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The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study
BACKGROUND: Levodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however,...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8228941/ https://www.ncbi.nlm.nih.gov/pubmed/34172002 http://dx.doi.org/10.1186/s12883-021-02269-7 |
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author | Yamashita, Kanefumi Yube, Yukinori Yamazaki, Yukinao Fukuchi, Takehide Kato, Masaki Koike, Tomoyuki Uehara, Takeshi Ikeda, Yoshiou Furune, Satoshi Murakami, Hidehiro Kubota, Eiji Fujioka, Shinsuke Sato, Yoshinori Jin, Xiaoyi Suzuki, Tomohiko Furukawa, Kazuhiro Tsuboi, Yoshio |
author_facet | Yamashita, Kanefumi Yube, Yukinori Yamazaki, Yukinao Fukuchi, Takehide Kato, Masaki Koike, Tomoyuki Uehara, Takeshi Ikeda, Yoshiou Furune, Satoshi Murakami, Hidehiro Kubota, Eiji Fujioka, Shinsuke Sato, Yoshinori Jin, Xiaoyi Suzuki, Tomohiko Furukawa, Kazuhiro Tsuboi, Yoshio |
author_sort | Yamashita, Kanefumi |
collection | PubMed |
description | BACKGROUND: Levodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however, reports on their treatment have been limited. This is the first multicenter study to clarify the frequency and timing of device-related AEs. METHODS: Between September 2016 and December 2018, 104 patients introduced to the LCIG treatment for advanced PD in 11 hospitals were included. The patients’ characteristics, AEs incidence, AEs time, and tube exchange time were investigated. RESULTS: The median follow-up period was 21.5 months. Minor AE cases were 29.4%, whereas major AE cases were 43.1%. Majority of major AEs (n = 55, 94.8%) were managed with endoscopic treatment, such as tube exchange. Few severe AEs required surgical treatment (n =3, 5.2%). The mean (range) exposure to percutaneous endoscopic gastrojejunostomy (PEG-J) was 14.7 (0–33) months. One year after the LCIG treatment introduction, 55 patients (54.0%) retained the original PEG-J tube. The mean PEG-J tube exchange time was 10.8 ± 7.0 months in all patients, 11.6 ± 4.7 and 10.5 ± 7.7 months in patients with scheduled exchange and who underwent exchange due to AEs, respectively. CONCLUSIONS: Some device-related AEs occurred during the LCIG treatment; however, only few were serious, most of which could be treated with simple procedures or tube replacement with endoscopy. Therefore, the LCIG treatment is feasible and safe and is a unique treatment option for PD, requiring endoscopists’ understanding and cooperation. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02269-7. |
format | Online Article Text |
id | pubmed-8228941 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82289412021-06-28 The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study Yamashita, Kanefumi Yube, Yukinori Yamazaki, Yukinao Fukuchi, Takehide Kato, Masaki Koike, Tomoyuki Uehara, Takeshi Ikeda, Yoshiou Furune, Satoshi Murakami, Hidehiro Kubota, Eiji Fujioka, Shinsuke Sato, Yoshinori Jin, Xiaoyi Suzuki, Tomohiko Furukawa, Kazuhiro Tsuboi, Yoshio BMC Neurol Research BACKGROUND: Levodopa–carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson’s disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however, reports on their treatment have been limited. This is the first multicenter study to clarify the frequency and timing of device-related AEs. METHODS: Between September 2016 and December 2018, 104 patients introduced to the LCIG treatment for advanced PD in 11 hospitals were included. The patients’ characteristics, AEs incidence, AEs time, and tube exchange time were investigated. RESULTS: The median follow-up period was 21.5 months. Minor AE cases were 29.4%, whereas major AE cases were 43.1%. Majority of major AEs (n = 55, 94.8%) were managed with endoscopic treatment, such as tube exchange. Few severe AEs required surgical treatment (n =3, 5.2%). The mean (range) exposure to percutaneous endoscopic gastrojejunostomy (PEG-J) was 14.7 (0–33) months. One year after the LCIG treatment introduction, 55 patients (54.0%) retained the original PEG-J tube. The mean PEG-J tube exchange time was 10.8 ± 7.0 months in all patients, 11.6 ± 4.7 and 10.5 ± 7.7 months in patients with scheduled exchange and who underwent exchange due to AEs, respectively. CONCLUSIONS: Some device-related AEs occurred during the LCIG treatment; however, only few were serious, most of which could be treated with simple procedures or tube replacement with endoscopy. Therefore, the LCIG treatment is feasible and safe and is a unique treatment option for PD, requiring endoscopists’ understanding and cooperation. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02269-7. BioMed Central 2021-06-25 /pmc/articles/PMC8228941/ /pubmed/34172002 http://dx.doi.org/10.1186/s12883-021-02269-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Yamashita, Kanefumi Yube, Yukinori Yamazaki, Yukinao Fukuchi, Takehide Kato, Masaki Koike, Tomoyuki Uehara, Takeshi Ikeda, Yoshiou Furune, Satoshi Murakami, Hidehiro Kubota, Eiji Fujioka, Shinsuke Sato, Yoshinori Jin, Xiaoyi Suzuki, Tomohiko Furukawa, Kazuhiro Tsuboi, Yoshio The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title | The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title_full | The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title_fullStr | The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title_full_unstemmed | The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title_short | The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study |
title_sort | impact of tube replacement timing during lcig therapy on peg-j associated adverse events: a retrospective multicenter observational study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8228941/ https://www.ncbi.nlm.nih.gov/pubmed/34172002 http://dx.doi.org/10.1186/s12883-021-02269-7 |
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