| Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. | |
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MedLine Citation:
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PMID: 21034894 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. OBJECTIVE: To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs). DESIGN AND SETTING: Prospective study from 2 European endoscopy centers. PATIENTS AND INTERVENTION: Twenty-one patients (11 men/10 women, mean age 60.2 ± 17.6 years) with RBESs defined according to the Kochman criteria treated by placement of a biodegradable stent (Ella stent). MAIN OUTCOME MEASUREMENTS: Clinical and endoscopic follow-up was scheduled at 1, 2, 3, and 6 months and later only in case of dysphagia recurrence. Pre- and poststenting dysphagia status was graded according to a 5-point scale. Minor and major complication rates were prospectively assessed. RESULTS: Stent insertion was technically successful in all of the patients. At 4 and 7 weeks, stent migration occurred in 2 patients (9.5%). At 3-month endoscopy, the stent appeared to be almost completely fragmented in all remaining patients. The median pre- and poststenting dysphagia scores were 3 (range 3-4) and 1 (range 0-2), respectively (P < .01), with a median follow-up of 53 weeks (range 25-88 weeks). In detail, 9 of 20 patients (45%) were dysphagia free at the end of the follow-up. No major complications occurred. Severe poststenting pain requiring analgesics developed in 3 patients, and minor bleeding was observed in 1 patient. LIMITATIONS: Limited follow-up; nonrandomized study. CONCLUSIONS: In this preliminary study, the biodegradable stent showed a favorable risk/benefit ratio, achieving complete relief of dysphagia in nearly 50% of RBES patients without the occurrence of major complications. The use of this stent may be a valuable alternative to repeat endoscopic dilation. Larger studies with longer follow-up are needed. |
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Authors:
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Alessandro Repici; Frank P Vleggaar; Cesare Hassan; Petra G van Boeckel; Fabio Romeo; Nicola Pagano; Alberto Malesci; Peter D Siersema |
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Publication Detail:
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Type: Clinical Trial; Journal Article |
Journal Detail:
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Title: Gastrointestinal endoscopy Volume: 72 ISSN: 1097-6779 ISO Abbreviation: Gastrointest. Endosc. Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-11-01 Completed Date: 2011-04-19 Revised Date: 2011-04-26 |
Medline Journal Info:
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Nlm Unique ID: 0010505 Medline TA: Gastrointest Endosc Country: United States |
Other Details:
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Languages: eng Pagination: 927-34 Citation Subset: IM |
Copyright Information:
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Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. |
Affiliation:
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Department of Gastroenterology, IRCCS Istituto Clinico Humanitas, Milan, Italy. alessandro.repici@humanitas.it |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Absorbable Implants* Adult Aged Cohort Studies Deglutition Disorders / etiology, pathology, prevention & control Endoscopy, Gastrointestinal* Equipment Design Esophageal Stenosis / etiology, pathology, therapy* Female Humans Male Middle Aged Polydioxanone* Stents* Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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PB-PG-1208-17025//Department of Health |
| Chemical | |
Reg. No./Substance:
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31621-87-1/Polydioxanone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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