Covered nitinol stents for the treatment of esophageal strictures and leaks

Table 1 Indication for use of the stent in 65 patients

	n (%)
Esophageal carcinoma	51 (78.5)
Adenocarcinoma	31
Squamous-cell carcinoma	20
Complications of esophagogastric anastomosis	8 (12.3)
Fistula	3
Stricture	3
Tumor recurrence	2
Extrinsic compression	4 (6.1)
Lung cancer	2
Pleural mesothelioma	1
Mediastinal lymphoma	1
Post-radiotherapy stricture	2 (3.1)

Table 2 Classification of dysphagia

Grade	Definition
0	Normal swallowing
1	Able to swallow some solid food
2	Able to swallow semi-liquid food
3	Able to swallow liquids only
4	Absolute dysphagia

Table 3 Demographic and clinical data of the patient population

	Total	Ultraflex	Choostent	P-value
Patients	65	33	32	-
Male/female	43/22	23/10	20/12	0.5
Mean age (range)	67.5 (34-86)	66.8 (34-83)	68.3 (42-86)	0.6
Grade of dysphagia (mean ± SD)	3.4 ± 0.4	3.4 ± 0.3	3.5 ± 0.4	0.9
Diagnosis
Adenocarcinoma	31	16	15	0.9
Squamous cell carcinoma	20	11	9	0.8
Extrinsic compression	4	2	2	0.9
Anastomotic fistula	3	2	1	0.6
Anastomotic stricture	3	1	2	0.5
Anastomotic recurrence	2	1	1	0.9
Post-radiotherapy stricture	2	0	2	0.1
Site of lesion
Cervical	3	2	1	0.6
Upper thoracic	9	6	3	0.3
Middle thoracic	21	11	10	0.9
Lower thoracic	32	14	18	0.4
Tumor stage (n = 51)
III	19	12	7	0.6
IVA	17	8	9	0.7
IVB	15	7	8	0.5

Table 4 In-hospital characteristics and long-term outcome after stent placement

	Ultraflex (n = 33)	Choostent (n = 32)	P-value
Duration of the procedure (min)	16 (12-35)	17 (13-27)	0.8
Median hospital stay (d)	2 (2-7)	2 (2-4)	0.7
Hospital mortality (%)	0	0	1.0
Hospital morbidity (%)	6.1 (2/33)	6.2 (2/32)	0.8
Pain score (scale 0-10)	6.3	4.8	0.2
Residual dysphagia (grade)	1.9 ± 0.3	2.1 ± 0.4	0.6
Mean survival (mo)	6.5 (1-19)	6 (3-26)	0.7

Table 5 Early and late complications after stent placement

	n (%)	Ultraflex (n = 33)	Choostent (n = 32)	P-value
Abrasion of soft palate	1 (1.5)	1	0	0.3
Odynophagia	1 (1.5)	0	1	0.3
Malposition	1 (1.5)	0	1	0.3
Late distal migration	3 (4.6)	2	1	0.6
Persistent chest pain	3 (4.6)	2	1	0.6
Persistent hiccups	3 (4.6)	1	2	0.6
Gastroesophageal reflux	14 (22)	7	7	0.9
Food obstruction	5 (7.6)	2	3	0.6