WALLSTENT® esophageal prosthesis: Post-market surveillance study

J. Lavergne, K. Fields, J. S. Barkin, D. L. Carr-Locke, R. A. Kozarek, S. E. Silvis, D. E. Fleischer

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Palliation of esophageal carcinoma has included esophageal prosthesis insertion. Recently, a self-expanding, silicone-covered, WALLSTENT has been introduced. The purpose of this nation-wide, post-market surveillance study was to evaluate the safety, efficacy and morbidity associated with this new stent. METHODS: Survey forms were sent to 56 gastroenterologists who had placed WALLSTENTS. The completed forms were tabulated by MedProbe™, Inc. Demographic data, symptomatology and treatments preand post stent placement as well as morbidity and mortality at 0, 30, and 60 days were analyzed. Dysphagia scores were: 0 - no dysphagia; 1 - solids; 2 - semi-solids; 3 - liquids and 4 -unable to swallow. RESULTS: 101 (27%) forms were returned; the patients' mean age at diagnosis was 68.5 years and male:female ratio was 3.6/1.00. The average time after diagnosis to stent placement was 220 days ± 408 SD; average time of follow-up after diagnosis was 280 days ± 404 SD. Average length of stricture was 5.9 ± 3.6 cm with the majority of the strictures (89%) located at/or distal to the mid-esophagus. 31/101 patients (31%) were alive at 60 days post stent placement. The mean pre-stent dysphagia score was 3, 1.5 at 48 h. and 1.2 at 30 days post-stent. There was a significant improvement (p<0.01) at 48 h. and 30 days after stent placement. The complication rate at the time of stent placement was 12%; 24/100 (24%) at 48 h. and 32/95 (34%) after 48 h. Immediate complications included: failure to deploy - 3; difficulty removing the stent catheter system - 3; perforation - 2; aspiration - 1; inadequate placement -1; and unspecified - 2. Complications at 48 h, included moderate/severe pain 15 (15%); aspiration 3 (3%), nausea & vomiting 3 (3%); GI bleed 2 (2%) and stent migration 2 (2%). Complications beyond the 48-hour period were: moderate/severe pain 14 (14%); GI bleed 9 (9%); tumor overgrowths (5%); aspiration 2 (2%) and stent migration 1 (1%). CONCLUSION: 1) Self-expanding, silicone-covered WALLSTENT results in significant improvement in dysphagia; 2) immediate placement complications occur in 12% of patients; 3) pain is the most frequent complication (15%) at 48 h. and beyond; 4) stent migration occurs in 3% of patients and tumor overgrowth occurs in 5%. SUMMARY: WALLSTENTS offer excellent palliation of dysphagia with acceptable morbidity and mortality rate.

Original languageEnglish (US)
Pages (from-to)339
Number of pages1
JournalGastrointestinal Endoscopy
Volume43
Issue number4
StatePublished - 1996
Externally publishedYes

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Prostheses and Implants
Stents
Deglutition Disorders
Silicones
Morbidity
Pain
Pathologic Constriction
Mortality
Deglutition
Nausea
Esophagus
Vomiting
Neoplasms
Catheters
Demography
Carcinoma
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Lavergne, J., Fields, K., Barkin, J. S., Carr-Locke, D. L., Kozarek, R. A., Silvis, S. E., & Fleischer, D. E. (1996). WALLSTENT® esophageal prosthesis: Post-market surveillance study. Gastrointestinal Endoscopy, 43(4), 339.

WALLSTENT® esophageal prosthesis : Post-market surveillance study. / Lavergne, J.; Fields, K.; Barkin, J. S.; Carr-Locke, D. L.; Kozarek, R. A.; Silvis, S. E.; Fleischer, D. E.

In: Gastrointestinal Endoscopy, Vol. 43, No. 4, 1996, p. 339.

Research output: Contribution to journalArticle

Lavergne, J, Fields, K, Barkin, JS, Carr-Locke, DL, Kozarek, RA, Silvis, SE & Fleischer, DE 1996, 'WALLSTENT® esophageal prosthesis: Post-market surveillance study', Gastrointestinal Endoscopy, vol. 43, no. 4, pp. 339.
Lavergne J, Fields K, Barkin JS, Carr-Locke DL, Kozarek RA, Silvis SE et al. WALLSTENT® esophageal prosthesis: Post-market surveillance study. Gastrointestinal Endoscopy. 1996;43(4):339.
Lavergne, J. ; Fields, K. ; Barkin, J. S. ; Carr-Locke, D. L. ; Kozarek, R. A. ; Silvis, S. E. ; Fleischer, D. E. / WALLSTENT® esophageal prosthesis : Post-market surveillance study. In: Gastrointestinal Endoscopy. 1996 ; Vol. 43, No. 4. pp. 339.
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abstract = "Palliation of esophageal carcinoma has included esophageal prosthesis insertion. Recently, a self-expanding, silicone-covered, WALLSTENT has been introduced. The purpose of this nation-wide, post-market surveillance study was to evaluate the safety, efficacy and morbidity associated with this new stent. METHODS: Survey forms were sent to 56 gastroenterologists who had placed WALLSTENTS. The completed forms were tabulated by MedProbe™, Inc. Demographic data, symptomatology and treatments preand post stent placement as well as morbidity and mortality at 0, 30, and 60 days were analyzed. Dysphagia scores were: 0 - no dysphagia; 1 - solids; 2 - semi-solids; 3 - liquids and 4 -unable to swallow. RESULTS: 101 (27{\%}) forms were returned; the patients' mean age at diagnosis was 68.5 years and male:female ratio was 3.6/1.00. The average time after diagnosis to stent placement was 220 days ± 408 SD; average time of follow-up after diagnosis was 280 days ± 404 SD. Average length of stricture was 5.9 ± 3.6 cm with the majority of the strictures (89{\%}) located at/or distal to the mid-esophagus. 31/101 patients (31{\%}) were alive at 60 days post stent placement. The mean pre-stent dysphagia score was 3, 1.5 at 48 h. and 1.2 at 30 days post-stent. There was a significant improvement (p<0.01) at 48 h. and 30 days after stent placement. The complication rate at the time of stent placement was 12{\%}; 24/100 (24{\%}) at 48 h. and 32/95 (34{\%}) after 48 h. Immediate complications included: failure to deploy - 3; difficulty removing the stent catheter system - 3; perforation - 2; aspiration - 1; inadequate placement -1; and unspecified - 2. Complications at 48 h, included moderate/severe pain 15 (15{\%}); aspiration 3 (3{\%}), nausea & vomiting 3 (3{\%}); GI bleed 2 (2{\%}) and stent migration 2 (2{\%}). Complications beyond the 48-hour period were: moderate/severe pain 14 (14{\%}); GI bleed 9 (9{\%}); tumor overgrowths (5{\%}); aspiration 2 (2{\%}) and stent migration 1 (1{\%}). CONCLUSION: 1) Self-expanding, silicone-covered WALLSTENT results in significant improvement in dysphagia; 2) immediate placement complications occur in 12{\%} of patients; 3) pain is the most frequent complication (15{\%}) at 48 h. and beyond; 4) stent migration occurs in 3{\%} of patients and tumor overgrowth occurs in 5{\%}. SUMMARY: WALLSTENTS offer excellent palliation of dysphagia with acceptable morbidity and mortality rate.",
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T1 - WALLSTENT® esophageal prosthesis

T2 - Post-market surveillance study

AU - Lavergne, J.

AU - Fields, K.

AU - Barkin, J. S.

AU - Carr-Locke, D. L.

AU - Kozarek, R. A.

AU - Silvis, S. E.

AU - Fleischer, D. E.

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N2 - Palliation of esophageal carcinoma has included esophageal prosthesis insertion. Recently, a self-expanding, silicone-covered, WALLSTENT has been introduced. The purpose of this nation-wide, post-market surveillance study was to evaluate the safety, efficacy and morbidity associated with this new stent. METHODS: Survey forms were sent to 56 gastroenterologists who had placed WALLSTENTS. The completed forms were tabulated by MedProbe™, Inc. Demographic data, symptomatology and treatments preand post stent placement as well as morbidity and mortality at 0, 30, and 60 days were analyzed. Dysphagia scores were: 0 - no dysphagia; 1 - solids; 2 - semi-solids; 3 - liquids and 4 -unable to swallow. RESULTS: 101 (27%) forms were returned; the patients' mean age at diagnosis was 68.5 years and male:female ratio was 3.6/1.00. The average time after diagnosis to stent placement was 220 days ± 408 SD; average time of follow-up after diagnosis was 280 days ± 404 SD. Average length of stricture was 5.9 ± 3.6 cm with the majority of the strictures (89%) located at/or distal to the mid-esophagus. 31/101 patients (31%) were alive at 60 days post stent placement. The mean pre-stent dysphagia score was 3, 1.5 at 48 h. and 1.2 at 30 days post-stent. There was a significant improvement (p<0.01) at 48 h. and 30 days after stent placement. The complication rate at the time of stent placement was 12%; 24/100 (24%) at 48 h. and 32/95 (34%) after 48 h. Immediate complications included: failure to deploy - 3; difficulty removing the stent catheter system - 3; perforation - 2; aspiration - 1; inadequate placement -1; and unspecified - 2. Complications at 48 h, included moderate/severe pain 15 (15%); aspiration 3 (3%), nausea & vomiting 3 (3%); GI bleed 2 (2%) and stent migration 2 (2%). Complications beyond the 48-hour period were: moderate/severe pain 14 (14%); GI bleed 9 (9%); tumor overgrowths (5%); aspiration 2 (2%) and stent migration 1 (1%). CONCLUSION: 1) Self-expanding, silicone-covered WALLSTENT results in significant improvement in dysphagia; 2) immediate placement complications occur in 12% of patients; 3) pain is the most frequent complication (15%) at 48 h. and beyond; 4) stent migration occurs in 3% of patients and tumor overgrowth occurs in 5%. SUMMARY: WALLSTENTS offer excellent palliation of dysphagia with acceptable morbidity and mortality rate.

AB - Palliation of esophageal carcinoma has included esophageal prosthesis insertion. Recently, a self-expanding, silicone-covered, WALLSTENT has been introduced. The purpose of this nation-wide, post-market surveillance study was to evaluate the safety, efficacy and morbidity associated with this new stent. METHODS: Survey forms were sent to 56 gastroenterologists who had placed WALLSTENTS. The completed forms were tabulated by MedProbe™, Inc. Demographic data, symptomatology and treatments preand post stent placement as well as morbidity and mortality at 0, 30, and 60 days were analyzed. Dysphagia scores were: 0 - no dysphagia; 1 - solids; 2 - semi-solids; 3 - liquids and 4 -unable to swallow. RESULTS: 101 (27%) forms were returned; the patients' mean age at diagnosis was 68.5 years and male:female ratio was 3.6/1.00. The average time after diagnosis to stent placement was 220 days ± 408 SD; average time of follow-up after diagnosis was 280 days ± 404 SD. Average length of stricture was 5.9 ± 3.6 cm with the majority of the strictures (89%) located at/or distal to the mid-esophagus. 31/101 patients (31%) were alive at 60 days post stent placement. The mean pre-stent dysphagia score was 3, 1.5 at 48 h. and 1.2 at 30 days post-stent. There was a significant improvement (p<0.01) at 48 h. and 30 days after stent placement. The complication rate at the time of stent placement was 12%; 24/100 (24%) at 48 h. and 32/95 (34%) after 48 h. Immediate complications included: failure to deploy - 3; difficulty removing the stent catheter system - 3; perforation - 2; aspiration - 1; inadequate placement -1; and unspecified - 2. Complications at 48 h, included moderate/severe pain 15 (15%); aspiration 3 (3%), nausea & vomiting 3 (3%); GI bleed 2 (2%) and stent migration 2 (2%). Complications beyond the 48-hour period were: moderate/severe pain 14 (14%); GI bleed 9 (9%); tumor overgrowths (5%); aspiration 2 (2%) and stent migration 1 (1%). CONCLUSION: 1) Self-expanding, silicone-covered WALLSTENT results in significant improvement in dysphagia; 2) immediate placement complications occur in 12% of patients; 3) pain is the most frequent complication (15%) at 48 h. and beyond; 4) stent migration occurs in 3% of patients and tumor overgrowth occurs in 5%. SUMMARY: WALLSTENTS offer excellent palliation of dysphagia with acceptable morbidity and mortality rate.

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