Unique ID issued by UMIN | UMIN000042019 |
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Receipt number | R000047957 |
Scientific Title | Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones |
Date of disclosure of the study information | 2021/02/01 |
Last modified on | 2023/04/10 11:23:51 |
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Japan |
Common bile duct stones
Hepato-biliary-pancreatic medicine |
Others
NO
We will examine the efficacy and safety of endoscopic stone removal using a new guide wire-guided 8-wire basket catheter for patients with common bile duct stones.
Safety,Efficacy
Complete stone removal rate for new GW-guided 8-wire basket catheter
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Use of new GW induction 8-wire basket catheter
20 | years-old | <= |
Not applicable |
Male and Female
Patients who meet the following criteria are targeted.
(1) Abdominal echo, CT, MRI, endoscopic ultrasonography (EUS), ERCP (+ IDUS can be used together) imaging test or blood test findings, clinical symptoms diagnosed as common bile duct stone, Alternatively, a suspected patient.
(2) Over 20 years old at the time of study registration.
(3) Cases in which the maximum stone diameter at the time of image diagnosis is 10 mm or less, or cases in which stones of 10 mm or less are suspected even if stones cannot be confirmed on the image.
(4) Participants have received sufficient explanation about the research content and have agreed to the document.
(1) Postoperatively reconstructed intestinal tract cases other than Billroth-I reconstruction.
(2) Cases of bile duct stenosis or cases of bile duct diameter of 30 mm or more.
(3) Cases with bleeding tendency.
(4) A patient with a history of endoscopic nipple dilatation (EPLBD).
(5) A case of severe cholangitis at Tokyo Guideline 2018. (However, it is not excluded after improvement of severe cholangitis.)
(6) A case of gallstone pancreatitis. (However, it is not excluded after improvement of pancreatitis.)
(7) Insufficient opening of the nipple or obstruction of stones and passage of the basket catheter (because there is a risk of incarceration).
(8) Pregnant or potentially pregnant cases.
(9) Other cases judged to be inappropriate as a target by the judgment of a doctor
150
1st name | Kazuya |
Middle name | |
Last name | Sugimori |
Yokohama City University Medical Center
Gastroenterology Center
2320024
4-57 Urafune, Minami-ku, Yokohama
0452615656
sugimori@yokohama-cu.ac.jp
1st name | Takashi |
Middle name | |
Last name | Kaneko |
Yokohama City University Medical Center
Gastroenterology Center
2320024
4-57 Urafune, Minami-ku, Yokohama
0452615656
taku47@yokohama-cu.ac.jp
Yokohama City University Medical Center
non
Other
Yokohama City University Public University Research Ethics Committee for Humans
3-9 Fukuura, Kanazawa-ku, Yokohama
0453707627
rinri@yokohama-cu.ac.jp
NO
2021 | Year | 02 | Month | 01 | Day |
Unpublished
Main results already published
2020 | Year | 10 | Month | 05 | Day |
2020 | Year | 12 | Month | 24 | Day |
2021 | Year | 01 | Month | 01 | Day |
2025 | Year | 12 | Month | 31 | Day |
2020 | Year | 10 | Month | 05 | Day |
2023 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047957
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