The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study
Abstract 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; h...
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| Format: | Article |
| Language: | English |
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BMC
2021-06-01
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| Series: | BMC Neurology |
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| Online Access: | https://doi.org/10.1186/s12883-021-02269-7 |
| _version_ | 1818823269582635008 |
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| author | Kanefumi Yamashita Yukinori Yube Yukinao Yamazaki Takehide Fukuchi Masaki Kato Tomoyuki Koike Takeshi Uehara Yoshiou Ikeda Satoshi Furune Hidehiro Murakami Eiji Kubota Shinsuke Fujioka Yoshinori Sato Xiaoyi Jin Tomohiko Suzuki Kazuhiro Furukawa Yoshio Tsuboi |
| author_facet | Kanefumi Yamashita Yukinori Yube Yukinao Yamazaki Takehide Fukuchi Masaki Kato Tomoyuki Koike Takeshi Uehara Yoshiou Ikeda Satoshi Furune Hidehiro Murakami Eiji Kubota Shinsuke Fujioka Yoshinori Sato Xiaoyi Jin Tomohiko Suzuki Kazuhiro Furukawa Yoshio Tsuboi |
| author_sort | Kanefumi Yamashita |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-18T23:37:18Z |
| format | Article |
| id | doaj.art-3063790ee23e461ebcfbe86d06524d0d |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-12-18T23:37:18Z |
| publishDate | 2021-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-3063790ee23e461ebcfbe86d06524d0d2022-12-21T20:47:30ZengBMCBMC Neurology1471-23772021-06-012111710.1186/s12883-021-02269-7The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational studyKanefumi Yamashita0Yukinori Yube1Yukinao Yamazaki2Takehide Fukuchi3Masaki Kato4Tomoyuki Koike5Takeshi Uehara6Yoshiou Ikeda7Satoshi Furune8Hidehiro Murakami9Eiji Kubota10Shinsuke Fujioka11Yoshinori Sato12Xiaoyi Jin13Tomohiko Suzuki14Kazuhiro Furukawa15Yoshio Tsuboi16Department of Gastroenterological Surgery, Seizan-Kai Kawaminami HospitalDepartment of Gastroenterology and Minimally Invasive Surgery, Juntendo University HospitalDepartment of Gastroenterology, Fukui Red Cross HospitalDivision of Endoscopy, Yokohama City University Medical CenterDivision of Gastroenterology and Hepatology, Department of Internal Medicine, St Marianna University School of MedicineDivision of Gastroenterology, Tohoku University Graduate School of MedicineDepartment of Gastroenterology, Saitama Medical Center, Jichi Medical UniversityDepartment of Gastroenterology and Metabology, Ehime University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of MedicineDepartment of Internal Medicine, Saiseikai Matsuyama HospitalDepartment of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical SciencesDepartment of Neurology, Fukuoka UniversityDivision of Gastroenterology and Hepatology, Department of Internal Medicine, St Marianna University School of MedicineDivision of Gastroenterology, Tohoku University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of MedicineDepartment of Neurology, Fukuoka UniversityAbstract 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.https://doi.org/10.1186/s12883-021-02269-7Levodopa–carbidopa intestinal gelParkinson’s diseasePercutaneous endoscopic gastrojejunostomy |
| spellingShingle | Kanefumi Yamashita Yukinori Yube Yukinao Yamazaki Takehide Fukuchi Masaki Kato Tomoyuki Koike Takeshi Uehara Yoshiou Ikeda Satoshi Furune Hidehiro Murakami Eiji Kubota Shinsuke Fujioka Yoshinori Sato Xiaoyi Jin Tomohiko Suzuki Kazuhiro Furukawa Yoshio Tsuboi The impact of tube replacement timing during LCIG therapy on PEG-J associated adverse events: a retrospective multicenter observational study BMC Neurology Levodopa–carbidopa intestinal gel Parkinson’s disease Percutaneous endoscopic gastrojejunostomy |
| 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 | Levodopa–carbidopa intestinal gel Parkinson’s disease Percutaneous endoscopic gastrojejunostomy |
| url | https://doi.org/10.1186/s12883-021-02269-7 |
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