A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia.
OBJECTIVE
Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex).


METHODS
One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N=47) or a partially covered Ultraflex (N=54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded.


RESULTS
Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P=NS).


CONCLUSIONS
No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.
Department of Gastroenterology, Sanremo Hospital, Sanremo, Italy.
Massimo
M
Conio
Alessandro
A
Repici
Giorgio
G
Battaglia
Giovanni
G
De Pretis
Luigi
L
Ghezzo
Max
M
Bittinger
Helmut
H
Messmann
Jean-François
JF
Demarquay
Sabrina
S
Blanchi
Michele
M
Togni
Rita
R
Conigliaro
Rosangela
R
Filiberti
D000230:Adenocarcinoma / Q000150:complications / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D004938:Esophageal Neoplasms / Q000150:complications / Q000628:therapy*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D010166:Palliative Care; D011091:Polyesters; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D008670:Metals; D011091:Polyesters