UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026865 |
|---|---|
| Receipt number | R000029250 |
| Scientific Title | A randomized controlled trial which aim at establishment of standard diagnosis and treatment for colonic diverticular bleeding |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2018/02/22 12:14:40 |
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Basic information
Public title
A randomized controlled trial which aim at establishment of standard diagnosis and treatment for colonic diverticular bleeding
Acronym
A randomized controlled trial for standard diagnosis and treatment for colonic diverticular bleeding (eCT-DivBleed)
Scientific Title
A randomized controlled trial which aim at establishment of standard diagnosis and treatment for colonic diverticular bleeding
Scientific Title:Acronym
A randomized controlled trial for standard diagnosis and treatment for colonic diverticular bleeding (eCT-DivBleed)
Region
| Japan |
Condition
Condition
Colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of urgent colonoscopy performed with or without a prior contrast-enhanced CT examination in patients with colonic diverticular bleeding whose chief complaint is hematochezia without accompanying abdominal pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate of colonic diverticular bleeding points.
Key secondary outcomes
Success rate of endoscopic hemostasis, time from last hematochezia to hemostasis, hemostatic rate classified by time from last hematochezia to colonoscopy, completion rate of colonoscopy, observed rate of extravasation of contrast medium on CT, hospitalization period, re-bleeding rate, additional colonoscopy rate and consequential hemostasis rate, rate of interventional radiology treatment required and consequential hemostasis rate, additional surgery rate and consequential hemostasis rate, incidence rate of adverse event, final diagnosis for cause of hematochezia.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Urgent colonoscopy with a prior contrast-enhanced CT examination
Interventions/Control_2
Urgent colonoscopy alone
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who visited the study institution with hematochezia without accompanying abdominal pain within 24 hours after the last hematochezia, and whose colon diverticula were confirmed by non-contrast-enhanced CT examinations. (*Confirmation by a non-contrast-enhanced CT examination is not required, if existence of diverticula can be confirmed by a past image examination.)
2) 20-84 years old patients at time of acquisition of informed consent.
3) Patients who provided written consents for this study by themselves.
Key exclusion criteria
1) Patients with hemorrhagic shock accompanying severe disturbance of consciousness at the time of visit.
2) Patients who do not improve from hemorrhagic shock even after infusion or transfusion.
3) Patients with confirmed melena.
4) Patients who have renal insufficiency and are determined to be inappropriate for use of contrast medium.
5) Patients taking antidiabetes drug of biguanide type.
6) Patients who are diagnosed as inflammatory bowel disease.
7) Patients with suspected hemorrhoidal bleeding.
8) Patients with performance status of grade2 or more.
9) Patients with contrast medium allergies.
10) Patients who are pregnant, or who are possibly pregnant.
11) Patients who have participated in this study in the past.
12) Patients who the principal investigator or other investigators decided not suitable for participation in this study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Uraoka |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Gastroenterology
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8901, JAPAN
TEL
03-3411-0111
turaoka@ntmc-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Uraoka |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Gastroenterolog
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8901, JAPAN
TEL
03-3411-0111
Homepage URL
turaoka@ntmc-hosp.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029250
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