UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056055 |
|---|---|
| Receipt number | R000064057 |
| Scientific Title | Thoracoscopic surgery for complicated parapneumonic effusions during urokinase shortage |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/06 10:21:37 |
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Basic information
Public title
Thoracoscopic surgery for complicated parapneumonic effusions during urokinase shortage
Acronym
Thoracoscopic surgery for complicated parapneumonic effusions during urokinase shortage
Scientific Title
Thoracoscopic surgery for complicated parapneumonic effusions during urokinase shortage
Scientific Title:Acronym
Thoracoscopic surgery for complicated parapneumonic effusions during urokinase shortage
Region
| Japan |
Condition
Condition
complicated parapneumonic effusions
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urokinase has been in short supply since around February 2022 due to quality deterioration during the manufacturing process of the active pharmaceutical ingredient, and the shortage continues as of February 2024. We investigated whether patients are suffering from disadvantages due to the reduction in treatment options for parapneumonic pleural effusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment and outcome of complicated parapneumonic pleural effusion
Key secondary outcomes
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
Between January 2014 and January 2024, 125 patients who were admitted to the Department of Respiratory Medicine at our hospital due to complicated parapneumonic pleural effusion and treated with thoracic drainage were included in the study.
Key exclusion criteria
none
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
respiratory24@outlook.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
Homepage URL
respiratory24@outlook.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
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
Matsuyama Red Cross Hospital
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
Tel
0899241111
respiratory24@outlook.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
| 2024 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.matsuyama.jrc.or.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.matsuyama.jrc.or.jp/
Number of participants that the trial has enrolled
113
Results
Following the shortage in urokinase supply, the prevalence of fibrinolytic therapy decreased from 63% to 16%, whereas that of thoracoscopic surgery increased from 27% to 53%. The time to thoracoscopic surgery and surgical duration were shortened by 4 days and 33 min, respectively. No impact on outcome, length of hospital stay, or hospital costs was detected.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively analyzed data from 113 patients, who were admitted to our respiratory department with complicated parapneumonic effusion and underwent thoracic drainage between January 2014 and January 2024.In this cohort, 43% were high-risk patients (according to the RAPID score).
Participant flow
none
Adverse events
none
Outcome measures
The primary outcome was treatment and outcome of complicated parapneumonic pleural effusion, and the secondary outcome was hospitalization costs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively analyzed data from 113 patients, who were admitted to our respiratory department with complicated parapneumonic effusion and underwent thoracic drainage between January 2014 and January 2024.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064057
