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

Daisy Walter; Maarten W. van den Berg; Meike M. Hirdes; Frank P. Vleggaar; Alessandro Repici; Pierre H. Deprez; Bartolomé L. Viedma; Laurence B. Lovat; Bas L. Weusten; Raf Bisschops; Rehan Haidry; Elisa Ferrara; Keith J. Sanborn; Erin E. O’Leary; Jeanin E. van Hooft; Peter D. Siersema

doi:10.1055/a-0602-4169

Endoscopy, Inhaltsverzeichnis

Endoscopy 2018; 50(12): 1146-1155
DOI: 10.1055/a-0602-4169

Original article

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

Authors

Daisy Walter

¹Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
Maarten W. van den Berg

²Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands

³Department of Gastroenterology and Hepatology, HAGA Hospital, den Haag, The Netherlands
Meike M. Hirdes

⁴Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands
Frank P. Vleggaar

¹Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
Alessandro Repici

⁵Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy

⁶Department of Biomedical Science, Humanitas University, Milano, Italy
Pierre H. Deprez

⁷Department of Gastroenterology and Hepatology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium
Bartolomé L. Viedma

⁸Department of Gastroenterology and Hepatology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
Laurence B. Lovat

⁹Division of Surgery and Interventional Science, University College London Hospital, London, United Kingdom
Bas L. Weusten

⁴Department of Gastroenterology, St. Antonius Hospital, Nieuwegein, The Netherlands
Raf Bisschops

¹⁰Department of Gastroenterology, University Hospitals Leuven, KU Leuven, Leuven, Belgium
Rehan Haidry

¹¹Department of Gastroenterology, University College London Hospital, London, United Kingdom
Elisa Ferrara

⁵Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy
Keith J. Sanborn

¹²Cook Research Incorporated, West Lafayette, Indiana, United States
Erin E. O’Leary

¹²Cook Research Incorporated, West Lafayette, Indiana, United States
Jeanin E. van Hooft

²Department of Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, The Netherlands
Peter D. Siersema

¹Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands

¹³Department 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.

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Referenzen

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