UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033221 |
|---|---|
| Receipt number | R000037082 |
| Scientific Title | Multicenter study of the patients with refractory ascites. |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2023/03/15 01:42:59 |
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Basic information
Public title
Multicenter study of the patients with refractory ascites.
Acronym
Multicenter study of the patients with refractory ascites.
Scientific Title
Multicenter study of the patients with refractory ascites.
Scientific Title:Acronym
Multicenter study of the patients with refractory ascites.
Region
| Japan |
Condition
Condition
Liver cirrhosis with refractory ascites.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of paracentetis and CART.
To investigate the effect of paracentesis and Cell-free and Concentrated Ascites Reinfusion Therapy (CART) for the patients with refractory ascites. And to investigate the effect for liver function and kidney function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of times of paracentesis and CART, and the total puncture drainage volume.
Key secondary outcomes
Changes of QOL by questionnaire. Body weight change (comparison between registration date and each measurement date). Changes in liver function and renal function.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients over 20 years old
2)Patients who can walk by themselves
3)Patients who can describe themselves on a questionnaire form
4)Patients obtained written informed consent
5)Life expectancy of at least 12 weeks
6)Patients taking diuretics with furosemide 80 mg or less and / or spironolactone 100 mg or less
7) Adequate organ function
a) Hb>= 8.0g/dL
b) neutrophil: >= 1,500/mm3
c) Platelet: >= 30,000/mm3
d) Total bilirubin:< 4.0 mg/dL
e) ALT and AST: <= within 6 folds of normal limit
f) Serum creatine: <= 2.0 mg/dL
g) Serum natrium: >= 120mEq/L
Key exclusion criteria
1) Inadequate cardiac organ function
a) Patients with congestive heart failure above NYHA class3
b) Patients with severe hypertension
2) Patients with severe and active infectious disease (exclude HBV,HCV hepatitis)
3) Patients with or had HIV
4) Patients taking dialysis
5) Patients with portal tumor thrombosis (Vp3 or Vp4)
6) Patients with hepatic encephalopathy
7) Patients with crucial digestive bleedings within 4 weeks
8) Patients had the following treatment
a) Systemic chemotherapy
b) Being treated with invasive surgical therapy within 4 weeks
9) Patients with oral intake difficulty
10)Patients with severe digestive diseases
11)Patients taking a tablet which would affect this clinical study
12)Pregnant woman, lactating woman, or a woman suspected of pregnancy
13)Patients with severe allergic reaction to this study
14)Patients with drug abuse or psychological disorders
15) Patients concluded to be inappropriate to participate in this study by their physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Kawaratani |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051(3415)
kawara@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Kawaratani |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051(3415)
Homepage URL
kawara@naramed-u.ac.jp
Sponsor or person
Institute
The third department of internal medicine, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Nara Medical University
Address
Shijyo-cho 840, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-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
旭川赤十字病院消化器内科 （北海道）
札幌厚生病院消化器内科（肝臓内科）（北海道）
新潟大学消化器内科 （新潟県）
東京大学消化器内科 （東京都）
東京慈恵会医科大学消化器・肝臓内科 （東京都）
東京女子医科大学消化器内科 （東京都）
日本医科大学消化器・肝臓内科 （東京都）
武蔵野赤十字病院消化器科 （東京都）
北里大学消化器内科 （神奈川県）
横浜市立大学肝胆膵消化病学 （神奈川県）
岐阜大学第一内科 （岐阜県）
岐阜県総合医療センター肝臓内科 （岐阜県）
三重大学消化器・肝臓内科 （三重県）
奈良県立医科大学 内科学第三講座 （奈良県）
倉敷中央病院消化器内科 （岡山県）
広島大学消化器・代謝内科 （広島県）
山口大学消化器内科学 （山口県）
熊本大学消化器内科学分野 （熊本県）
鹿児島厚生連病院内科 （鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/hepr.13860
Number of participants that the trial has enrolled
50
Results
CART and LVP have comparable therapeutic efficacy for RA in patients with cirrhosis.
Results date posted
| 2023 | Year | 03 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 25 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037082
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