臨床研究等提出・公開システム

A Study on Intraoperative Fluorescence Imaging Using Indocyanine Green (ICG) in Laparoscopic Deroofing

ICG Fluorescence in Laparoscopic Deroofing

Otsuka Yuichiro

Toho University Omori Medical Center

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan

yotsuka@med.toho-u.ac.jp

Matsumoto Yu

Toho University Omori Medical Center

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan

+81-3-3762-4151

yuu.matsumoto@med.toho-u.ac.jp

Pending

Dec. 15, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

Patients with hepatic cystic disease require dome resection.
1) Cases diagnosed preoperatively with hepatic cysts and scheduled for dome resection.
2) Cases deemed by the responsible physician or assigned physician at the facility to have suitable general health and sufficient hepatic reserve for surgery.
3) Patients of an age capable of understanding and providing informed consent.
4) Cases where the patient has been given an explanation using the explanatory document and has provided written consent.

Exclusion Criteria:
1) Cases with a history of hypersensitivity to ICG.
2) Cases with a history of hypersensitivity to iodine-based contrast agents.
3) Cases with a history of severe hypersensitivity.
4) Cases of adults lacking sufficient judgment.

Both

Liver Cyst

Intervention study, non-comparative trial (no control group).
Presence of control group: No; Intended for use in all cases (excluding patients with a history of iodine hypersensitivity)

Liver Cyst ICG

Non-comparative study

Liver Cyst

Non-comparative study

The boundary between the cyst wall and liver parenchyma during laparoscopic cystectomy, and the biliary tract (intrahepatic bile ducts, bile duct course within the cyst wall, etc.)

Bile leakage, presence of bile duct injury.
Other information extracted from medical records includes surgical duration, blood loss, and other surgical-related items, as well as medical history.

+81-3-3762-4151

Nov. 04, 2025

Yes

Regarding personal information, a data management officer shall be appointed, and the utmost care shall be taken in handling the data. Collected data shall be processed by the data management officer into non-personally identifiable information, securely stored in a locked facility, and incinerated or destroyed once data collection is complete.

none