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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033221
Receipt No. R000037082
Scientific Title Multicenter study of the patients with refractory ascites.
Date of disclosure of the study information 2018/08/01
Last modified on 2018/09/07

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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
Middle name
Last name Hideto Kawaratani
Organization Nara Medical University
Division name The third department of internal medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051(3415)
Email kawara@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideto Kawaratani
Organization Nara Medical University
Division name The third department of internal medicine
Zip code
Address Shijyo-cho 840, Kashihara, Nara, Japan
TEL 0744-22-3051(3415)
Homepage URL
Email kawara@naramed-u.ac.jp

Sponsor
Institute The third department of internal medicine, Nara Medical University
Institute
Department

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
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 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 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 01 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037082

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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