Unique ID issued by UMIN | UMIN000025584 |
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Receipt number | R000029442 |
Scientific Title | A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma |
Date of disclosure of the study information | 2017/02/01 |
Last modified on | 2023/07/16 09:43:48 |
A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma
NABIS-02 study
A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma
NABIS-02 study
Japan |
Preoperative perihilar cholangiocarcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To elucidate tolerability of Fully Covered Metallic Stent for preoperative perihilar cholangiocarcinoma patients
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Rate of cases who do not need stent exchange until surgical operation
Confirm the surgical operation safety and complication related stent and surgical operation of Fully Covered Metallic Stent for preoperative perihilar cholangiocarcinoma
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
Exchange the drainage methods from ENBD to Fully covered Metallic Stent
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Operable perihilar cholangiocarcinoma. (image diagnosis)
Patients already inserted ENBD for future remnant liver lobe(s) and waiting periods more than 2 weeks to surgical operation.
More than 10mm of bile duct length from edge of upstream stricture site to the first biliary branch
PS(ECOG) 0 or 1
Adequate oral intake
Estimated life expectancy more than 3 months
With informed concent
Fever up more than 38 degree
Severe neurologic impairment or mental disorder
With severe other organ disorder
Without another malignant disease
Pregnant or lactating women
10
1st name | Yoshiki |
Middle name | |
Last name | Hirooka |
Nagoya University
Hospital Department of Endoscopy
466-8550
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
0527442166
h-kawa@med.nagoya-u.ac.jp
1st name | HIroki |
Middle name | |
Last name | Kawashima |
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
466-8550
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
0527442166
h-kawa@med.nagoya-u.ac.jp
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Self funding
Japan
Nagoya University Hospital IRB
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
052-744-2602
ethics@med.nagoya-u.ac.jp
NO
名古屋大学医学部附属病院(愛知県)
2017 | Year | 02 | Month | 01 | Day |
Unpublished
Main results already published
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 04 | Month | 01 | Day |
2017 | Year | 03 | Month | 15 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 06 | Month | 30 | Day |
2017 | Year | 01 | Month | 09 | Day |
2023 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029442
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