Japanease

Feb. 26, 2019

Feb. 26, 2020

jRCT1051180076

Intraoperative near-infrared fluorescence imaging using indocyanine green during staging laparoscopy for detecting small metastasis in pancreatic cancer: A prospective study (NIRPC)

NIR fluorescence imaging during staging laparoscopy for detecting metastases in pancreatic cancer (NIRPC)

Fukumoto Takumi

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo

+81-78-382-6302

fukumoto@med.kobe-u.ac.jp

Shirakawa Sachiyo

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo

+81-78-382-6302

sachiyo@pearl.kobe-u.ac.jp

Oct. 15, 2018

40

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

none

- Aged 20 or over and can provide written voluntary consent to participate
- Pathologically or clinically diagnosed as pancreatic cancer
- Radiographically non-metastatic disease
- Planned for the staging laparoscopy followed by a local treatment: pancreatic resection or radiation

- Allergy to iodine
- For any reason, the investigators think that the patient should not participate

20age old over
No limit

Both

Pancreatic cancer

D007208

Indocyanine green, Near-infrared light

Indocyanine green will administer to patients intravenously before the staging laparoscopy and we will look inside the abdominal cavity with near-infrared light.

C535836

Pancreatic cancer, Staging laparoscopy

The number of detected liver metastasis

- The rate of patients with the need to change treatment as a result of the exploration with NIR imaging
- The rate of patients with allergy for ICG
- The incidence of postoperative complications

Recruiting

Kobe University Clinical Research Ethical Comittee
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo

+81-78-382-6669

cerb@med.kobe-u.ac.jp
Approval

Feb. 13, 2019

UMIN000025900
UMIN Clinical Trial Registry (UMIN-CTR)