Unique ID issued by UMIN | UMIN000042199 |
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Receipt number | R000046751 |
Scientific Title | Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study |
Date of disclosure of the study information | 2020/11/01 |
Last modified on | 2022/04/23 10:27:19 |
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Intraoperative Identification of Lymphatic Flow and Evaluation of Lymph Node Metastasis Using Indocyanine Green Fluorescence Imaging for Esophageal Cancer: An Exploratory Clinical Study
Japan |
Patients with esophageal cancer who assigned to curative surgical treatment
Gastrointestinal surgery |
Malignancy
NO
To reveal the effect of lymphatic flow identification using indocyanine-green fluorescence imaging(IGFI) on predicting of the extent of lymph node metastasis in esophageal cancer patients
Safety
Sensitivity, positive likelihood ratio, negative likelihood ratio, and their confidence interval when ICG staining is used as an index evaluation and Metastasis is used as a reference standard for all dissected lymph node stations.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
We perform endoscopic submucosal injection of ICG around the primary lesion using a four-quadrant injection pattern with a 23-gauge endoscopic injection sclerotherapy needle.
20 | years-old | <= |
90 | years-old | > |
Male and Female
Esophageal cancer patients who assigned to curative surgical resection
1) 20yrs and older
2) PS(ECOG Performance status) 0 or 1
3) favorable major organ function
1) past history of ICG or Iodine hypersensitivity
2) pregnant patient
3) breast feeding patient
70
1st name | Koichi |
Middle name | |
Last name | Yagi |
Tokyo University Hospital
Department of Gastrointestinal Surgery
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
yagik-tky@umin.ac.jp
1st name | Shinichiro |
Middle name | |
Last name | Shiomi |
Tokyo University Hospital
Department of Gastrointestinal Surgery
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
sshiomi-tky@umin.ac.jp
Tokyo University Hospital, Department of Gastrointestinal Surgery
Tokyo University Hospital
Self funding
Research Ethics Office, Graduate School of Medicine, The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2020 | Year | 11 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 10 | Month | 16 | Day |
2020 | Year | 10 | Month | 15 | Day |
2020 | Year | 11 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 10 | Month | 21 | Day |
2022 | Year | 04 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046751
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