UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047155 |
|---|---|
| Receipt number | R000053791 |
| Scientific Title | the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst |
| Date of disclosure of the study information | 2022/03/17 |
| Last modified on | 2024/09/14 10:07:58 |
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Basic information
Public title
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Acronym
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Scientific Title
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Scientific Title:Acronym
Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Region
| Japan |
Condition
Condition
liver cyst
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, it is performed during endoscopic surgery using the ICG fluorescence method, and the purpose is to clarify the identification of cyst wall and liver parenchyma boundary and biliary tract (intrahepatic bile duct, bile duct run in cyst wall) at the time of deroofing by visualizing blood vessels and organs in the living body, and to reduce complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and accuracy in the identification of Bile leakage or bile duct injury in laparoscopic deroofing
Key secondary outcomes
Evaluation of the boundary between cyst wall and liver parenchyma and biliary tract in laparoscopic deroofing. In addition to other items related to surgery such as operation time and blood loss, information extracted from medical records such as medical history
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
| Other |
Interventions/Control_1
Indocyanine Green 2.5mg . once immediately before surgery
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) Preoperative diagnosis is diagnosed as a hepatic cyst and a case of deroofing performed.
2) Cases judged by a facility liability doctor or a allotment doctor to have an intraoperative general condition and liver reserve ability
3) The age at the time of obtaining consent must be 20 years of age or older.
4) The applicant must be explained using explanatory documents and have obtained written consent from the person in question.
Key exclusion criteria
1) A case with a history of hypersensitivity to ICG.
2) If you have a history of hypersensitivity in iodine contrast agents.
3) A case with a history of severe hypersensitivity.
4) Adult and cases that are not sufficiently judgmental.
5) Adult and unconscious cases.
6) When it is necessary to consider the disease name
7) If the examiner or assigned physician deems it inappropriate to participate in this study.
8) We do not target those who study "socially vulnerable people".
Target sample size
15
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 | Kimura |
| Middle name | |
| Last name | Kazutaka |
Organization
Omori Hospital, Toho University Medical Center
Division name
Department of Surgery, General and Gastroenterological surger
Zip code
1438541
Address
6-11-1 Omori nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
kazutaka.kimura@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
03-3762-4151
kazutaka.kimura@med.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 | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | 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=R000053791
