UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Title of the study (Brief title)	The optimal ultra filtration method in CART
Region	Japan

Condition
Condition	Patients with refractory cancerous ascites
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the optimal ultrafiltration method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The time to reach the set pressure (TMP500mmHg)
Key secondary outcomes	1. The serial change of transmembrane pressure and ascites weight 2. Analysis of the original ascites and the filtered ascites 3. Analysis of the filter

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	Device,equipment
Interventions/Control_1	concentrated ascites reinfusion therapy
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. The patients with refractory cancerous as cites who are judged as the indication of CART 2. The first CART for the patient 3. The patients who can recognize the study and express the agreement by the document.
Key exclusion criteria	1. Patients with ascites contaminated by endotoxin 2. Severe immunocompromized patients 3. Patients who have peritoneo-venous shunt 4. Patients who have transjugular intrahepatic portosystemic shunt 5. Infection; Syphilis HBs antigen HBc antibody HCV HIV01,2 HTLV1 6. Patients who are judged as the inappropriate for this study by the doctor.
Target sample size	9

Research contact person
Name of lead principal investigator	Midori Hasegawa
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Address	1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL	0562-93-9245
Email	mhase@fujita-hu.ac.jp

Public contact
Name of contact person	Midori Hasegawa
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Address	1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL	0562-93-9245
Homepage URL
Email	mhase@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 12 Day
Anticipated trial start date	2017 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029223