N. Bethge

BACKGROUND: Esophageal obstruction due to cancer can produce debilitating dysphagia. Rapid palliation is usually possible with endoscopic placement of a plastic esophageal prosthesis, but this device has a high rate of complications. A new alternative is a metal-mesh stent that collapses to 3 mm in diameter at placement but can then expand up to 16 mm. METHODS: Patients with esophageal carcinoma (39 patients) or malignant extrinsic obstruction (3 patients) were randomly assigned to treatment with either a plastic prosthesis (16 mm in diameter) or an expansile metal-mesh stent. The patients were evaluated every six weeks until death. The degree of palliation was expressed as a dysphagia score and a Karnofsky performance score. RESULTS: Complications were significantly less frequent with the metal stents than with the plastic prostheses (no complications vs. nine; P < 0.001). The dysphagia and Karnofsky scores improved significantly and to a similar degree in both treatment groups. The most common causes of recurrent dysphagia were migration of the plastic prostheses (five patients) and ingrowth or overgrowth of the metal stents by tumor (five patients). The rates of reintervention were similar in both treatment groups, as were the 30-day mortality rates. The period of hospitalization after placement of a prosthesis was significantly longer in the group given plastic prostheses than in the group given metal stents (mean +/- SE, 12.5 +/- 2.1 vs. 5.4 +/- 1.0 days; P = 0.005). Despite their higher initial cost, the metal stents were cost effective because of the absence of fatal complications and the decrease in the hospital stay. CONCLUSIONS: Expansile metal stents are a safe and cost-effective alternative to conventional plastic endoprostheses in the treatment of esophageal obstruction due to inoperable cancer.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

OBJECTIVES: Esophagorespiratory fistulas are serious complications of malignant disease in the esophagus and are associated with rapid deterioration and death. Palliation has thus far consisted of insertion of a plastic stent to occlude the fistula opening. Insertion of these stents is associated with a high complication rate. Our aims were to study the efficacy of a new class of metal stents covered with a membrane with regard to fistula occlusion and lumen patency. METHODS: Six consecutive patients with esophagorespiratory fistulas were treated with covered expandable metal stents. RESULTS: In all six patients, no evidence of persisting fistula was seen on contrast radiographs 2 h after stent placement. All patients were able to eat a normal diet after stent insertion and had complete occlusion of their esophagorespiratory fistula. One patient reported pain after the procedure, and the symptoms persisted until death. One patient died of massive hematemesis 5 days after the procedure. Dysphagia scores improved in all patients from a median of 4 to a median of 1, and the Karnofsky score improved from a median of 40% to a median of 65%. Fistulas remained closed until death in all patients. CONCLUSIONS: Covered expandable metal stents are safe and effective in the palliation of esophagorespiratory fistulas.