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 |
* 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
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
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
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
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
