UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062190 |
|---|---|
| Receipt number | R000071167 |
| Scientific Title | A multicentre randomized trial to evaluate the superiority of basket catheter over balloon catheter for endoscopic stone extraction in distal common bile duct stones |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/09 17:25:30 |
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Basic information
Public title
Comparison of balloon catheter and spiral basket catheter for endoscopic stone extraction in distal common bile duct stones
Acronym
Basket vs Balloon Trial
Scientific Title
A multicentre randomized trial to evaluate the superiority of basket catheter over balloon catheter for endoscopic stone extraction in distal common bile duct stones
Scientific Title:Acronym
Basket vs Balloon Trial
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
To compare the treatment outcomes of spiral basket catheter and balloon catheter for endoscopic extraction of common bile duct stones measuring 10 mm or smaller with distal location or impacted tendency, and to evaluate the superiority of the spiral basket-first strategy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Textbook treatment success at the initial ERCP.
Textbook treatment success is defined as complete common bile duct stone extraction within 10 minutes from insertion of the assigned extraction device into the bile duct, using only the assigned device, with no residual stones on final cholangiography, no addition of or switch to another extraction device within 10 minutes, no unplanned re-ERCP or additional biliary intervention related to common bile duct stone treatment within 28 days after ERCP, and no ERCP-related adverse event within 28 days.
Key secondary outcomes
1. Stone extraction procedure time
2. Number of device strokes
3. Type and frequency of adverse events
4. Total procedure time
5. Total cost of treatment devices
6. Complete stone extraction rate within 10 minutes
7. Rate of unplanned re-ERCP or additional biliary intervention related to common bile duct stone treatment within 28 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balloon catheter group. After biliary cannulation and confirmation of stones by cholangiography, endoscopic sphincterotomy is performed, followed by stone extraction using the assigned balloon catheter. If complete stone extraction cannot be achieved within 10 minutes from insertion of the assigned device into the bile duct, switching to another extraction device or another treatment method is permitted.
Interventions/Control_2
Spiral basket catheter group. After biliary cannulation and confirmation of stones by cholangiography, endoscopic sphincterotomy is performed, followed by stone extraction using the assigned spiral basket catheter. If complete stone extraction cannot be achieved within 10 minutes from insertion of the assigned device into the bile duct, switching to another extraction device or another treatment method is permitted.
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Hospitalized patients with common bile duct stones at the participating institutions.
2. Stones located distally or showing impacted tendency.
3. Age 18 years or older and less than 99 years at enrollment.
4. Patients with normal anatomy or Billroth I reconstruction.
5. Written informed consent obtained from the patient.
Key exclusion criteria
1. Surgically altered anatomy other than Billroth I reconstruction.
2. ECOG performance status 4.
3. Patients with bleeding tendency.
4. Patients with concomitant intrahepatic bile duct stones.
5. Patients in whom stones are not confirmed by cholangiography.
Target sample size
390
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Pancreatobiliary Advanced Medical Center
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Pancreatobiliary Advanced Medical Center
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Pancreatobiliary Advanced Medical Center, Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Medical University Medical Center, Department of Gastroenterology and Hepatology
Osaka Metropolitan University Hospital, Department of Gastroenterology
Osaka Rosai Hospital, Department of Gastroenterology
Sendai City Medical Center, Sendai Open Hospital, Department of Gastroenterology, Hepatology and Pancreatobiliary Medicine
Yokohama City University Medical Center, Gastroenterological Center
Nara Medical University, Department of Gastroenterology
Higashihiroshima Medical Center, Department of Gastroenterology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Research Ethics Committee
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
Tel
072-683-1221
rinri@ompu.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 | 20 | 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 | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 01 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071167
