Management of inoperable malignant oesophageal strictures with fully covered WallFlex(®) stent: a multicentre prospective study.

Humanitas Research Hospital, Rozzano, Milan, Italy. Electronic address: alessandro.repici@humanitas.it. Humanitas Research Hospital, Rozzano, Milan, Italy. Santa Chiara Hospital, Pisa, Italy. Civic Hospital, Palermo, Italy. Cremona Hospital, Cremona, Italy. Acireale Hospital, Acireale, Italy. Camposampiero Hospital, Italy. S. Orsola-Malphigi Hospital University of Bologna, Bologna, Italy. National Cancer Institute, G. Pascale Foundation - IRCCS, Naples, Italy. University Medical Center Utrecht, Utrecht, Netherlands.

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2014;(12):1093-8
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Abstract

BACKGROUND The majority of currently available oesophageal metal stents are partially covered to reduce migration risk. Preliminary experiences with fully covered stents seem to indicate an increased risk of migration in patients treated for malignant dysphagia. The aim of our study was to determine, in this setting, the safety and efficacy of a new, recently introduced stent with anti-migration proprieties. METHODS We designed a prospective, multicentre, non-randomized, follow-up study in nine tertiary referral centres. Eighty-two patients with dysphagia due to inoperable or metastatic oesophageal cancer were included. In all of them the fully covered WallFlex(®) stent was placed. Main outcome measurements included functional outcome, recurrent dysphagia, complications, and mortality. RESULTS Dysphagia score improved from a median of 3, before stenting, to 1 at 4 weeks after stent placement (P<0.001). Perforation occurred in 1 patient after 39 days, while bleeding was reported in 3. In total, 19 patients (23.1%) developed recurrent dysphagia because of stent migration (N=10, 12.2%), tissue overgrowth (N=7; 8.5%), and food impaction (N=2; 2.4%). CONCLUSIONS Placement of the fully covered WallFlex(®) stent resulted in safe and effective palliation of malignant dysphagia, with migration and tissue overgrowth rates comparable to previously reported data on partially covered stents.

Methodological quality

Publication Type : Clinical Trial ; Multicenter Study

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