UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062135 |
|---|---|
| Receipt number | R000071101 |
| Scientific Title | Precut-first Strategy versus Direct EUS-guided Rendezvous Strategy for Difficult Biliary Cannulation: A Multicenter Retrospective Study |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/03 18:04:58 |
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Basic information
Public title
Precut-first Strategy versus Direct EUS-guided Rendezvous Strategy for Difficult Biliary Cannulation: A Multicenter Retrospective Study
Acronym
Precut-first vs. Direct EUS-RV for Difficult Biliary Cannulation: A Multicenter Retrospective Study
Scientific Title
Precut-first Strategy versus Direct EUS-guided Rendezvous Strategy for Difficult Biliary Cannulation: A Multicenter Retrospective Study
Scientific Title:Acronym
Precut-first vs. Direct EUS-RV for Difficult Biliary Cannulation: A Multicenter Retrospective Study
Region
| Japan |
Condition
Condition
Difficult Biliary Cannulation (Endoscopic Retrograde Cholangiopancreatography in Naive Papilla)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the optimal salvage strategy by analyzing the clinical outcomes of precut papillotomy and EUS-guided rendezvous (EUS-RV) in real-world practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Technical success rate on the day of the initial salvage procedure (Successful biliary cannulation within the first session)
Key secondary outcomes
1) Cumulative success rate of the step-by-step salvage strategy
2) Technical success rate of each individual salvage procedure (precut papillotomy, EUS-RV)
3) Incidence of adverse events, including post-ERCP pancreatitis (PEP)
4) Procedure time for each salvage technique and total procedure time to final success
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent precut papillotomy or endoscopic ultrasound-guided rendezvous (EUS-RV) for difficult biliary cannulation in a naive papilla at a participating institution between April 1, 2017, and March 31, 2026.
2) Patients who did not express refusal to participate in the study through the opt-out procedure.
Key exclusion criteria
1) Patients with altered gastrointestinal anatomy after surgery, excluding Billroth-I reconstruction.
2) Patients with impacted stones in the papilla.
3) Patients in whom the major duodenal papilla cannot be endoscopically visualized.
4) Patients deemed inappropriate for inclusion by the principal investigator.
Target sample size
435
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Fukuda |
Organization
University of Tsukuba Hospital
Division name
Department of Gastroenterology
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3218
fukuda.soma.vj@ms.hosp.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Soma |
| Middle name | |
| Last name | Fukuda |
Organization
University of Tsukuba Hospital
Division name
Department of Gastroenterology
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-851
Homepage URL
fukuda.soma.vj@ms.hosp.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Soma Fukuda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital Clinical Research Ethics Committee
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-7668
fukuda.soma.vj@ms.hosp.tsukuba.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R08-069
Org. issuing International ID_1
University of Tsukuba Hospital Clinical Research Ethics Committee
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 | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071101
