Laparoscopic ICG fluorescence imaging surgery.

JRCT ID: jRCTs041180006

Registered date:09/10/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: patients who underwent surgery
• Date of first enrollment: 29/08/2016
• Target sample size: 300
• Study type: Interventional
• Intervention(s): The subject of this study is almost all laparoscopic surgeries. After the administration of ICG intraoperatively, detection of arteries, veins, bile ducts, lymphatics, thoracic ducts, ureter, or sentinel nodes are performed under ICG fluorescence image-navigation using an image-enhanced laparoscopy. The estimation of blood supply, localization of the tumor, and detection of bile leakage are also performed. After the observation, the standard surgical approach is conducted.

Outcome(s)

• Primary Outcome: The detection rate of the target. Or, the occurrence rate of the anastomotic leakage or necrosis of the graft.
• Secondary Outcome: The occurrence of the adverse effect of ICG, such as the allergic reaction for ICG, incidences during the injection of ICG, or postoperative complications related to ICG.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Cases requiring surgery.
2) 20 years old and more.
3) Suitable for surgery under general anesthesia.
4) Having a potential demand for a detection of vessels arteries, bile ducts, or lymphatics under the fatty layer.

Exclude criteria

1) Having allergy for ICG.
2) Having allergy for iodic contrast medium.
3) Having allergy for various drugs.
4) Having psychological or neurological disease.
5) Difficult to draw an informed consent.

Related Information

• Primary Sponsor: Takamura Hiroyuki
• Source(s) of Monetary Support: kanazawa Medical University General and Digestive Surgery
• Secondary ID(s): UMIN000023828