UMIN-CTR Clinical Trial

Basic information
Public title	Research on bile duct biopsy for biliary tract diseases
Acronym	Research on bile duct biopsy for biliary tract diseases
Scientific Title	Research on bile duct biopsy for biliary tract diseases
Scientific Title:Acronym	Research on bile duct biopsy for biliary tract diseases
Region	Japan

Condition
Condition	Extrahepatic bile duct cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the results and safety of biopsy for bile duct stenosis using an endoscopic introducer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate of Mapping Biopsy using endoscopic introducer (success rate of biopsy of targeted bile duct branch against expected operation)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Bile duct biopsy using an endoscopic introducer
Interventions/Control_2	Bile duct biopsy without an endoscopic introducer
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	Patients who are suspected of having bile duct stenosis by imaging diagnosis such as CT or MRI and require ERCP. Patients who have given written consent to participate in this study.
Key exclusion criteria	Patients with poorly controlled infections. Patients with severe drug allergy. Pregnant or potentially pregnant and lactating women. Patients with severe mental disorders. Cases that the principal investigator or sub-investigator deems inappropriate for the safe conduct of this study.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Kawashima
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	0527442602
Email	h-kawa@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Yamada
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Zip code	4668550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	0527442602
Homepage URL
Email	kentaymd@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya 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	Ethics Committee
Address	65, Tsuruma-cho, Showa-ku, Nagoya
Tel	0527412111
Email	ethics@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 07 Month 01 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 06 Month 11 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2025 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 06 Month 11 Day
Last modified on	2021 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050851