Unique ID issued by UMIN | UMIN000009736 |
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Receipt number | R000010656 |
Scientific Title | A prospective multicenter study of EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction |
Date of disclosure of the study information | 2013/01/09 |
Last modified on | 2016/07/09 10:55:48 |
A prospective multicenter study of EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
A prospective multicenter study of EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
EUS-guided choledochoduodenostomy for unresectable malignant biliary obstruction
Japan |
Patients with unresectable malignant distal biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate safety and efficacy of EUS-guided choledochoduodenostomy as a first line treatment for unresectable malignant distal biliary obstruction
Safety,Efficacy
Exploratory
Techinical success
complications, stent patency
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
EUS-guided choledochoduodenostomy
20 | years-old | <= |
Not applicable |
Male and Female
1. unresectable malignant distal biliary obstruction without prior drainage
2. Age >= 20 y.o.
3. Serum T.Bil >=2.0 mg/dL
4. ECOG Performance Status 0-2
5. Informed consent
1. Ascites
2. Prior gastric surgery
3. Biliary obstruction within 2 cm from hepatic hilum
4. Failure to detect CBD on EUS
5. Patients on anticoagulant or antiplatelet medications
6. Coagulopathy (Platlet < 50,000 or PT-INR >=2)
7. Severe comorbidity
8. Failed informed consent
9. Patients considered to be inadequate for clinical trials
30
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
The University of Tokyo
Department of Gastroenterology, Graduate School of Medicine
7-3-1, Hongo, Bunkyo-ku Tokyo
03-3815-5411
isayama-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Yousuke Nakai |
The University of Tokyo
Department of Gastroenterology, Graduate School of Medicine
7-3-1 Hongo Bunkyoku Tokyo
03-3815-5411
ynakai-tky@umin.ac.jp
The University of Tokyo, Department of Gastroenterology
None
Self funding
NO
2013 | Year | 01 | Month | 09 | Day |
Partially published
Completed
2012 | Year | 10 | Month | 25 | Day |
2013 | Year | 01 | Month | 09 | Day |
2013 | Year | 01 | Month | 09 | Day |
2016 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010656
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