UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009885
Receipt number R000011580
Scientific Title Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography
Date of disclosure of the study information 2013/01/30
Last modified on 2017/03/02 11:44:05

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Basic information

Public title

Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography

Acronym

Cholangiocarcinoma with slight ascites in EUS

Scientific Title

Prognosis of cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography

Scientific Title:Acronym

Cholangiocarcinoma with slight ascites in EUS

Region

Japan


Condition

Condition

Cholangiocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether slight ascites in preoperative assessment of endoscopic ultrasonography affect the prognosis of patients with cholangiocarcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of the prognosis in cholangiocarcinoma with and without slight ascites in preoperative assessment of endoscopic ultrasonography

Key secondary outcomes

: Detection rate of slight ascites in endoscopic ultrasonography.

: Comparison of the detectability of slight ascites in endoscopic ultrasonography and other imaging modarities.

: Comparison of the prognosis in cholangiocarcinoma with slight ascites in preoperative assessment of endoscopic ultrasonography and malignant cells in peritoneal cytology.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

: Patients with cholangiocarcinoma who underwent the preoperative assessment of endoscopic ultrasonography and surgical resection.

: Patients with written informed consent.

Key exclusion criteria

: Patients with ascites caused by other than cholangiocarcinoma.

: Patients without written informed consent.

: Patients considered ineligible for this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Tsuyuguchi

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Gastroenterology and Nephrology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan

TEL

81-43-222-7171

Email

igaku-rinri@office.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Tsuyuguchi

Organization

Chiba University Hospital

Division name

Department of Gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan

TEL

81-43-222-7171

Homepage URL


Email

igaku-rinri@office.chiba-u.jp


Sponsor or person

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 01 Month 30 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

Open public recruiting

Date of protocol fixation

2012 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing particular


Management information

Registered date

2013 Year 01 Month 28 Day

Last modified on

2017 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011580


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name