UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043998 |
|---|---|
| Receipt number | R000049517 |
| Scientific Title | Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2026/04/03 13:45:50 |
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Basic information
Public title
Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture
Acronym
Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture
Scientific Title
Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture
Scientific Title:Acronym
Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture
Region
| Japan |
Condition
Condition
Distal malignant biliary stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the completion rate of the procedure when using one 0.025 inch guidewire, and found the usefulness of one 0.025 inch guidewire when treating distal malignant biliary stricture without prior endoscopic treatment. The purpose is to clarify.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
0.025inch guidewire Procedure completion rate with one
Key secondary outcomes
Incidence of complications, treatment time, incidence of product defects, replacement of surgeons
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 undergoing endoscopic bile duct stent placement under 0.025 inch guidewire for distal malignant biliary stricture without prior endoscopic treatment
Key exclusion criteria
Patients with a history of endoscopic treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yoshida |
Organization
Kawasaki Medical School
Division name
Biliary and pancreatic intervention studies
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
tansuiiv@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yoshida |
Organization
Kawasaki Medical School
Division name
Biliary and pancreatic intervention studies
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
Homepage URL
tansuiiv@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School / Hospital Ethics Committee
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
Tel
086-464-1076
tansuiiv@med.kawasaki-m.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
川崎医科大学附属病院（岡山県）、倉敷中央病院(岡山県）、岡山済生会病院(岡山県）、岡山赤十字病院（岡山県）、岡山大学病院（岡山県）、岡山ろうさい病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
https://rinri-system.kawasaki-m.ac.jp/esct/Apply/show.aspx?TYPE=1&ID=2217
Publication of results
Unpublished
Result
URL related to results and publications
https://rinri-system.kawasaki-m.ac.jp/esct/Apply/show.aspx?TYPE=4&ID=3651
Number of participants that the trial has enrolled
111
Results
The 0.025-inch guide weld (GW) can be used without problems in the treatment of distal malignant biliary strictures and appears to be a first-line GW. This study demonstrated the usefulness of using a single 0.025-inch GW in the treatment of distal malignant biliary strictures in patients without a history of endoscopic treatment.
Results date posted
| 2026 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Distal malignant biliary stricture without a history of endoscopic treatment
Participant flow
Cases of patients aged 20 years or older with distal malignant biliary stricture who have no prior history of endoscopic treatment and who undergo endoscopic biliary stent placement under a 0.025-inch guidewire.
Adverse events
none
Outcome measures
0.025inch GW Success rate of completing the procedure with one instrument
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Endoscopic retrograde pancreatobiliary angiography (ERCP) was performed for patients with distal malignant biliary stricture such as pancreatic head cancer, distal bile duct cancer, and papillary cancer with obstructive jaundice, and a bile duct stent was placed. It is necessary to secure a bile outflow route. Most of the guidewires (hereinafter referred to as GW) used during ERCP were 0.035 inch, and 0.025 inch GW was limited to cases with strong stenosis. However, in recent years, the development of 0.025 inch guidewire (GW) has progressed, and the rotation and resistance are comparable to 0.035 inch, and it is easy to pass through the stenosis site and replace the treatment tool, so 0.025 inch GW is used. The number of facilities that make it the first choice has increased. If the procedure can be completed with one 0.025 inch GW, it will be beneficial in terms of medical costs. The purpose of this study is to clarify the usefulness of a single 0.025 inch GW during treatment for distal malignant biliary stricture without prior endoscopic treatment.
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049517
