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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040919
Receipt No. 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

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Basic information
Public title Real-time assessment of liver functional reserve in the remnant liver or transplanted graft
Acronym RTALF trial
Scientific Title Real-time assessment of liver functional reserve in the remnant liver or transplanted graft using indocyanine green pulse spectrophotometry
Scientific Title:Acronym ICG-RTALF trial
Region
Japan

Condition
Condition patients with disease requring hepatectomy or liver transplantation recipient
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Post-hepatectomy liver failure, defined by ISGLS, for patients undergoing hepatectomy.

Graft failure for transplant recipient
Key secondary outcomes

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 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
Key exclusion criteria 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.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Marubashi
Organization Fukushima medical university
Division name Department of Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code 9601295
Address 1 Hikarigaoka Fukushima
TEL 0245471254
Email s-maru@fmu.ac.jp

Public contact
Name of contact person
1st name Naoya
Middle name Sato
Last name Sato
Organization Fukushima medical univerisyt
Division name Department of Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code 960-1295
Address 1 Hikarigaoka
TEL 0245471254
Homepage URL
Email nawoya@fmu.ac.jp

Sponsor
Institute Fukushima medical university
Department of Hepato-Biliary-Pancreatic and Transplant surgery
Institute
Department

Funding Source
Organization Fukushima medical university
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 Fukushima medical univerity
Address 1 Hikarigaoka Fukushima
Tel 024-547-1111
Email rs@fmu.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

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
2016 Year 05 Month 15 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2021 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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.

Management information
Registered date
2020 Year 06 Month 28 Day
Last modified on
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046547

Research Plan
Registered date File name
2020/06/28 研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/06/28 dataICG.xlsx


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