UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040713 |
|---|---|
| Receipt number | R000046478 |
| Scientific Title | A study on tube replacement in patients with Parkinson's disease on Levodopa-Carbidopa Intestinal Gel (LCIG) therapy |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2021/06/11 13:17:42 |
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Basic information
Public title
A study on tube replacement in patients with Parkinson's disease on Levodopa-Carbidopa Intestinal Gel (LCIG) therapy
Acronym
A study on tube replacement in patients with Parkinson's disease on LCIG therapy
Scientific Title
A study on tube replacement in patients with Parkinson's disease on Levodopa-Carbidopa Intestinal Gel (LCIG) therapy
Scientific Title:Acronym
A study on tube replacement in patients with Parkinson's disease on LCIG therapy
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to collect information on PEG-J tube exchange that occurred during the LCIG operation and to verify its frequency, required time, and problems.
Basic objectives2
Others
Basic objectives -Others
Promotion of skill for handling PEG-J tubes without endoscopy
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of successful replacement of the PEG-J tube without endoscopy.
Key secondary outcomes
Type and incidence of complications associated with PEG-J tube replacement, time required for PEG-J tube replacement, and listing of reasons for not being able to replace a tube without endoscopy and the number of occurrences
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with Parkinson's disease on LCIG therapy in our hospital between October 2016 and April 2020, regardless of age or gender.
Key exclusion criteria
The subject has indicated that he/she will no longer participate in the study.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
ymukai@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
ymukai@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of NCNP
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
Tel
+81-42-341-2712
rinri-jimu@ncnp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncnp.go.jp/hospital/partnership/docs/3f768fb2da5beb3155ce300425ebcaa1358dc944.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2590112520300475
Number of participants that the trial has enrolled
19
Results
The mean participants age was 63.1 years, while the mean duration of Parkinson's disease was 16.7 years. Tube-related adverse events included PEG-J tube kinks (32 events), connector failures (20 events), and PEG-J tube entanglements without/with bezoars (9 events/5 events). All PEG-J tube kinks were resolved by tube manipulation with a fluoroscopic guide. In 66 of 85 events (77.6%), the PEG-J tube was placed or replaced without endoscopy.
Results date posted
| 2021 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included patients with advanced PD who underwent LCIG therapy at the NCNP from October 2016 to April 2020. Patients who stopped LCIG therapy during the initial nasojejunal tube trial were excluded.
Participant flow
This study is not applicable because it was a retrospective study.
Adverse events
The only AE that occurred during the observation period was the drop of the PEG tube into the stomach.
Outcome measures
We gathered their clinical data, including age, sex, duration of illness, Hoehn & Yahr Stage, PEG status, regular tube replacement, and tube-related AEs, from electronic medical records.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 19 | Day |
Other
Other related information
This study is a retrospective survey of patients who received LCIG therapy at the National Center Hospital, National Center of Neurology and Psychiatry (NCNP).
Management information
Registered date
| 2020 | Year | 06 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046478
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/06/11 | 01. ＜医学系指針対応：2018年10月NCNP改訂版＞研究計画書 LCIGのチューブ交換に関する研究.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
