Unique ID issued by UMIN | UMIN000031110 |
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Receipt number | R000034361 |
Scientific Title | Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma |
Date of disclosure of the study information | 2019/01/01 |
Last modified on | 2021/02/03 23:30:03 |
Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma
Large-bore metal stent study (LBM study)
Pilot study of a large-bore, fully covered self-expandable metal stents for distal biliary obstruction caused by pancreatic carcinoma
Large-bore metal stent study (LBM study)
Japan |
Unresectable pancreatic cancer with malignant biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the patency and safety of Fully-covered, large-bore metal stent for unresectable pancreatic cancer with distal biliary obstruction.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Time to stent dysfunction
Effectiveness
1) Stent patency period
2) Survival period
3) Event free survival
4) Stent patency period after reintervention
5) Time to stent dysfunction after reintervention
6) Cost effectiveness
Safety
1) Early complications
2) Late complications
3) Technical success rate
4) Removability of the stent
5) Removability of the second stent
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
New designed large-bore, fully covered self-expandable metallic stent
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with unresectable pancreatic cancer with distal malignant biliary obstruction.
2) Patients with predictable prognosis of more than 4 months.
3) Patients with written informed consent.
4) Patients with performance status 0-3.
1) Patients with massive ascites.
2) Patients with severely impaired organ function.
3) Patients for whom endoscopic biliary drainage is difficult.
4) Patients with duodenal obstruction.
5) Patients whose antithrombotic drugs cannot be stopped.
6) Patients considered ineligible for this study.
20
1st name | Akira |
Middle name | |
Last name | Kurita |
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Department of Gastroenterology and Hepatology
530-8480
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
06-6312-8831
kuritaaki1976@gmail.com
1st name | Akira |
Middle name | |
Last name | Kurita |
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Department of Gastroenterology and Hepatology
530-8480
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
06-6312-8831
kuritaaki1976@gmail.com
Kitano Hospital, Tazuke Kofukai Medical Research Institute
None
Self funding
Kitano Hospital, Tazuke Kofukai Medical Research Institute
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
06-6312-8831
rinshou@kitano-hp.or.jp
NO
2019 | Year | 01 | Month | 01 | Day |
Unpublished
10
No longer recruiting
2017 | Year | 12 | Month | 13 | Day |
2017 | Year | 12 | Month | 13 | Day |
2018 | Year | 02 | Month | 12 | Day |
2023 | Year | 12 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 04 | Month | 01 | Day |
2024 | Year | 07 | Month | 31 | Day |
2018 | Year | 02 | Month | 01 | Day |
2021 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034361
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