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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034123
Receipt No. 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 2019/09/14

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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
Middle name
Last name Okamoto Yoshiaki
Organization Ashiya Munucipal Hospital
Division name Department of Pharmacy
Zip code
Address Hyogo, Ashiya, Asahigaokacho 39-1
TEL 0797-31-2156
Email okamoysh@phs.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Niki
Organization Osaka University/Ashiya Municipal Hospital
Division name Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL 06-6879-8250
Homepage URL
Email k-niki@phs.osaka-u.ac.jp

Sponsor
Institute Ashiya Municipal Hospital
Institute
Department

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
Address
Tel
Email

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
2021 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
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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