UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040919 |
|---|---|
| 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 | 2025/07/07 15:48:43 |
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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
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
nawoya@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical university
Department of Hepato-Biliary-Pancreatic and Transplant surgery
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/34392399/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34392399/
Number of participants that the trial has enrolled
31
Results
Results: Of the operations performed, 87.1% were major hepatectomy. PHLF Grade B/C was observed in eight patients (25.8%) with no mortality. The concordance indices of intraoperative ICG-PDR and ICG-PDR for predicting PHLF were 0.834 (95% CI, 0.69-0.98) and 0.834 (95% CI, 0.69-0.98), respectively.
Conclusions: Intraoperative ICG clearance in the remnant liver was a promising predictor for PHLF in patients undergoing anatomical hepatectomy, especially in patients with BD.
Results date posted
| 2025 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-one patients were enrolled in this study between June 2016 and September 2019. The entire population had a median age of 69 years and the proportion of males was 61.3%. In 17 patients with jaundice secondary to neoplasms, preoperative biliary drainage was performed for diagnosis and to normalize liver function for surgery. The median value of total bilirubin levels prior to BD was 13.2 mg/dl. The waiting period from the primary biliary drainage to surgery was almost four weeks, and 41.1 % of the patients developed cholangitis after drainage, resulting in biliary stent replacement.
Participant flow
no recruitment
Adverse events
none
Outcome measures
The univariate analysis showed that lower prothrombin time (P = 0.0062), lower FLR/TLV (P = 0.0068) and six ICG associated variables [preoperative ICG-R15 (P = 0.04), preoperative ICG-PDR values (P = 0.03), ICG-remK (P = 0.0062), intraoperative ICG-R15 (P = 0.0055), and intraoperative ICG-PDR (P = 0.0055)] were potentially correlated with PHLF. As shown in Figure 2, patients with PHLF had significantly higher intraoperative ICG-R15 and lower intraoperative ICG-PDR than those without PHLF. The individual median value of intraoperative ICG clearance in patients with or without PHLF was 5.0 %/min (iqr, 7.8-12.3) or 15.3 %/min (iqr, 12.6-16.7) for ICG-PDR, and 20.6 % (iqr, 16.3-31.1) or 10.1% (iqr, 8.2-15.1) for ICG-R15, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046547
