UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060734 |
|---|---|
| Receipt number | R000069483 |
| Scientific Title | Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope: Japan multicenter trial |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/23 13:33:16 |
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Basic information
Public title
Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope:
Japan multicenter trial
Acronym
Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope:
Japan multicenter trial
Scientific Title
Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope:
Japan multicenter trial
Scientific Title:Acronym
Cholangioscopy-guided lithotripsy Randomized comparison with the Use of mechanical lithotripsy for Stones with High-difficulty in patients with Roux-en-Y gastrectomy using balloon enteroscope:
Japan multicenter trial
Region
| Japan |
Condition
Condition
bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment outcomes of cholangioscopy-guided lithotripsy and mechanical lithotripsy using a mechanical lithotripter in patients with Roux-en-Y reconstruction after gastrectomy in a multicenter randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stone clearance rate during the initial session
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mechanical lithotripsy
Interventions/Control_2
Peroral cholangioscopy guided lithotriptsy
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
1. Patients with bile duct stones detected by imaging examinations such as abdominal ultrasonography, CT, MRI, or other modalities
2. Patients who have undergone Roux-en-Y reconstruction after gastrectomy and are scheduled to undergo endoscopic stone removal using balloon-assisted endoscopy
3. Patients with stones measuring 15 mm or more in maximum diameter, or with multiple stones (three or more) including at least one stone measuring 10 mm or more in maximum diameter (as measured on pre-procedural imaging)
4. Patients aged 20 years or older at the time of informed consent
5. Patients with an ECOG Performance Status score of 0-2
6. Patients from whom written informed consent for participation in this study has been obtained
Key exclusion criteria
1. Patients who have not undergone gastrointestinal reconstruction surgery, or who have undergone reconstruction procedures other than Roux-en-Y reconstruction after gastrectomy
2. Patients in whom discontinuation or substitution of antithrombotic agents is required but cannot be performed when conducting high bleeding-risk endoscopic procedures, as described in the guidelines for gastrointestinal endoscopy in patients receiving antithrombotic or anticoagulant therapy. In addition, patients with valvular atrial fibrillation receiving warfarin whose anticoagulation cannot be maintained within the therapeutic range
3. Patients with severe cholangitis (TG18 grade III) in whom cholangioscopic procedures are considered high risk
4. Patients with poor general condition (ECOG Performance Status score 3 or4)
5. Female patients who may be pregnant
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Shomei |
| Middle name | |
| Last name | Ryozawa |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
0429844111
tanisaka1205@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tanisaka |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
3501114
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
0429844111
Homepage URL
tanisaka1205@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama, JAPAN
Tel
0429844111
tanisaka1205@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
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Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 23 | Day |
Last modified on
| 2026 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069483
