K. Knyrim et al., A CONTROLLED TRIAL OF AN EXPANSILE METAL STENT FOR PALLIATION OF ESOPHAGEAL OBSTRUCTION DUE TO INOPERABLE CANCER, The New England journal of medicine, 329(18), 1993, pp. 1302-1307
Background. Esophageal obstruction due to cancer can produce debilitat
ing dysphagia. Rapid palliation is usually possible with endoscopic pl
acement of a plastic esophageal prosthesis, but this device has a high
rate of complications. A new alternative is a metal-mesh stent that c
ollapses to 3 mm in diameter at placement but can then expand up to 16
mm. Methods. Patients with esophageal carcinoma (39 patients) or mali
gnant extrinsic obstruction (3 patients) were randomly assigned to tre
atment with either a plastic prosthesis (16 mm in diameter) or an expa
nsile metal-mesh stent. The patients were evaluated every six weeks un
til death. The degree of palliation was expressed as a dysphagia score
and a Karnofsky performance score. Results. Complications were signif
icantly less frequent with the metal stents than with the plastic pros
theses (no complications vs. nine; P<0.001). The dysphagia and Karnofs
ky scores improved significantly and to a similar degree in both treat
ment groups. The most common causes of recurrent dysphagia were migrat
ion of the plastic prostheses (five patients) and ingrowth or overgrow
th of the metal stents by tumor (five patients). The rates of reinterv
ention were similar in both treatment groups, as were the 30-day morta
lity rates. The period of hospitalization after placement of a prosthe
sis was significantly longer in the group given plastic prostheses tha
n 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 stent
s were cost effective because of the absence of fatal complications an
d the decrease in the hospital stay. Conclusions. Expansile metal sten
ts are a safe and cost-effective alternative to conventional plastic e
ndoprostheses in the treatment of esophageal obstruction due to inoper
able cancer.