Unique ID issued by UMIN | UMIN000053929 |
---|---|
Receipt number | R000061556 |
Scientific Title | Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system |
Date of disclosure of the study information | 2024/04/01 |
Last modified on | 2024/03/21 15:00:52 |
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Prospective evaluation study of one-step technique during EUS-guided hepaticogastrostomy using a partially covered self-expandable metal stent with fine gauge stent delivery system
Japan |
Biliary obstruction
Hepato-biliary-pancreatic medicine | Adult |
Malignancy
NO
The aim of this study is to evaluate technical feasibility and safety of one-step deployment during EUS-HGS using novel stent
Safety,Efficacy
Technical success rate
Final technical success rate, clinical success rate, adverse events, procedure time, additional rate of tract dilation, rate of bile leakage
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
EUS-HGS is performed using a partially covered self-expandable metal stent with fine gauge stent delivery system
18 | years-old | <= |
Not applicable |
Male and Female
1. Biliary obstruction cases
2. Age is over 18 yo
3. Obtaining informed consent
1. total gastorectomy
2. ascites
3. pregnancy, risk of bleeding
4. denied to participate this study
5. Inadequate reasons which are considered by doctors
25
1st name | Takeshi |
Middle name | |
Last name | Ogura |
Osaka Medical and Pharmaceutical University Hospital
Endoscopy Center
569-8686
2-7 Daigakuchou, Takatsukishi, Osaka
072-683-1221
oguratakeshi0411@yahoo.co.jp
1st name | Nobu |
Middle name | |
Last name | Nishioka |
Osaka Medical and Pharmaceutical University
2nd Department of Internal Medicine
569-8686
2-7 Daigakuchou, Takatsukishi, Osaka
072-683-1221
yumegiwa8916@yahoo.co.jp
Osaka Medical and Pharmaceutical University
Osaka Medical and Pharmaceutical University
Self funding
Research Ethics Committee of Osaka Medical and Pharmaceutical University
2-7 Daigakuchou, Takatsukishi, Osaka
072-683-1221
rinri@ompu.ac.jp
NO
2024 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2024 | Year | 01 | Month | 04 | Day |
2024 | Year | 04 | Month | 01 | Day |
2027 | Year | 02 | Month | 01 | Day |
2024 | Year | 03 | Month | 21 | Day |
2024 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061556