Unique ID issued by UMIN | UMIN000034036 |
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Receipt number | R000038800 |
Scientific Title | Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction |
Date of disclosure of the study information | 2018/09/10 |
Last modified on | 2019/09/06 09:07:33 |
Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
RCT of IS and MS-SBS for MHBO
Randomized control trial of inside stenting using plastic stent and side by side stenting using 6mm full-covered self expandable metallic stent for endoscopic bilateral biliary drainage to malignant hilar biliary obstruction
RCT of IS and MS-SBS for MHBO
Japan |
malignant hilar biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To compare the technical success, time to recurrent biliary obstruction, or re-intervention after recurrent biliary obstruction between inside stenting using plastic stent and side by side stenting using full-covered self expandable metallic stent
Efficacy
Time to Recurrent Biliary Obstruction
technical success rate, procedure time, functional success rate, adverse event, time of possible biliary drainage including re-intervention, survival time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Maneuver |
side by side stenting using 6mm full-covered self expandable metallic stent
inside stenting using plastic stent
20 | years-old | <= |
Not applicable |
Male and Female
1. Untreated unresectable malignant hilar biliary obstruction
2. Type 2/3/4 in Bismuth classification
3. More than 3mg/dl of serum bilirubin
4. More than 20 years old
5. More than 30 days of expected survival period
6. Written informed consent obtained
1. Patients with surgical altered anatomy or post-hepatectomy
2. Endoscopic approach to the biliary system is impossible
3. Prior biliary drainage (transient naso-biliary drainage can be included)
4. biliary obstruction to 3rd branch of bilateral bile duct
5. Pregnant women or those suspected of pregnancy
6. Patients considered ineligible by attending physicians
60
1st name | Toshifumi |
Middle name | |
Last name | Kin |
Teine-Keijinkai Hospital
Center for Gastroenterology
006-8555
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
011-681-8111
kin_toshifumi@yahoo.co.jp
1st name | Toshifumi |
Middle name | |
Last name | Kin |
Teine-Keijinkai Hospital
Center for Gastroenterology
006-8555
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
011-681-8111
kin_toshifumi@yahoo.co.jp
Center for Gastroenterology, Teine-Keijinkai Hospital
None
Self funding
Teine-Keijinkai Hospital
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
011-681-8111
teine@keijinkai.or.jp
NO
2018 | Year | 09 | Month | 10 | Day |
Unpublished
Open public recruiting
2018 | Year | 08 | Month | 22 | Day |
2018 | Year | 09 | Month | 10 | Day |
2018 | Year | 09 | Month | 05 | Day |
2019 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038800
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