UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034123 |
|---|---|
| Receipt number | R000038900 |
| Scientific Title | The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patients |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2021/03/16 12:18:38 |
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Basic information
Public title
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patients
Acronym
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patients
Scientific Title
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patients
Scientific Title:Acronym
The study on the efficacy of intraperitoneal administration of triamcinolone acetonide to cancerous ascites in end-of-life patients
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy of triamcinolone acetonide intraperitoneal administration to cancerous ascites in end-of-life patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration of ascites removal
Key secondary outcomes
Variations of symptoms before and after removal of ascites
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are evaluated their symptoms using ESAS-J and STAS-J at the time of ascites removal (1st course: day 0). They are evaluated their symptoms again using ESAS-J and STAS-J 3 days after ascites removal (1st course: day 3). After that, it is necessary to remove the ascites once more due to the storage of the ascites, and in addition there is a desire from the patient, ascites is removed, (2 nd course: day 0), after removing ascites, triamcinolone acetonide is administered at 400 mg / 10 vials / body. Also, patients are evaluated their symptoms using ESAS-J and STAS-J (2nd course: day 0). patients are evaluated thier symptoms again using ESAS-J and STAS-J 3 days after ascites removal (2nd course: day 3).
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
1.Cancer patients in hospital.
2.Medical adaptation for ascites removal.
3.There is hope of removing ascites from the patient.
4.Triamcinolone acetonide intraperitoneal administration not yet experienced.
5.Consent can be acquired in writing or verbal.
6.Cognitive function is enough to respond to survey forms.
Key exclusion criteria
Patients that do not satisfy the above selection criteria.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Okamoto |
Organization
Ashiya Munucipal Hospital
Division name
Department of Pharmacy
Zip code
659-0012
Address
Hyogo, Ashiya, Asahigaokacho 39-1
TEL
0797-31-2156
okamoysh@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Niki |
| Middle name | |
| Last name | Kazuyuki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
659-0012
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Ashiya Municipal 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
Ashiya Municipal Hospital Ethical Review Boards
Address
Hyogo, Ashiya, Asahigaokacho 39-1
Tel
0797-31-2156
k-niki@phs.osaka-u.ac.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
| 2018 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038900
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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