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CC BY-NC-ND 4.0 · Endoscopy
DOI: 10.1055/a-2342-1140
Original article

A comparison of novel electrocautery-enhanced lumen-apposing metal stents and plastic stents in endoscopic ultrasound-guided drainage of infected walled-off necrosis: a multicenter randomized study

Jong Ho Moon
1   Division of Gastroenterology, Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, Korea (the Republic of)
,
Se Woo Park 
2   Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea (the Republic of)
,
Yun Nah Lee
1   Division of Gastroenterology, Department of Internal Medicine, SoonChunHyang University College of Medicine, Bucheon, Korea (the Republic of)
,
Sang Hyub Lee 
3   Division of Gastroenterology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of)
,
Seong-Hun Kim
4   Department of Internal Medicine, Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Korea (the Republic of)
,
Dong Wook Lee
5   Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea (the Republic of)
,
Chang Min Cho
5   Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea (the Republic of)
,
Sung Bum Kim
6   Division of Gastroenterology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea (the Republic of)
,
Chan Hyuk Park 
7   Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea (the Republic of)
› Author AffiliationsSupported by: SoonChunHyang University Research Fund J.H.M.

Clinical Trial: Registration number (trial ID): KCT0004087, Trial registry: Clinical Research Information Service, Republic of Korea (https://cris.nih.go.kr), Type of Study: Prospective, Randomized, Multi-Center Study
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Interpreting studies comparing lumen-apposing metal stents and plastic stents for walled-off necrosis: wisdom is the need of the hourEndoscopy eFirst
DOI: 10.1055/a-2368-0784

Abstract

Background Although lumen-apposing metal stents (LAMSs) have been increasingly used for walled-off necrosis (WON), their advantages over plastic stents in infected WON are unclear. We investigated the safety and efficacy of a novel electrocautery-enhanced LAMS for managing infected WON.

Methods Patients who required endoscopic ultrasound-guided WON drainage were randomly assigned to LAMS or plastic stent groups. The primary outcome was total number of direct endoscopic necrosectomy (DEN) procedures required to achieve clinical success. Secondary outcomes included rates of technical success, clinical success, and adverse events.

Results 46 patients were included in the LAMS (n = 23) and plastic stent (n = 23) groups. The median total number of DEN procedures did not differ significantly between the plastic stent group (4 procedures, interquartile range [IQR] 2.5–5.0) and LAMS group (9 procedures, IQR 8.0–9.0) (P = 0.07). The LAMS group demonstrated a significantly higher clinical success rate than the plastic stent group based on intention-to-treat analysis (100% vs. 73.9%, P =0.03) at 8 weeks but not at 4 weeks. Significant bleeding occurred in one patient in the plastic stent group and no patients in the LAMS group.

Conclusions We found no significant difference in the total number of DEN procedures between LAMSs and plastic stents for managing infected WON. The only statistically significant finding was a higher clinical success rate at 8 weeks for patients treated with LAMS. The use of LAMS did not result in any adverse events, such as bleeding or buried LAMS syndrome, within the study duration.

Supplementary Material



Publication History

Received: 24 December 2023

Accepted after revision: 07 June 2024

Accepted Manuscript online:
10 June 2024

Article published online:
07 August 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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