Unique ID issued by UMIN | UMIN000019847 |
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Receipt number | R000019301 |
Scientific Title | Inspection of the usefulness of the Cell-free and concentrated Ascites Reinfusion Therapy (CART) by the cryopreservation ascites. |
Date of disclosure of the study information | 2015/11/18 |
Last modified on | 2018/05/21 09:41:16 |
Inspection of the usefulness of the Cell-free and concentrated Ascites Reinfusion Therapy (CART) by the cryopreservation ascites.
Non randomized controlled trial by the cryopreservation ascites.
Inspection of the usefulness of the Cell-free and concentrated Ascites Reinfusion Therapy (CART) by the cryopreservation ascites.
Non randomized controlled trial by the cryopreservation ascites.
Japan |
Ovarian cander, Tubal carcinoma, Cervical cancer, Endometrial cancer, Primary peritoneal cancer, Liver cancer, Liver cirrhosis, Lung cancer, Gastric cancer, Colon cancer, Rectal cancer
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Chest surgery | Obstetrics and Gynecology |
Malignancy
NO
To compare the efficacy and safety of CART in the cryopreservation ascites group and the control group.
Safety,Efficacy
Confirmatory
Not applicable
Equivalency of the clinical manifestations improvement effect in the cryopreservation ascites group and the control group
Inspection of the side effect reduction effect in the preservation cryopreservation ascites group.
In the preservation cryopreservation ascites group,
1. Change of various ascites components (pH, general biochemistry, cytokine) before and after the preservation.
In the both groups,
1.Correlation of quantity of cytokine in the ascites and fever caused in the reinfusion.
2. Confirmation of safety by the examination for endotoxin.
3. Change of the blood test level before and after the treatment.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Device,equipment |
Allocate the case that the ascites are submitted to our division before 14:00 on the non-preservation ascites group.
The ascites in that group are not performed safekeeping and CART is carried out on the same day.
Allocate the case that the ascites are submitted to our division after 14:00 on the cryopreservation ascites group.
The ascites in that group are performed safekeeping (up to 24 hours) of at 4 degrees Celsius until the next day, and CART is carried out on the next day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Age over20-years old.
2. Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.
1. The patient who is higher than Serum bilirubin level 5mg/dL.
2. The patient that an infectious disease is strongly doubted by fever, abdominal symptom or high CRP level.
3. The patient with less than 1,000mL of gathered ascites (or pleural fluids).
4. The patient that hemolysis of the ascites is observed.
5. Other patients judged to be ineligible by the attending investigators.
50
1st name | |
Middle name | |
Last name | Hitoshi Kanno |
Tokyo Women's Medical University
Division of Transfusion Medicine and Cell Processing
8-1, Kawatda-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
+81-3-3353-8111
kanno.hitoshi@twmu.ac.jp
1st name | |
Middle name | |
Last name | Taiju Utugisawa |
Tokyo Women's Medical University
Department of Transfusion Medicine and Cell Processing
8-1, Kawatda-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
+81-3-3353-8111
utsugisawa.taiju@twmu.ac.jp
Department of Transfusion Medicine and Cell Processing, Tokyo Women's Medical University
Asahi Kasei Medical co., LTD
Profit organization
NO
2015 | Year | 11 | Month | 18 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 03 | Day |
2014 | Year | 04 | Month | 01 | Day |
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 06 | Month | 23 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 11 | Month | 18 | Day |
2018 | Year | 05 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019301
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