Unique ID issued by UMIN | UMIN000021440 |
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Receipt number | R000024538 |
Scientific Title | A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis. |
Date of disclosure of the study information | 2016/03/12 |
Last modified on | 2020/03/22 18:29:07 |
A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis.
A multicenter prospective study to assess utility and safety of a metal stent
A multicenter prospective study to assess utility and safety of a metal stent with low axial force for obstructive jaundice in patients with unresectable malingant distal biliary stenosis.
A multicenter prospective study to assess utility and safety of a metal stent
Japan |
Obstructive jaundice
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To assess the clinical outcome of a new self-expandable metal stent with low axial force for drainage treatment of obstructive jaundice due to unresectable malignant distal biliary stenosis.
Safety,Efficacy
stent patency
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. patinets with unresectable malignant distal biliary stenosis with histological evidence
2. ECOG(Eastern Cooperative Oncology Group) performance status 0-3
3. Written informed consent
1. Inability to expect efficacy of biliary drainage
2. severe failure of the other organs: ASA classification of 3 or more
3. ECOG performance status 4
4. poor prognosis of 3 months or less
5. complication with hilar stenosis due to lymph node metastasis
6. post-surgical reconstruction of bile duct
80
1st name | Kentaro |
Middle name | |
Last name | Yamao |
Kinki University faculty of Medicine
Department of Gastroenterology and Hepatology
589-8511
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
072-366-0221
yamaken_volvo@yahoo.co.jp
1st name | Kentaro |
Middle name | |
Last name | Yamao |
Kinki University Faculty of Medicine
Department of Gastroenterology and Hepatology
589-8511
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
072-366-0221
yamaken_volvo@yahoo.co.jp
Kinki University Faculty of Medicine
Kinki University Faculty of Medicine
Self funding
Institute Review Board in Kidai University
377-2 Ohno-higashi, Osaka-sayama, Osaka, Japan
072-366-0221
zizen@med.kindai.ac.jp
NO
大阪医科大学病院(大阪)、ベルランド総合病院(大阪)、日本赤十字社医療センター(和歌山県)、豊中市立病院(大阪)、北野病院(大阪)、宝塚市立病院(兵庫県)、神戸大学病院(兵庫県)
2016 | Year | 03 | Month | 12 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2016 | Year | 02 | Month | 15 | Day |
2018 | Year | 05 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 07 | Month | 30 | Day |
2019 | Year | 04 | Month | 01 | Day |
Study design: Cohort study
Patients: All consective patients with inclusion criteria in February, 2016-December, 2017.
To assess utility and safety of a new self-expandable metal stent with low axial force for drainage treatment of obstructive jaundice due to unresectable malignant distal biliary stenosis.
2016 | Year | 03 | Month | 11 | Day |
2020 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024538
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