Unique ID issued by UMIN | UMIN000040919 |
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Receipt number | R000046547 |
Scientific Title | Real-time assessment of liver functional reserve in the remnant liver or transplanted graft using indocyanine green pulse spectrophotometry |
Date of disclosure of the study information | 2020/07/01 |
Last modified on | 2020/06/28 00:06:06 |
Real-time assessment of liver functional reserve in the remnant liver or transplanted graft
RTALF trial
Real-time assessment of liver functional reserve in the remnant liver or transplanted graft using indocyanine green pulse spectrophotometry
ICG-RTALF trial
Japan |
patients with disease requring hepatectomy or liver transplantation recipient
Hepato-biliary-pancreatic surgery |
Others
NO
Regarding to patients undergoing hepatectomy,aim of the study is to investigate whether the intraoperative ICG clearance value in the future remnant liver could predict post-hepatectomy liver failure. Regarding to transplant recipients, aim of the study is to investigate whether ICG clearance measured during postoperative periods could predict liver graft outcome.
Efficacy
Not applicable
Post-hepatectomy liver failure, defined by ISGLS, for patients undergoing hepatectomy.
Graft failure for transplant recipient
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)patients with hepatectomy(h) performance status, according to the eastern cooperative oncology group criteria of grade 0 or 1
transplant recipients (t) ecog grade 0-3
2) h: child-pugh a or b
t: child-pugh a-c
3) laboratory data (within 14 days before registration)
1.white blood cell >= 2000/ul
2.neutrophil >= 1000/ul
3.hemoglobin >= 9.0g/dl
4.platelet >= 70000/ul
5.total bilirubin >= 2.0mg/dl
6.ast or alt <=150iu/l
7.serum creatine <=1.2mg/dl
1)patients with allergy to icg
2)patients who underwent hepatectomy with resection of other organs
3) significant medical comorbidity precluding consideration for hepatic surgery.
150
1st name | Shigeru |
Middle name | |
Last name | Marubashi |
Fukushima medical university
Department of Hepato-Biliary-Pancreatic and Transplant Surgery
9601295
1 Hikarigaoka Fukushima
0245471254
s-maru@fmu.ac.jp
1st name | Naoya |
Middle name | Sato |
Last name | Sato |
Fukushima medical univerisyt
Department of Hepato-Biliary-Pancreatic and Transplant Surgery
960-1295
1 Hikarigaoka
0245471254
nawoya@fmu.ac.jp
Fukushima medical university
Department of Hepato-Biliary-Pancreatic and Transplant surgery
Fukushima medical university
Self funding
Fukushima medical univerity
1 Hikarigaoka Fukushima
024-547-1111
rs@fmu.ac.jp
NO
2020 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 05 | Month | 15 | Day |
2016 | Year | 06 | Month | 01 | Day |
2021 | Year | 05 | Month | 30 | Day |
We have planned to perform interim analysis to determine safty and efficacy of ICG monitoring when the number of the registerd patients in greater than 30.
2020 | Year | 06 | Month | 28 | Day |
2020 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046547
Research Plan | |
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Registered date | File name |
2020/06/28 | 研究計画書.doc |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2020/06/28 | dataICG.xlsx |