Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia

R. Kozarek, S. Raltz, N. Marcon, P. Kortan, C. Lightdale, P. Stevens, Glen Lehman, Douglas Rex, S. Benjamin, D. Fleischer, I. Waxman

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)298
Number of pages1
JournalGastrointestinal Endoscopy
Volume43
Issue number4
StatePublished - 1996
Externally publishedYes

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Deglutition Disorders
Multicenter Studies
Stents
Fistula
Dilatation
Pathologic Constriction
Exsanguination
Aspiration Pneumonia
Neoplasms
Silicones
Prostheses and Implants
Stomach
Referral and Consultation
Demography
Survival
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Kozarek, R., Raltz, S., Marcon, N., Kortan, P., Lightdale, C., Stevens, P., ... Waxman, I. (1996). Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia. Gastrointestinal Endoscopy, 43(4), 298.

Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia. / Kozarek, R.; Raltz, S.; Marcon, N.; Kortan, P.; Lightdale, C.; Stevens, P.; Lehman, Glen; Rex, Douglas; Benjamin, S.; Fleischer, D.; Waxman, I.

In: Gastrointestinal Endoscopy, Vol. 43, No. 4, 1996, p. 298.

Research output: Contribution to journalArticle

Kozarek, R, Raltz, S, Marcon, N, Kortan, P, Lightdale, C, Stevens, P, Lehman, G, Rex, D, Benjamin, S, Fleischer, D & Waxman, I 1996, 'Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia', Gastrointestinal Endoscopy, vol. 43, no. 4, pp. 298.
Kozarek R, Raltz S, Marcon N, Kortan P, Lightdale C, Stevens P et al. Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia. Gastrointestinal Endoscopy. 1996;43(4):298.
Kozarek, R. ; Raltz, S. ; Marcon, N. ; Kortan, P. ; Lightdale, C. ; Stevens, P. ; Lehman, Glen ; Rex, Douglas ; Benjamin, S. ; Fleischer, D. ; Waxman, I. / Prospective multicenter trial of 25 mm flanged esophageal z® stents for malignant dysphagia. In: Gastrointestinal Endoscopy. 1996 ; Vol. 43, No. 4. pp. 298.
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abstract = "Previous work has suggested that currently marketed Z{\circledR} 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{\circledR} stent modified with 25 mm flanges. Materials and Methods: All pts who had placement of modified Z{\circledR} 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{\circledR} 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{\circledR} stents to migrate at time of placement or follow-up has largely been overcome with 25 mm funnels.",
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AU - Raltz, S.

AU - Marcon, N.

AU - Kortan, P.

AU - Lightdale, C.

AU - Stevens, P.

AU - Lehman, Glen

AU - Rex, Douglas

AU - Benjamin, S.

AU - Fleischer, D.

AU - Waxman, I.

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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.

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