile range.