UMIN-CTR Clinical Trial

Basic information
Public title	Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Acronym	PBM
Scientific Title	Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Scientific Title:Acronym	PBM
Region	Japan

Condition
Condition	Research in Progress
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Pathologically examine the effects of different confluent forms in PBM on the biliary epithelium
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical data and pathological samples of 24 patients were collected, and statistical and pathological studies have been completed.
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	1 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	PBM patients who underwent surgery at our hospital.
Key exclusion criteria	PBM patients who underwent surgery at another hospital.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Horiike
Organization	Japanese Red Cross Society Wakayama Medical Center
Division name	pediatric surgery
Zip code	6408558
Address	4-20 Komatsubara-dori, Wakayama
TEL	+81-73-422-4171
Email	masakihoriike1031@gmail.com

Public contact
Name of contact person	1st name Masaki Middle name Last name Horiike
Organization	Japanese Red Cross Society Wakayama Medical Center
Division name	pediatric surgery
Zip code	6408558
Address	4-20 Komatsubara-dori, Wakayama
TEL	+81-73-422-4171
Homepage URL	https://www.wakayama-med.jrc.or.jp/
Email	masakihoriike1031@gmail.com

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Osaka City University
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Society Wakayama Medical Center
Address	4-20 Komatsubara-dori, Wakayama
Tel	+81-73-422-4171
Email	masakihoriike1031@gmail.com

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 03 Month 31 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	Suspended
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry	2022 Year 12 Month 01 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	observational

Management information
Registered date	2020 Year 12 Month 10 Day
Last modified on	2022 Year 12 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048760