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.
Conio
Massimo
M
Department of Gastroenterology, Sanremo Hospital, Sanremo, Italy.
Repici
Alessandro
A
Battaglia
Giorgio
G
De Pretis
Giovanni
G
Ghezzo
Luigi
L
Bittinger
Max
M
Messmann
Helmut
H
Demarquay
Jean-François
JF
Blanchi
Sabrina
S
Togni
Michele
M
Conigliaro
Rita
R
Filiberti
Rosangela
R
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