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      A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study

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          Abstract

          Background

          Refractory benign esophageal strictures (RBESs) have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs), biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs), for the treatment of RBES.

          Methods

          This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10), biodegradable stents (n = 10) or FCSEMSs (12 weeks, n = 10). Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions.

          Results

          Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60%) in the SEPS group, 2 (20%) in the biodegradable group and 3 (30%) in the FCSEMS group ( P = 0.16). A total of 8/30 patients (26.6%) were dysphagia-free after the end of follow-up: 1 (10%) in the SEPS group, 3 (30%) in the biodegradable group and 4 (40%) in the FCSEMS group ( P = 0.27). More reinterventions were required in the SEPS group (n = 24) than in the biodegradable group (n = 13) or the FCSEMS group (n = 13) ( P = 0.24). Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011).

          Conclusions

          Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence.

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          Most cited references28

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          A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer.

          Esophageal obstruction due to cancer can produce debilitating dysphagia. Rapid palliation is usually possible with endoscopic placement of a plastic esophageal prosthesis, but this device has a high rate of complications. A new alternative is a metal-mesh stent that collapses to 3 mm in diameter at placement but can then expand up to 16 mm. Patients with esophageal carcinoma (39 patients) or malignant extrinsic obstruction (3 patients) were randomly assigned to treatment with either a plastic prosthesis (16 mm in diameter) or an expansile metal-mesh stent. The patients were evaluated every six weeks until death. The degree of palliation was expressed as a dysphagia score and a Karnofsky performance score. Complications were significantly less frequent with the metal stents than with the plastic prostheses (no complications vs. nine; P < 0.001). The dysphagia and Karnofsky scores improved significantly and to a similar degree in both treatment groups. The most common causes of recurrent dysphagia were migration of the plastic prostheses (five patients) and ingrowth or overgrowth of the metal stents by tumor (five patients). The rates of reintervention were similar in both treatment groups, as were the 30-day mortality rates. The period of hospitalization after placement of a prosthesis was significantly longer in the group given plastic prostheses than in the group given metal stents (mean +/- SE, 12.5 +/- 2.1 vs. 5.4 +/- 1.0 days; P = 0.005). Despite their higher initial cost, the metal stents were cost effective because of the absence of fatal complications and the decrease in the hospital stay. Expansile metal stents are a safe and cost-effective alternative to conventional plastic endoprostheses in the treatment of esophageal obstruction due to inoperable cancer.
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            Role of esophageal stents in benign and malignant diseases.

            These recommendations provide an evidence-based approach to the role of esophageal stents in the management of benign and malignant diseases. These guidelines have been developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the Board of Trustees. The following guidelines are based on a critical review of the available scientific literature on the topic identified in Medline and PubMed (January 1992-December 2008) using search terms that included stents, self-expandable metal stents, self-expandable plastic stents, esophageal cancer, esophageal adenocarcinoma, esophageal squamous cell carcinoma, esophageal stricture, perforations, anastomotic leaks, tracheoesophageal fistula, and achalasia. These guidelines are intended for use by health-care providers and apply to adult, but not pediatric, patients. As with other practice guidelines, these guidelines are not intended to replace clinical judgment but rather to provide general guidelines applicable to the majority of patients. Clinicians need to integrate recommendations with their own clinical judgment, and with individual patient circumstances, values, and preferences. They are intended to be flexible, in contrast to standards of care, which are inflexible policies designed to be followed in every case. Specific recommendations are based on relevant published information. The quality of evidence and strength of recommendations have been assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, which is a system that has been adopted by multiple national and international societies. The GRADE system is based on a sequential assessment of quality of evidence, followed by assessment of the balance between benefits vs. downsides (harms, burden, and costs) and subsequent judgment regarding the strength of recommendation.
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              Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study.

              Benign esophageal strictures refractory to standard dilation therapy present a challenging problem. Temporary plastic and metal stents have been proposed with inconclusive results. To evaluate the efficacy and safety of a new biodegradable stent for the treatment of refractory benign esophageal strictures (RBESs). Prospective study from 2 European endoscopy centers. 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). 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. 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. Limited follow-up; nonrandomized study. 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. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
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                Author and article information

                Journal
                BMC Gastroenterol
                BMC Gastroenterol
                BMC Gastroenterology
                BioMed Central
                1471-230X
                2012
                12 June 2012
                : 12
                : 70
                Affiliations
                [1 ]Department of Gastroenterology, Pulido Valente Hospital, Faculty of Medical Sciences, Alameda das Linhas de Torres n° 117, 1769-001, Lisbon, Portugal
                [2 ]Center of Gastroenterology, Cuf Infanto Santo Hospital, Travessa do Castro n° 3, 1350-070, Lisbon, Portugal
                [3 ]Department of Gastroenterology, Santo António dos Capuchos Hospital, Alameda Santo António dos Capuchos, 1169-050, Lisbon, Portugal
                [4 ]Department of Gastroenterology, Garcia de Orta Hospital, Avenida Torrado da Silva, Pragal, 2801-951, Almada, Portugal
                [5 ]Catolica Lisbon School of Business & Economics, Palma de Cima, 1649-023, Lisbon, Portugal
                Article
                1471-230X-12-70
                10.1186/1471-230X-12-70
                3447662
                22691296
                ce35a7ed-7702-491b-8483-52e9334c8406
                Copyright ©2012 Canena et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 27 January 2012
                : 24 May 2012
                Categories
                Research Article

                Gastroenterology & Hepatology
                self-expanding plastic stents,refractory benign esophageal strictures,fully covered self-expanding metal stents,expandable esophageal stents,biodegradable stents

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