Unique ID issued by UMIN | UMIN000007816 |
---|---|
Receipt number | R000009212 |
Scientific Title | Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system |
Date of disclosure of the study information | 2012/05/01 |
Last modified on | 2018/08/11 06:54:22 |
Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Clinical study on sentinel lymphnode in gynecologic malignancies
Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Clinical study on sentinel lymphnode in gynecologic malignancies
Japan |
gynecologic malignancies (cervical cancer, endometrial cancer, and vulvar cancer)
Obstetrics and Gynecology |
Malignancy
NO
To determine the validity of sentinel lymph node detection system in the treatment of gynecologic malignancies
Efficacy
Confirmatory
Pragmatic
Not applicable
Histopathologic diagnosis of dissected lymph nodes, positive rate of sentinel lymph nodes, and validity of dissection range
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Maneuver |
99mTc labeled phytic acid and patent-blue dye is injected around the lesion one day before surgery and just prior to operation, respectively. Intraoperatively, colored sentinel lymph nodes (SLN) are also identified with RI-detection device. Systematic lymphadenectomy is performed to confirm tumor metastasis in all lymph nodes including SLN by histological investigation.
Not applicable |
Not applicable |
Female
cervical cancer stage Ia-IIb
vulvar cancer stage Ia-II
endometrial cancer stage Ia-II
Those who cannot be afforeded to standard therapy
150
1st name | |
Middle name | |
Last name | Masaki Mandai |
Kyoto University Graduate School of Medicine
Gynecology and Obstetrics
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
0757513269
babatsu@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Tsukasa Baba |
Kyoto University Graduate School of Medicine
Gynecology and Obstetrics
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
0757513269
babatsu@kuhp.kyoto-u.ac.jp
Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Self funding
NO
2012 | Year | 05 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 04 | Month | 23 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 04 | Month | 23 | Day |
2018 | Year | 08 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009212
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |