UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042732
Receipt number R000048777
Scientific Title Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment
Date of disclosure of the study information 2020/12/11
Last modified on 2023/12/14 16:26:47

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Basic information

Public title

Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment

Acronym

Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment

Scientific Title

Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment

Scientific Title:Acronym

Study on pathophysiology and clinical features of intractable and rare hepatobiliary and pancreatic disease and prognosis after treatment

Region

Japan


Condition

Condition

pancreaticobiliary maljunction

Classification by specialty

Surgery in general Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of different types of confluence form in pancreaticobiliary maljunction on chronic inflammation and carcinogenesis of the gallbladder epithelium

Basic objectives2

Others

Basic objectives -Others

To be able to infer pathological findings of gallbladder epithelium from the confluence form of pancreaticobiliary maljunction

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between pancreatic duct and bile duct confluent angle, common bile duct morphology, bile duct diameter at the junction site and pathological findings of gallbladder epithelium

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

Patients with pancreaticobiliary maljunctionwho underwent surgery at osaka city university

Key exclusion criteria

Patients with pancreaticobiliary maljunction who were referred to osaka city university after undergoing 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

Osaka City University

Division name

pediatric surgery

Zip code

5458585

Address

1-4-3, Asahi-machi,Abeno-ku Osaka

TEL

0666453841

Email

masakihoriike1031@gmail.com


Public contact

Name of contact person

1st name Masaki
Middle name Horiike
Last name Horiike

Organization

Osaka City University

Division name

pediatric surgery

Zip code

5458585

Address

1-4-3, Asahi-machi,Abeno-ku Osaka

TEL

0666453841

Homepage URL


Email

masakihoriike1031@gmail.com


Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Osaka City University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka City University

Address

1-4-3,Asahi-machi,Abeno-ku Osaka

Tel

0666453841

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

2020 Year 12 Month 11 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

24

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

Completed

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

2022 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2022 Year 12 Month 31 Day


Other

Other related information

observational examination


Management information

Registered date

2020 Year 12 Month 11 Day

Last modified on

2023 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048777


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name