Unique ID issued by UMIN | UMIN000012993 |
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Receipt number | R000015172 |
Scientific Title | Initial evaluation of a new, fourfold-flanged, single pigtail plastic stent designed for the endoscopic ultrasonography-guided hepaticoenterostomy |
Date of disclosure of the study information | 2014/01/28 |
Last modified on | 2016/02/29 00:08:15 |
Initial evaluation of a new, fourfold-flanged, single pigtail plastic stent designed for the endoscopic ultrasonography-guided hepaticoenterostomy
Evaluation of a new stent designed for the endoscopic ultrasonography-guided hepaticoenterostomy
Initial evaluation of a new, fourfold-flanged, single pigtail plastic stent designed for the endoscopic ultrasonography-guided hepaticoenterostomy
Evaluation of a new stent designed for the endoscopic ultrasonography-guided hepaticoenterostomy
Japan |
Patients in whom biliary drainage are needed. And difficult ERCP cases.
Hepato-biliary-pancreatic medicine |
Others
NO
To prospectively evaluate evaluated the feasibility of the novel stent in EUS-guided drainage of the hepaticoenterostomy.
Safety
Confirmatory
Pragmatic
Phase I,II
Successful rate of EUS-guided hepaticoenterostomy drainage.
Kinds and frequency of complications.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Endoscopic ultrasonography-guided hepaticogastrostomy
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients in whom biliary drainage are needed, obstructive jaundice and/or cholangitis.
2. Recommendation of BD stenting
3. Surgically altered anatomy
4. Failed ERC
1. Cases having difficulty in endoscopic approach
2. Cases in Performance status 4
3. Cases with sever complication in other organs
4. Cases without informed consent
5. Cases judged by principal investigator to be inadequate as subjects
30
1st name | |
Middle name | |
Last name | Takao Itoi |
Tokyo Medical University Hospital
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
03-3342-6111
itoi@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takao Itoi |
Tokyo Medical University Hospital
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
03-3342-6111
itoi@tokyo-med.ac.jp
Tokyo Medical University Hospital, Department of the 4th Internal medicine
Tokyo Medical University
Self funding
Yuri-kumiai general hospital
NO
東京医科大学病院(東京都)
2014 | Year | 01 | Month | 28 | Day |
Published
Completed
2013 | Year | 08 | Month | 30 | Day |
2013 | Year | 12 | Month | 10 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 01 | Month | 28 | Day |
2016 | Year | 02 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015172
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