UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047174 |
|---|---|
| Receipt number | R000053798 |
| Scientific Title | Identification of anatomical territory and diagnosis of liver tumors during hepatic resection by indocyanine green (ICG) fluorescence imaging |
| Date of disclosure of the study information | 2022/03/17 |
| Last modified on | 2024/09/14 10:04:57 |
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Basic information
Public title
Identification of anatomical territory and diagnosis of liver tumors during hepatic resection by indocyanine green (ICG) fluorescence imaging
Acronym
Identification of anatomical territory and diagnosis of liver tumors during hepatic resection by indocyanine green (ICG) fluorescence imaging
Scientific Title
Identification of anatomical territory and diagnosis of liver tumors during hepatic resection by indocyanine green (ICG) fluorescence imaging
Scientific Title:Acronym
Identification of anatomical territory and diagnosis of liver tumors during hepatic resection by indocyanine green (ICG) fluorescence imaging
Region
| Japan |
Condition
Condition
Primary liver cancer, metastatic liver cancer, benign liver disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is used to identify the hepatic anatomical territory, to diagnose hepatic malignancyduring open or laparoscopic surgery,using ICG fluorescent method.Positive staining (PS) and negative staining (NS) methods are used to identify the exact area in anatomical domain of the liver. This diagnostic method is also expected to be a diagnostic tool in cancer surgery, and its safety and efficacy will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy and safety in the identification of anatomical territory of section or segment during the liver resection
Accuracy and safety in the identification of liver tumors during the liver resection
Key secondary outcomes
Operative duration
Blood loss
Postoperative hospital stay
Postoperative morbidity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
ICG 25 mg/vial dissolved in 10 ml of the accompanying water for injection as a base (or further diluted with an appropriate amount of saline) is injected intravenously or topically into the intrahepatic portal vein.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients whose preoperative diagnosis is primary liver cancer, metastatic liver cancer, or benign hepatic disease to be treated by hepatic resection.
2) Patients whose general condition and hepatic reserve are judged by the responsible or collaborating physicians to be sufficient to tolerate the operation.
3) Patients must be at least 20 years of age at the time consent is obtained.
4) The patient must have been given a written explanation of the procedure and his/her written consent must have been obtained.
Key exclusion criteria
1) Patients with a history of allergy to ICG.
(2) Patients with a history of allergy to iodine-based contrast media.
3) Patients with a serious allergy history.
(4) Adults with impaired judgment.
(5) Adults who are unconscious.
(6) Patients who need to be considered for the disclosure of the disease.
(7) Other cases that the investigator or sub-investigator deems inappropriate to participate in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Otsuka |
| Middle name | |
| Last name | Yichiro |
Organization
Omori Hospital, Toho University Medical Center
Division name
Department of Surgery, General and Gastroenterological surgery
Zip code
1438541
Address
6-11-1 Omori nishi, Ota-ku, Tokyo
TEL
03-3762-4151
yotsuka@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Otsuka |
| Middle name | |
| Last name | Yichiro |
Organization
Omori Hospital, Toho University Medical Center
Division name
Department of Surgery, General and Gastroenterological surgery
Zip code
1438541
Address
6-11-1 Omori nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
yotsuka@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omori Hospital, Toho University Medical Center
Address
6-11-1 Omori nishi, Ota-ku, Tokyo
Tel
0357636534
omori.rinri@ext.toho-u.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
| 2022 | Year | 03 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ongoing
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053798
