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Name:
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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026865
Receipt No. 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

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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
Email 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
Email turaoka@ntmc-hosp.jp

Sponsor
Institute National Hospital Organization Tokyo Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029250

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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