UMIN-CTR Clinical Trial

Basic information
Public title	Association between biliopancreatic diseases and intestinal microbiota
Acronym	Association between biliopancreatic diseases and intestinal microbiota
Scientific Title	Association between biliopancreatic diseases and intestinal microbiota
Scientific Title:Acronym	Association between biliopancreatic diseases and intestinal microbiota
Region	Japan

Condition
Condition	biliopancreatic diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between biliopancreatic diseases and intestinal microbiota and to obtain clinically applicable knowledge.
Basic objectives2	Others
Basic objectives -Others	Differences in bacterial flora between various diseases, clinical findings (jaundice, cholangiopancreatic duct dilatation, etc.), and relationships with blood sampling data and bile acids will be clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the relationship between biliopancreatic lesions and duodenal mucosal surface microbiota.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Collect bile and scrape the lesion surface and duodenal mucosa with a brush.
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Among adults aged 20 years or older who undergo endoscopic retrograde pancreatic cholangiography (ERCP) for bile duct and pancreatic diseases including papillary disease at our hospital, those who understand the contents of this study and have given written consent to participate in the study are eligible.
Key exclusion criteria	Patients who wish to be excluded from the study If the principal investigator or sub-investigator determines that the patient is ineligible to participate in the study for any other reason.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kawashima Middle name Last name Hiroki
Organization	Nagoya University Hospital
Division name	Department of Endoscopy,
Zip code	4668560
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL	0527412111
Email	h-kawa@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Honda Middle name Last name Takashi
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4668560
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
TEL	0527412111
Homepage URL
Email	honda@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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	Ethics Committee
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8560, Japan
Tel	0527412111
Email	ytakada@med.nagoya-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	2021 Year 08 Month 23 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	2021 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 23 Day
Last follow-up date	2024 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	2021 Year 08 Month 23 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051675