UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060559 |
|---|---|
| Receipt number | R000069273 |
| Scientific Title | Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2026/02/03 |
| Last modified on | 2026/02/03 11:18:59 |
* 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
Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial
Acronym
Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial
Scientific Title
Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial
Scientific Title:Acronym
Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
Diseases for which ERC was attempted for the purpose of cholangiography
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine and compare the first session technical success for biliary access of EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
To determine the adverse event rates of EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
To determine the rate of rescue procedures needed in patients with failed biliary access by the assigned study technique
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The first session technical success for biliary access by EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
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
EUS-guided rendezvous technique for difficult biliary cannulation
Interventions/Control_2
Precut papillotomy as the standard salvage technique for difficult biliary cannulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation
Native major papilla
Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast
Written informed consent available
Key exclusion criteria
Unable to provide written informed consent
Contraindications for endoscopy due to comorbidities
Prior biliary sphincterotomy
Altered upper gastrointestinal or biliary anatomy or duodenal obstruction
Common bile duct diameter < 6mm on pre-endoscopy imaging
Papillary orifice not identifiable or accessible on endoscopic view before biliary cannulation
Uncorrectable coagulopathy (INR > 1.5) and thrombocytopenia (platelet < 50,000) by blood product transfusion
Pregnant patients
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama
Division name
Third department of internal medicine
Zip code
930-0152
Address
2630 Sugitani Toyama city Toyama pref. Japan
TEL
076-434-7301
yasudaic@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Hayashi |
Organization
University of Toyama
Division name
Third department of internal medicine
Zip code
930-0152
Address
2630 Sugitani Toyama city Toyama pref. Japan
TEL
076-434-7301
Homepage URL
hayashi@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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 Toyama
Address
2630 Sugitani Toyama city Toyama pref. Japan
Tel
076-434-7301
hayashi@med.u-toyama.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 | 02 | Month | 03 | 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 | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069273
