New design esophageal stents for the palliation of dysphagia from esophageal or gastric cardia cancer: a randomized trial.
OBJECTIVE
Stents are often used for the palliation of inoperable esophageal or gastric cardia cancer. One of the drawbacks of the currently used stents is the high percentage of recurrent dysphagia due to stent migration and tissue growth. New stents have been designed to overcome this unwanted sequela of stent placement. In the present study, we investigated whether results of stent placement could be improved with newer stent designs.


METHODS
Between June 2004 and May 2006, 125 patients with dysphagia from inoperable carcinoma of the esophagus or gastric cardia were randomized to placement of an Ultraflex stent (N = 42), Polyflex stent (N = 41), or Niti-S stent (N = 42). Patients were followed by scheduled telephone calls at 14 days after treatment, and then monthly for 6 months or until death. Technical and functional outcome, complications, recurrent dysphagia, and survival were analyzed with, chi(2) tests, Kaplan-Meier curves, and log-rank tests.


RESULTS
Stent placement was technically successful in all patients with an Ultraflex stent, in 34/41 (83%) patients with a Polyflex stent, and in 40/42 (95%) patients treated with a Niti-S stent (P= 0.008). Dysphagia score improved from a median of 3 (liquids only) to 1 (ability to eat some solid food) in all patients. There were no differences in complications among the three stent types. Recurrent dysphagia, caused by tissue in- or overgrowth, migration, or food obstruction, was significantly different between patients with an Ultraflex stent and patients with a Polyflex stent or Niti-S stent (22 [52%]vs 15 [37%]vs 13 [31%], P= 0.03). Stent migration occurred more frequently with Polyflex stents, whereas tissue in- or overgrowth was more frequently seen with Ultraflex stents, and to a lesser degree, Niti-S stents. No differences were found in survival (median survival: Ultraflex stent 132 days vs Polyflex stent 102 days vs Niti-S stent 159 days) among the three stent types.


CONCLUSIONS
All three stents are safe and offer adequate palliation of dysphagia from esophageal or gastric cardia cancer. Nonetheless, Polyflex stents seem the least preferable in this patient group, as placement of this device is technically demanding and associated with a high rate of stent migrations.
Verschuur
Els M L
EM
Department of Gastroenterology & Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.
Repici
Alessandro
A
Kuipers
Ernst J
EJ
Steyerberg
Ewout W
EW
Siersema
Peter D
PD
D000368:Aged; D002299:Cardia; D003680:Deglutition Disorders / Q000209:etiology / Q000601:surgery*; D004867:Equipment Design; D004938:Esophageal Neoplasms / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D010166:Palliative Care; D012008:Recurrence; D015607:Stents; D013274:Stomach Neoplasms / Q000150:complications*