UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000033652
Receipt number	R000038368
Scientific Title	A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases
Date of disclosure of the study information	2018/08/07
Last modified on	2020/08/08 10:23:51

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Basic information

Public title

A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases

Acronym

A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases

Scientific Title

A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases

Scientific Title:Acronym

A retrospective study on the pathological diagnostic ability of endoscopic tissue sampling for biliary tract diseases

Region

Japan

Condition

cholangiocarcinoma benign biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the efficacy and safety of EUS-FNA and ERCP for diagnosing biliary tract disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

To evaluate diagnostic performances of EUS-FNA and ERCP tissue sampling based on pathological evaluation.

Key secondary outcomes

To evaluate the adverse events of EUS-FNA, ERCP for biliary tract disease.
To evaluate the factors related to accuracy of EUS-FNA, ERCP tissue sampling for biliary tract cancer.

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

Men and women aged 20 years or older at the time of performing the endoscopic procedure.
Patients who underwent pathologic diagnosis for biliary tract mass and / or bile duct stricture.

Key exclusion criteria

Patients who were refused to participate in the opt-out poster.
Patients recieved medication for malignant tumor within 1 month prior to acquiring the pathological specimen.
Patients whom researcher considered inappropriate.

Target sample size

Research contact person

Name of lead principal investigator

1st name Takumi

Middle name

Last name Onoyama

Organization

Faculty of Medicine, Tottori University

Division name

Division of Gastroenterology and Nephrology, Department of Multidisciplinary Internal Medicine

Zip code

683-8504

Address

36-1 Nishi-cho, Yonago

TEL

0859-38-6527

Email

golf4to@yahoo.co.jp

Public contact

Name of contact person

1st name Takumi

Middle name

Last name Onoyama

Organization

Faculty of Medicine, Tottori University

Division name

Division of Gastroenterology and Nephrology, Department of Multidisciplinary Internal Medicine

Zip code

683-8504

Address

36-1 Nishi-cho, Yonago

TEL

0859-38-6527

Homepage URL

Email

golf4to@yahoo.co.jp

Sponsor or person

Institute

Faculty of Medicine, Tottori University

Institute

Department

Personal name

Funding Source

Organization

Faculty of Medicine, Tottori University

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

The institutional review board of Tottori University

Address

Nishi-cho 86

Tel

0859-33-1112

Email

me-rinshoukenkyu@ml.adm.tottori-u.ac.jp

Secondary IDs

YES

Study ID_1

17A095

Org. issuing International ID_1

The institutional review board of Tottori University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 07 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

doi: 10.3390/jcm8040417

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

Main results already published

Date of protocol fixation

2017 Year 12 Month 28 Day

Date of IRB

2017 Year 11 Month 20 Day

Anticipated trial start date

2018 Year 08 Month 07 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Case control study
between October 2011 and March 2017.
sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of endoscopic tissue sampling.
adverse event of endoscopic tissue sampling.

Management information

Registered date

2018 Year 08 Month 07 Day

Last modified on

2020 Year 08 Month 08 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038368

Research Plan
Registered date	File name
2020/08/08	17A095_臨床研究計画書_胆道腫瘍_病理学診断.docx

Research case data specifications
Registered date	File name
2020/08/08	症例報告書form.xlsx

Research case data
Registered date	File name
2020/08/08	症例報告書.xlsx