UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042019 |
|---|---|
| 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 |
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Basic information
Public title
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Acronym
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
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
Scientific Title:Acronym
Single-group Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones
Region
| Japan |
Condition
Condition
Common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete stone removal rate for new GW-guided 8-wire basket catheter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of new GW induction 8-wire basket catheter
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
(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
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Sugimori |
Organization
Yokohama City University Medical Center
Division name
Gastroenterology Center
Zip code
2320024
Address
4-57 Urafune, Minami-ku, Yokohama
TEL
0452615656
sugimori@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kaneko |
Organization
Yokohama City University Medical Center
Division name
Gastroenterology Center
Zip code
2320024
Address
4-57 Urafune, Minami-ku, Yokohama
TEL
0452615656
Homepage URL
taku47@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Public University Research Ethics Committee for Humans
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0453707627
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
