UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020193
Receipt number R000023321
Scientific Title Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location
Date of disclosure of the study information 2016/12/31
Last modified on 2017/08/23 21:33:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location

Acronym

Peroral cholangioscopy or EUS-guided biopsy for diagnosis of biliary stricture

Scientific Title

Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location

Scientific Title:Acronym

Peroral cholangioscopy or EUS-guided biopsy for diagnosis of biliary stricture

Region

Asia(except Japan)


Condition

Condition

Malignant Biliary Stricture

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of a diagnostic approach using POC-guided forceps biopsy or EUS-FNAB according to the location of stricture in suspected MBS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy of POC-guided biopsy and EUS-FNAB for indeterminate biliary stricture

Key secondary outcomes

Accuracy of initial TPB
Procedure technical success
Diagnostic yields of POC-guided biopsy and EUS-FNAB for indeterminate biliary stricture
Adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

POC-guided intraductal forceps biopsy for indeterminate MBS in proximal bile duct

Interventions/Control_2

EUS-guided FNAB for indeterminate MBS in distal bile duct

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

18 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

1. Suspected MBS diagnosed by cross sectional imaging study
2. Clinical findings of obstructive jaundice and/or cholangitis

Key exclusion criteria

1. Bleeding tendency (INR>1.5 or platelet count < 60,000/mm3)
2. Inability to give informed consent

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jong Ho Moon

Organization

SoonChunHyang University School of Medicine

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code


Address

Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea

TEL

+82-32-621-5094

Email

jhmoon@schmc.ac.kr


Public contact

Name of contact person

1st name
Middle name
Last name Yun Nah Lee

Organization

SoonChunHyang University School of Medicine

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code


Address

Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma

TEL

+82-32-621-5094

Homepage URL


Email

yunnah@schmc.ac.kr


Sponsor or person

Institute

SoonChunHyang University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

SoonChunHyang University School of Medicine

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


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

2016 Year 12 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

No longer recruiting

Date of protocol fixation

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 24 Day

Last follow-up date

2016 Year 06 Month 08 Day

Date of closure to data entry

2017 Year 01 Month 04 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 14 Day

Last modified on

2017 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023321


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name