UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033801
Receipt number R000038509
Scientific Title A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)
Date of disclosure of the study information 2018/09/01
Last modified on 2019/12/25 12:28:48

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Basic information

Public title

A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)

Acronym

A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)

Scientific Title

A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)

Scientific Title:Acronym

A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)

Region

Japan


Condition

Condition

biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the accuracy of cholangioscopy and confocal laser endomicroscopy imaging on the diagnosis of biliary stricture

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

accuracy of diagnosis

Key secondary outcomes

findings of cholangioscopy and confocal laser endomicroscopy imaging


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Patients with biliary stricture undergo cholangioscopy and confocal laser endomicroscopy imaging for diagnosis,then they will be histologically evaluated.

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

The patient with biliary stricture who needs diagnosis or treatment by ERCP.

Key exclusion criteria

The patient with no other serious complications and cholangitis.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tanisaka Yuki

Organization

Saitama Medical University International Medical Center

Division name

Department of gastroenterology

Zip code


Address

1397-1, Yamane, Hidaka, Saitama

TEL

042-984-4111

Email

tanisaka1205@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tanisaka Yuki

Organization

Saitama Medical University International Medical Center

Division name

Department of gastroenterology

Zip code


Address

1397-1, Yamane, Hidaka, Saitama

TEL

042-984-4111

Homepage URL


Email

tanisaka1205@gmail.com


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Boston Scientific Corporation

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


Address


Tel


Email



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

2018 Year 09 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

Completed

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 09 Month 06 Day

Anticipated trial start date

2018 Year 09 Month 06 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 19 Day

Last modified on

2019 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name