Abstract | 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 | Alessandro Repici, Frank P Vleggaar, Cesare Hassan, Petra G van Boeckel, Fabio Romeo, Nicola Pagano, Alberto Malesci, Peter D Siersema |
Journal | Gastrointestinal endoscopy
(Gastrointest Endosc)
Vol. 72
Issue 5
Pg. 927-34
(Nov 2010)
ISSN: 1097-6779 [Electronic] United States |
PMID | 21034894
(Publication Type: Clinical Trial, Journal Article)
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Copyright | Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved. |
Chemical References |
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Topics |
- 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
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