UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060161 |
|---|---|
| Receipt number | R000068808 |
| Scientific Title | An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/22 15:48:55 |
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Basic information
Public title
An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Acronym
An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Scientific Title
An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Scientific Title:Acronym
An Exploratory Study on the Association Between Bile, Duodenal Fluid, and Tissue Specimens and the Formation of Biliary Sludge and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
Region
| Japan |
Condition
Condition
Common bile duct stones, Benign biliary strictures, Malignant biliary strictures caused by pancreatic cancer or distal bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the factors and underlying mechanisms involved in biliary sludge formation and biliary stent occlusion by analyzing bile, duodenal fluid, and bile duct tissue.
Basic objectives2
Others
Basic objectives -Others
To elucidate the factors and underlying mechanisms involved in biliary sludge formation and biliary stent occlusion by analyzing bile, duodenal fluid, and bile duct tissue.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the impact of bile components and the biliary microbiota, the duodenal fluid microbiota, and inflammatory and pathological changes in the bile duct and pancreas on biliary sludge formation and biliary stent patency.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients aged 20 years or older.
2 Patients who undergo ERCP at our institution and meet at least one of the following criteria.
3 Patients who have been fully informed of the purpose and methods of this study and who have provided written informed consent.
Key exclusion criteria
1 Patients presenting with severe (Grade III) acute cholangitis, as defined by the Tokyo Guidelines 2018.
2 Patients unable to provide written informed consent for participation in this study.
3 Patients who are deemed inappropriate for participation in this study at the discretion of the attending physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tsukuba Universiy
Division name
Department of Gastroenterology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3900
kii.gast@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Hagiwara |
Organization
Tsukuba Universiy
Division name
Department of Gastroenterology
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL
029-853-3900
Homepage URL
hagiwara.yuya.es@ms.hosp.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba Universiy
Institute
Department
Personal name
Funding Source
Organization
Tsukuba Universiy
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
Institutional Review Board (IRB) of the University of Tsukuba Hospital
Address
1-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.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 | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following data will be collected and analyzed:
Bile components (including bile acids, bilirubin, proteins, inflammatory cytokines, etc.) and the biliary microbiota.
Microbiota of duodenal fluid.
Inflammatory and histopathological changes in the bile duct and pancreas.
In addition, the following clinical data will be collected:
Disease diagnosis, baseline characteristics, and background factors.
Treatment details, including stone removal and type of biliary stent placement.
Presence or absence of stent occlusion and duration of biliary stent patency.
Interventions performed at repeat ERCP.
Results of microbiological cultures.
Imaging findings and pathological findings.
Clinical course and occurrence of complications.
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068808
