UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062238 |
|---|---|
| Receipt number | R000071220 |
| Scientific Title | Evaluation of the Efficacy of Endoscopic Laser Treatment for Benign Biliary Strictures |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/14 22:47:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of endoscopic laser treatment for benign biliary strictures
Acronym
A study of endoscopic laser treatment for benign biliary strictures
Scientific Title
Evaluation of the Efficacy of Endoscopic Laser Treatment for Benign Biliary Strictures
Scientific Title:Acronym
Evaluation of Endoscopic Laser Treatment for Benign Biliary Strictures
Region
| Japan |
Condition
Condition
Benign Biliary Strictures
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic laser treatment for benign biliary strictures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of benign biliary strictures (defined as successful passage of the peroral cholangioscope through the stricture)
Key secondary outcomes
Incidence of clinical events, Time to event, Adverse events
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with benign biliary stricture by CT, MRI, or ERCP.
Patients whose stricture has not improved despite at least one conventional treatment, such as endoscopic balloon dilation or endoscopic biliary stent placement, and who require further treatment; or patients who have developed recurrent biliary stricture after initial resolution.
Patients who have received a sufficient explanation of the study, fully understood its contents, and provided written informed consent to participate of their own free will.
Key exclusion criteria
Pregnant women.
Patients deemed unsuitable for participation in this study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo University Hospital, Faculty of Medicine, Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo University Hospital, Faculty of Medicine, Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
y.yamaguchi.nj@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2026 | Year | 07 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective observational study evaluating the efficacy and safety of endoscopic laser treatment performed using peroral cholangioscopy for patients with benign biliary strictures.
Management information
Registered date
| 2026 | Year | 07 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071220
