American Journal of Gastroenterology ISSN 0002-9270 C  2007 by Am. Coll. of Gastroenterology doi: 10.1111/j.1572-0241.2007.01565.x Published by Blackwell Publishing A Randomized Prospective Comparison of Self-Expandable Plastic Stents and Partially Covered Self-Expandable Metal Stents in the Palliation of Malignant Esophageal Dysphagia Massimo Conio, M.D., 1 Alessandro Repici, M.D., 2 Giorgio Battaglia, M.D., 3 Giovanni De Pretis, M.D., 4 Luigi Ghezzo, M.D., 5 Max Bittinger, M.D., 6 Helmut Messmann, M.D., 6 Jean-Fran¸ cois Demarquay, M.D., 7 Sabrina Blanchi, M.S., 1 Michele Togni, M.D., 4 Rita Conigliaro, M.D., 8 and Rosangela Filiberti, Ph.D. 9 1 Department of Gastroenterology, Sanremo Hospital, Sanremo, Italy; 2 Department of Digestive Endoscopy, Istituto Clinico Humanitas, Rozzano, Italy; 3 Department of Medical and Surgical Sciences, University of Padova, Padova, Italy; 4 Department of Gastroenterology, S. Chiara Hospital, Trento, Italy; 5 Department of Gastroenterology, S. Croce e Carle Hospital, Cuneo, Italy; 6 Department of Internal Medicine III, Zentralklinikum Augsburg, Germany; 7 Department of Gastroenterology, Archet II, University Hospital, Nice, France; 8 Department of Digestive Endoscopy, Arcispedale S. Maria Nuova, Reggio Emilia, Italy; and 9 Department of Epidemiology and Biostatistics, National Institute for Cancer Research, Genova, Italy 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. (Am J Gastroenterol 2007;102:2667–2677) INTRODUCTION Patients with esophageal carcinoma have an ominous prog- nosis; almost 50% at the time of diagnosis have advanced disease beyond any curative approach (1). The 5-yr overall survival rate for esophageal carcinoma is 10–15% (2). Dys- phagia is the most distressing symptom in esophageal cancer, causing severe undernutrition (3). The main aim of endoscopic palliation is to improve swal- lowing. The optimal procedure would avoid relapsing dys- phagia requiring reintervention, while minimizing the length of hospital stay and treatment costs. The use of self-expanding metal stents (SEMS) for palliation of inoperable malignant dysphagia is well established. SEMS placement may provide better palliation and fewer complications compared to plas- tic stents (4). However, currently available SEMS still have drawbacks including risk of migration (for covered SEMS), malignant or granulomatous ingrowth through the stent mesh or overgrowth at the stent ends, difﬁculties in stent removal or repositioning, and high cost (5). Although Homs et al. (6) reported that single-dose brachytherapy (12 Gy) carried a lower risk of recurrent 2667