TY - JOUR
T1 - Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia
AU - Kozarek, R.
AU - Raltz, S.
AU - Marcon, N.
AU - Kortan, P.
AU - Lightdale, C.
AU - Stevens, P.
AU - Lehman, G.
AU - Rex, D.
AU - Benjamin, S.
AU - Fleischer, D.
AU - Waxman, I.
PY - 1996
Y1 - 1996
N2 - Previous work has suggested that currently marketed Z® steals (18 mm internal diameter, 22 mm flanges) have a tendency to migrate particularly when placed across the EG junction. Accordingly, we prospectively studied all patients (pts) who underwent placement of a silicone covered Z® stent modified with 25 mm flanges. Materials and Methods: All pts who had placement of modified Z® stents at 6 university and regional referral hospitals between 2/95-11/95 were assessed. Data included pt demographics, indication for prosthesis placement, previous therapy, malignancy location, presence of TE fistula, stricture length, and % wall involvement. Procedural data included degree of esophageal dilation, procedural problems, and subsequent complications. Pre- and post-procedure dysphagia (0-4), ability to completely occlude a TE fistula, and survival times were also defined. Results: 25 pts with malignant dysphagia (13M, 12F, x age 71 yrs) underwent placement of 27 Z stems for malignant dysphagia. Previous therapy included chemo Rx ± irradiation 19, surgery 5, dilation 19, tube feed 4, other stent Rx 6, and misc. Rx 2. Tumor location was proximal 1, mid-distal 14, and distal-EG junction 12. 7 pts had TE fistulas. Mean luminal diameter was 7.7 mm and mean stricture length was 6 cm (2.2 cm SD). Technically pts were dilated to a median of 42 Fr (2.5 Fr SD). Placement problems included inadvertent proximal (1) or distal (1) deployment, and 1 pt each had migration into the stomach at time of placement and stent dislodgement with guidewire retrieval (4/27, 15%). Major complications included perforation with insertion 1 (spontaneously sealed), exsanguination 2 (days 32, 199), aspiration pneumonia 2, migration post-placement 1 (38 d) and tumor overgrowth 1 (45 d). x pre/post-stent dysphagia scores were 2.7 (0.9 SD) and 1.4 (1.35 SD) and 4/7 TE fistulas were completely sealed. 14 pts have died at a x 57 (5/d SD) days and 9 remain alive at a x 50 (36d SD) days. Conclusions: 1) Esophageal Z® stents can be placed in the majority of pts with malignant dysphagia with an acceptable rate of placement problems and subsequent stent-related complications; 2) the tendency for 22 mm flanged Z® stents to migrate at time of placement or follow-up has largely been overcome with 25 mm funnels.
AB - Previous work has suggested that currently marketed Z® steals (18 mm internal diameter, 22 mm flanges) have a tendency to migrate particularly when placed across the EG junction. Accordingly, we prospectively studied all patients (pts) who underwent placement of a silicone covered Z® stent modified with 25 mm flanges. Materials and Methods: All pts who had placement of modified Z® stents at 6 university and regional referral hospitals between 2/95-11/95 were assessed. Data included pt demographics, indication for prosthesis placement, previous therapy, malignancy location, presence of TE fistula, stricture length, and % wall involvement. Procedural data included degree of esophageal dilation, procedural problems, and subsequent complications. Pre- and post-procedure dysphagia (0-4), ability to completely occlude a TE fistula, and survival times were also defined. Results: 25 pts with malignant dysphagia (13M, 12F, x age 71 yrs) underwent placement of 27 Z stems for malignant dysphagia. Previous therapy included chemo Rx ± irradiation 19, surgery 5, dilation 19, tube feed 4, other stent Rx 6, and misc. Rx 2. Tumor location was proximal 1, mid-distal 14, and distal-EG junction 12. 7 pts had TE fistulas. Mean luminal diameter was 7.7 mm and mean stricture length was 6 cm (2.2 cm SD). Technically pts were dilated to a median of 42 Fr (2.5 Fr SD). Placement problems included inadvertent proximal (1) or distal (1) deployment, and 1 pt each had migration into the stomach at time of placement and stent dislodgement with guidewire retrieval (4/27, 15%). Major complications included perforation with insertion 1 (spontaneously sealed), exsanguination 2 (days 32, 199), aspiration pneumonia 2, migration post-placement 1 (38 d) and tumor overgrowth 1 (45 d). x pre/post-stent dysphagia scores were 2.7 (0.9 SD) and 1.4 (1.35 SD) and 4/7 TE fistulas were completely sealed. 14 pts have died at a x 57 (5/d SD) days and 9 remain alive at a x 50 (36d SD) days. Conclusions: 1) Esophageal Z® stents can be placed in the majority of pts with malignant dysphagia with an acceptable rate of placement problems and subsequent stent-related complications; 2) the tendency for 22 mm flanged Z® stents to migrate at time of placement or follow-up has largely been overcome with 25 mm funnels.
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U2 - 10.1016/S0016-5107(96)80032-0
DO - 10.1016/S0016-5107(96)80032-0
M3 - Article
AN - SCOPUS:10544235892
SN - 0016-5107
VL - 43
SP - 298
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 4
ER -