UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062189 |
|---|---|
| Receipt number | R000071166 |
| Scientific Title | Dual-operator versus single-operator peroral cholangioscopy for indeterminate biliary stricture: a multicentre randomised controlled trial |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/09 17:28:43 |
* 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
Comparison of the textbook diagnostic outcome of dual-operator and single-operator peroral cholangioscopy
Acronym
DUAL-POCS Trial
Scientific Title
Dual-operator versus single-operator peroral cholangioscopy for indeterminate biliary stricture: a multicentre randomised controlled trial
Scientific Title:Acronym
DUAL-POCS Trial
Region
| Japan |
Condition
Condition
Biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare single-operator and dual-operator peroral cholangioscopy in patients with biliary stricture and to evaluate the achievement rate of textbook diagnostic outcome during the initial ERCP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Textbook diagnostic outcome at the initial ERCP.
Textbook diagnostic outcome is defined as fulfilling all of the following criteria:
1. Completion within 10 minutes using the assigned POCS strategy, including insertion of the cholangioscope into the bile duct, observation of the entire target lesion, and targeted biopsy until at least macroscopically visible specimens are obtained.
2. No crossover to the other operator strategy.
3. No diagnostic re-ERCP or other invasive diagnostic procedure due to insufficient diagnosis within 60 days after the initial ERCP.
4. No procedure-related adverse event of moderate or greater severity within 30 days.
Key secondary outcomes
1. POCS insertion time
2. Crossover rate
3. Type and frequency of adverse events
4. Total procedure time
5. Diagnostic performance of POCS-guided biopsy
6. Rate of diagnostic re-ERCP or other invasive diagnostic procedures within 60 days
7. Cost
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Single-operator POCS group.
After biliary cannulation, papillary treatment, and guidewire placement, a single operator manipulates both the duodenoscope and the cholangioscope. The cholangioscope is inserted into the bile duct, the target lesion is observed, and targeted biopsy is performed. If the assigned procedure is not completed within 10 minutes, crossover to the dual-operator method is permitted.
Interventions/Control_2
Dual-operator POCS group.
After biliary cannulation, papillary treatment, and guidewire placement, one operator manipulates the duodenoscope and another operator manipulates the cholangioscope. The cholangioscope is inserted into the bile duct, the target lesion is observed, and targeted biopsy is performed. If the assigned procedure is not completed within 10 minutes, crossover to the single-operator 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 biliary stricture.
2. Age 18 years or older and less than 99 years at enrollment.
3. Patients with normal anatomy or Billroth I reconstruction.
4. Written informed consent obtained from the patient.
Key exclusion criteria
1. Surgically altered anatomy other than Billroth I reconstruction.
2. Uncontrolled cholangitis.
3. ECOG performance status 4.
4. Patients with bleeding tendency.
Target sample size
270
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
+81-72-683-1221
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
+81-72-683-1221
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
Yokohama City University Medical Center
Okayama University Hospital
Aichi Medical University Hospital
Kansai Medical University Hospital
Osaka Metropolitan University Hospital
Kagawa University
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
+81-72-683-1221
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 | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 08 | 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=R000071166
