Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective, multicenter feasibility and safety study

Lieke M. Koggel*, Agnes N. Reijm, Marten A. Lantinga, Dirk J. de Jong, Eduardo Rodrigues-Pinto, Manon C.W. Spaander, Peter D. Siersema

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background and Aims:
A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy of the multisegmented FCSEMS.

Methods:
This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, defined as technically successful stent placement and dysphagia scores, and safety, defined as the number of adverse events (AEs) and serious AEs (SAEs), were measured.

Results:
The study was prematurely terminated due to safety concerns after including 23 patients (mean ± standard deviation age, 72 ± 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%).

Conclusions:
The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.)

Original languageEnglish
Pages (from-to)1027-1031.
Number of pages11
JournalGastrointestinal Endoscopy
Volume99
Issue number6
Early online date3 Feb 2024
DOIs
Publication statusPublished - Jun 2024

Bibliographical note

Publisher Copyright:
© 2024 American Society for Gastrointestinal Endoscopy

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