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

doi:10.1016/j.gie.2024.01.045

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

Gastrointest Endosc. 2024 Feb 3:S0016-5107(24)00089-0. doi: 10.1016/j.gie.2024.01.045. Online ahead of print.

Authors

Lieke M Koggel¹, Agnes N Reijm², Marten A Lantinga³, Dirk J de Jong⁴, Eduardo Rodrigues-Pinto⁵, Manon C W Spaander², Peter D Siersema⁶

Affiliations

¹ Department of Gastroenterology and Hepatology, Radboud Institute for Health Sciences, Radboud university medical center, Postbus 9101, 6500 HB Nijmegen, The Netherlands. Electronic address: lieke.koggel@radboudumc.nl.
² Department of Gastroenterology and Hepatology, Erasmus University Medical Center/Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
³ Department of Gastroenterology and Hepatology, Radboud Institute for Health Sciences, Radboud university medical center, Postbus 9101, 6500 HB Nijmegen, The Netherlands; Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands.
⁴ Department of Gastroenterology and Hepatology, Radboud Institute for Health Sciences, Radboud university medical center, Postbus 9101, 6500 HB Nijmegen, The Netherlands.
⁵ Department of Gastroenterology, Centro Hospitalar São João, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal.
⁶ Department of Gastroenterology and Hepatology, Radboud Institute for Health Sciences, Radboud university medical center, Postbus 9101, 6500 HB Nijmegen, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center/Erasmus MC Cancer Institute, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.

PMID: 38316224
DOI: 10.1016/j.gie.2024.01.045

Abstract

Background and aims: A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration that is seen in up to 30% of patients. We aimed to evaluate safety and efficacy of this 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 (serious) adverse events ((S)AEs) were measured.

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

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

Associated data

ClinicalTrials.gov/NCT04415463