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 |
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
the study of Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Intraoperative imaging by indocyanine green (ICG) fluorescence in laparoscopic deroofing for liver cyst
Japan |
liver cyst
Hepato-biliary-pancreatic surgery |
Others
NO
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.
Efficacy
Safety and accuracy in the identification of Bile leakage or bile duct injury in laparoscopic deroofing
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Indocyanine Green 2.5mg . once immediately before surgery
20 | years-old | <= |
100 | years-old | >= |
Male and Female
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.
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".
15
1st name | Otsuka |
Middle name | |
Last name | Yichiro |
Omori Hospital, Toho University Medical Center
Department of Surgery, General and Gastroenterological surgery
1438541
6-11-1 Omori nishi, Ota-ku, Tokyo
03-3762-4151
yotsuka@med.toho-u.ac.jp
1st name | Kimura |
Middle name | |
Last name | Kazutaka |
Omori Hospital, Toho University Medical Center
Department of Surgery, General and Gastroenterological surger
1438541
6-11-1 Omori nishi, Ota-ku, Tokyo
03-3762-4151
kazutaka.kimura@med.toho-u.ac.jp
Toho University
Toho University
Other
Omori Hospital, Toho University Medical Center
6-11-1 Omori nishi, Ota-ku, Tokyo
03-3762-4151
kazutaka.kimura@med.toho-u.ac.jp
NO
2022 | Year | 03 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 12 | Month | 31 | Day |
2022 | Year | 03 | Month | 17 | Day |
2022 | Year | 03 | Month | 18 | Day |
2025 | Year | 03 | Month | 18 | Day |
2022 | Year | 03 | Month | 11 | Day |
2024 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053791