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Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.

Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial.

Author information

1
Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
2
Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands.
3
Department of Gastroenterology and Hepatology, HAGA Hospital, den Haag, The Netherlands.
4
Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands.
5
Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.
6
Department of Biomedical Science, Humanitas University, Milano, Italy.
7
Department of Gastroenterology and Hepatology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium.
8
Department of Gastroenterology and Hepatology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
9
Division of Surgery and Interventional Science, University College London Hospital, London, United Kingdom.
10
Department of Gastroenterology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
11
Department of Gastroenterology, University College London Hospital, London, United Kingdom.
12
Cook Research Incorporated, West Lafayette, Indiana, United States.
13
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.

Abstract

BACKGROUND:

Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared.

METHODS:

This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity.

RESULTS:

At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; P = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months (P < 0.001).

CONCLUSION:

Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01337206.

PMID:
29883979
DOI:
10.1055/a-0602-4169

Conflict of interest statement

This study was sponsored by Cook Medical. FP Vleggaar is a consultant for Boston Scientific. A Repici is a consultant for Boston Scientific and has received research fees from Fujifilm Europe, Norgine Europe, and Ferring. PH Deprez is a consultant for Boston Scientific and Olympus. BL Weusten has received consultancy fees from Boston Scientific, and research support from Boston Scientific and C2Therapeutics. R Bisschops has received: consultancy fees from Boston Scientific; speaker fees from Covidien and Norgine; speaker fees and hands-on training sponsorship from Olympus Europe; consultancy fees, speaker fee, and research support from Pentax Europe and Fujifilm; research support from Cook Medical; hands-on training sponsorship from Erbe; and an editorial fee from Thieme Verlag as Co-Editor of Endoscopy. R Haidry has received unrestricted educational grants from Pentax Medical and Cook Endoscopy. KJ Sanborn and EE O’Leary are paid employees of Cook Research Incorporated, a contract research organization and Cook Group Company. JE van Hooft has received research grants from Cook Medical and Abbott, and is a consultant for Boston Scientific and Covidien. PD Siersema is Editor-in-Chief of Endoscopy and has received research grants from Boston Scientific and Cook Medical, and is a consultant for Boston Scientific and Ella-CS.

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