UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057935 |
|---|---|
| Receipt number | R000064934 |
| Scientific Title | Relationship Between Biliary Stent Occlusion, Diet, Bile Acids and Gut Microbime in Malignant Distal Biliary Obstrution |
| Date of disclosure of the study information | 2025/05/22 |
| Last modified on | 2025/05/22 08:35:59 |
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Basic information
Public title
Relationship Between Biliary Stent Occlusion, Diet, Bile Acids and Gut Microbime in Malignant Distal Biliary Obstrution
Acronym
Relationship Between Biliary Stent Occlusion, Diet, Bile Acids and Gut Microbime in Malignant Distal Biliary Obstrution
Scientific Title
Relationship Between Biliary Stent Occlusion, Diet, Bile Acids and Gut Microbime in Malignant Distal Biliary Obstrution
Scientific Title:Acronym
Relationship Between Biliary Stent Occlusion, Diet, Bile Acids and Gut Microbime in Malignant Distal Biliary Obstrution
Region
| Japan |
Condition
Condition
Pancreatic cancer, Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between biliary stent occlusion and bile acids, gut microbiome, and dietary intake in patients with pancreatic and biliary tract cancer after biliary stent placement.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between biliary stent occlusion and bile acids, gut microbiome, and dietary intake.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between biliary stent occlusion and bile acid composition, gut microbiota profile, and dietary patterns.
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 with pancreatic or biliary tract cancer who have malignant biliary stricture in the common bile duct to common hepatic duct
2. Patients requiring initial transpapillary endoscopic biliary drainage due to biliary obstruction
Key exclusion criteria
1. Patients with duodenal stricture at or distal to the major papilla
2. Patients on multiple antithrombotic agents (oral, intravenous, or subcutaneous) where appropriate management per clinical guidelines for duodenal mucosal sampling is not feasible
3. Patients with coagulation disorders
4. Patients with definitive diagnosis of cholangitis according to Tokyo Guidelines 2018
5. Patients who received antibiotics within one month prior to ERCP
6. Patients deemed unsuitable for the study by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu Universiy
Division name
Department of Medicine, Division of Gastroenterology and Hepatology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
+81-263-37-2634
m040063b@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu Universiy
Division name
Department of Medicine, Division of Gastroenterology and Hepatology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
+81-263-37-2634
Homepage URL
m040063b@yahoo.co.jp
Sponsor or person
Institute
Shinshu Universiy
Department of Medicine, Division of Gastroenterology and Hepatology
Akira Nakamura
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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 of Shinshu University school of medicine
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
+81-263-37-2572
mdrinri@shinshu-u.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
| 2025 | Year | 05 | Month | 22 | 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
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected for the following items:
Subject characteristics: Gender, age, height, weight, comorbidities, past medical history, history of present illness, current medications, diagnosis
Subjective and objective symptoms
Bile analysis: Bile acid analysis, microbiome analysis, and additional metabolome analysis based on bile acid results
Duodenal mucosa microbiome analysis
Blood tests: RBC, Hb, Hct, WBC, Plt, TP, Alb, T-Bil, D-Bil, ALP, AST, ALT, ganma-GTP, LDH, BUN, Cre, Na, K, Cl, Ca, P, AMY, P-AMY, TC, LDL-C, HDL-C, TG, HbA1c, CRP, fasting blood glucose, erythrocyte sedimentation rate, PT, APTT, fibrinogen, approximately 10ml of stored blood sample
Dietary intake (3 days within a 4-week period)
Management information
Registered date
| 2025 | Year | 05 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064934
