UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013960
Receipt number R000016264
Scientific Title The effectiveness of CT in endoscopic detection of source in diverticular bleeding of colon
Date of disclosure of the study information 2014/05/15
Last modified on 2014/05/14 21:43:08

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Basic information

Public title

The effectiveness of CT in endoscopic detection of source in diverticular bleeding of colon

Acronym

The effectiveness of CT in endoscopic detection of source in diverticular bleeding of colon

Scientific Title

The effectiveness of CT in endoscopic detection of source in diverticular bleeding of colon

Scientific Title:Acronym

The effectiveness of CT in endoscopic detection of source in diverticular bleeding of colon

Region

Japan


Condition

Condition

diverticular bleeding of colon

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of CT in detection of bleeding source endoscopically in diverticular hemorrhage

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

endoscopic identification rate of bleeding source in patients with positive CT and negative

Key secondary outcomes

1 detection rate of CT
2 early rebleeding rate in patients with positive CT and negative
3 variation in detection rate of CT over time
4 variation in detection rate of colonoscopy over time


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients who have hematochezia and are suspected of diverticular bleeding of the colon

Key exclusion criteria

1.Patients who does not provide consent
2.Patients with diagnosis of bowel inflammation including IBD
3.Patients who had severe disease in heart, liver, kidney or nervous system or psychiatric disorder
4.Patients with pregnancy
5.Patients who can not receive injection of contrast agent
6.Patients with hemorrhagic shock or with suspected hemorrhagic shock
7.Patients who was diagnosed with other intestinal bleeding such as colon cancer, hemorroids with bleeding, upper gastrointestinal bleeding, and small-bowel bleeding

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shotaro Umezawa

Organization

Yokohama City University Hospital

Division name

Division of Endoscopy

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

umezawa-ykh@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shotaro Umezawa

Organization

Yokohama City University Hospital

Division name

Division of Endoscopy

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

umezawa-ykh@umin.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yokohama City 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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 15 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

2014 Year 05 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information


Management information

Registered date

2014 Year 05 Month 14 Day

Last modified on

2014 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016264


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name