TY - JOUR
T1 - A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia
AU - Conio, Massimo
AU - Repici, Alessandro
AU - Battaglia, Giorgio
AU - De Pretis, Giovanni
AU - Ghezzo, Luigi
AU - Bittinger, Max
AU - Messmann, Helmut
AU - Demarquay, Jean François
AU - Blanchi, Sabrina
AU - Togni, Michele
AU - Conigliaro, Rita
AU - Filiberti, Rosangela
PY - 2007/12
Y1 - 2007/12
N2 - OBJECTIVES: 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.
AB - OBJECTIVES: 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.
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U2 - 10.1111/j.1572-0241.2007.01565.x
DO - 10.1111/j.1572-0241.2007.01565.x
M3 - Article
C2 - 18042102
AN - SCOPUS:36549027847
VL - 102
SP - 2667
EP - 2677
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
SN - 0002-9270
IS - 12
ER -