Endoscopy 2018; 50(12): 1146-1155
DOI: 10.1055/a-0602-4169
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Daisy Walter
 1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
,
Maarten W. van den Berg
 2   Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands
 3   Department of Gastroenterology and Hepatology, HAGA Hospital, den Haag, The Netherlands
,
Meike M. Hirdes
 4   Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands
,
Frank P. Vleggaar
 1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
,
Alessandro Repici
 5   Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy
 6   Department of Biomedical Science, Humanitas University, Milano, Italy
,
Pierre H. Deprez
 7   Department of Gastroenterology and Hepatology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium
,
Bartolomé L. Viedma
 8   Department of Gastroenterology and Hepatology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
,
Laurence B. Lovat
 9   Division of Surgery and Interventional Science, University College London Hospital, London, United Kingdom
,
Bas L. Weusten
 4   Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands
,
Raf Bisschops
10   Department of Gastroenterology, University Hospitals Leuven, KU Leuven, Leuven, Belgium
,
Rehan Haidry
11   Department of Gastroenterology, University College London Hospital, London, United Kingdom
,
Elisa Ferrara
 5   Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy
,
Keith J. Sanborn
12   Cook Research Incorporated, West Lafayette, Indiana, United States
,
Erin E. O’Leary
12   Cook Research Incorporated, West Lafayette, Indiana, United States
,
Jeanin E. van Hooft
 2   Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands
,
Peter D. Siersema
 1   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
13   Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands
› Institutsangaben
TRIAL REGISTRATION: This study is a multicenter, randomized trial.NCT01337206 at clinicaltrials.gov
Weitere Informationen

Publikationsverlauf

submitted 20. Oktober 2017

accepted after revision 14. März 2018

Publikationsdatum:
08. Juni 2018 (online)

Preview

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.

Supplementary Table e1