A Prospective, Randomized, Controlled Trial of Covered Expandable Metal Stents in The Palliation of Malignant Esophageal Obstruction at The Gastroesophageal Junction

Palliation of malignant esophageal obstruction is an important clinical problem. Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional pr...

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Veröffentlicht in:The American journal of gastroenterology 2001-06, Vol.96 (6), p.1791-1796
Hauptverfasser: Vakil, Nimish, Morris, Anthony I, Marcon, Norman, Segalin, Andrea, Peracchia, Alberto, Bethge, Norbert, Zuccaro, Gregory, Bosco, John J, Jones, Whitney F
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container_end_page 1796
container_issue 6
container_start_page 1791
container_title The American journal of gastroenterology
container_volume 96
creator Vakil, Nimish
Morris, Anthony I
Marcon, Norman
Segalin, Andrea
Peracchia, Alberto
Bethge, Norbert
Zuccaro, Gregory
Bosco, John J
Jones, Whitney F
description Palliation of malignant esophageal obstruction is an important clinical problem. Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial. Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months. One week after stenting the dysphagia score improved significantly in both the uncovered (n = 32, 3 ± 0.1 to 1 ± 0.1 [means ± SEMs], p < 0.001) and covered (n = 30, 3 ± 0.1 to 1 ± 0.2 [means ± SEMs], p < 0.001) stents. Obstructing tumor ingrowth was significantly more likely in the uncovered stent group (9/30) than in the covered group (1/32) (p = 0.005). Significant stent migration occurred in 2/30 patients with uncovered stents, as compared with 4/32 patients in the covered group (p = 0.44). Reinterventions for tumor ingrowth were significantly greater in the uncovered stent group (27%), as compared with 0% in the covered group (p = 0.002). Life table analysis showed similar survival in both groups. Membrane-covered stents have significantly better palliation than conventional bare metal stents because of decreased rates of tumor ingrowth that necessitate endoscopic reintervention for dysphagia.
doi_str_mv 10.1111/j.1572-0241.2001.03923.x
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Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial. Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months. 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Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial. Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months. 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Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial. Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months. One week after stenting the dysphagia score improved significantly in both the uncovered (n = 32, 3 ± 0.1 to 1 ± 0.1 [means ± SEMs], p &lt; 0.001) and covered (n = 30, 3 ± 0.1 to 1 ± 0.2 [means ± SEMs], p &lt; 0.001) stents. Obstructing tumor ingrowth was significantly more likely in the uncovered stent group (9/30) than in the covered group (1/32) (p = 0.005). Significant stent migration occurred in 2/30 patients with uncovered stents, as compared with 4/32 patients in the covered group (p = 0.44). Reinterventions for tumor ingrowth were significantly greater in the uncovered stent group (27%), as compared with 0% in the covered group (p = 0.002). Life table analysis showed similar survival in both groups. Membrane-covered stents have significantly better palliation than conventional bare metal stents because of decreased rates of tumor ingrowth that necessitate endoscopic reintervention for dysphagia.</abstract><cop>Oxford</cop><pub>.</pub><pmid>11419831</pmid><doi>10.1111/j.1572-0241.2001.03923.x</doi><tpages>6</tpages></addata></record>
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subjects Adenocarcinoma - complications
Aged
Biological and medical sciences
Deglutition Disorders - etiology
Deglutition Disorders - mortality
Deglutition Disorders - surgery
Esophageal Neoplasms - complications
Esophagogastric Junction - surgery
Gastroenterology
Humans
Intestinal Obstruction - etiology
Intestinal Obstruction - mortality
Intestinal Obstruction - surgery
Karnofsky Performance Status
Medical sciences
Palliative Care
Stents - adverse effects
Stomach, duodenum, intestine, rectum, anus
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Surgery of the digestive system
Survival Rate
Treatment Outcome
title A Prospective, Randomized, Controlled Trial of Covered Expandable Metal Stents in The Palliation of Malignant Esophageal Obstruction at The Gastroesophageal Junction
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