UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042435
Receipt number R000048444
Scientific Title Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/12 22:04:38

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Basic information

Public title

Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture

Acronym

Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture

Scientific Title

Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture

Scientific Title:Acronym

Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture

Region

Japan


Condition

Condition

biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

evaluate additional effect of peroral cholangioscope to computed tomography on diagnosis of biliary strictures and tumor spread

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in agreement between the evaluation of CT and ERCP images and that with POCSadded to the final diagnosis

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) A case in which biliary stricture was diagnosed by dynamic CT and ERCP was performed at our hospital for the purpose of benign / malignant diagnosis or tumor spread
2) performing a four-phase CT without pneumobilia and biliary stent.
3) using video cholangioscope.
4) performing CT and POCS within sixty days.

Key exclusion criteria

1) pancreatic disease and tumor of duodenal papilla diagnosed without POCS.
2) patients who did not undergo radical resection or were treated before surgery for malignant disease.
3) patients who underwent follow-up of less than three years for benign disease.
4) anastomotic stricture diagnosed with medical history.
5) biliary strictures by primary hepatic cancer and metastatic tumor.
6) pancreaticobiliary maljunction without findings to suggest malignancy.
7) A case in which there was an offer to refuse participation in this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Kato

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Gastroenterology

Zip code

260-8677

Address

Inohana 1-8-1, Chiba-City, Japan.

TEL

043-222-7171

Email

kato.naoya@chiba-u.jp


Public contact

Name of contact person

1st name Yukiko
Middle name
Last name Shima

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Gastroenterology

Zip code

260-8677

Address

Inohana 1-8-1, Chiba-City, Japan.

TEL

043-222-7171

Homepage URL


Email

shimako1029@gmail.com


Sponsor or person

Institute

Department of Gastroenterology, Graduate School of Medicine, Chiba University.

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology, Graduate School of Medicine, Chiba 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

Chiba University Certified Review Board

Address

Inohana 1-8-1, Chiba-City, Japan.

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

3608

Org. issuing International ID_1

Chiba University Certified Review Board

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 11 Month 13 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

52

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

2019 Year 11 Month 27 Day

Date of IRB

2019 Year 12 Month 24 Day

Anticipated trial start date

2019 Year 12 Month 25 Day

Last follow-up date

2020 Year 09 Month 09 Day

Date of closure to data entry

2020 Year 09 Month 09 Day

Date trial data considered complete

2020 Year 09 Month 09 Day

Date analysis concluded



Other

Other related information

This research is retrospective cohort study.


Management information

Registered date

2020 Year 11 Month 12 Day

Last modified on

2020 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name