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.
RCT Entities:
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.
Authors: Valter N Felix; Alaor Caetano; Jose P Cipullo; Emiliano C Almodova; Wagner Colaiacovo; Aldenir F Zamboti Journal: BMC Res Notes Date: 2011-11-10