UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled study on the effects of endoscopic treatment and barium impaction therapy against colonic diverticular bleeding
Title of the study (Brief title)	Endoscopic treatment vs. barium impaction therapy against colonic diverticular bleeding
Region	Japan

Condition
Condition	colonic diverticular bleeding
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparison of efficacy of both treatment measures in hemostasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	hemostasis ratio 48h after treatment
Key secondary outcomes	hemostasis ratio 30d after treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	endoscopic hemostasis
Interventions/Control_2	barium impaction
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	Cases with fresh rectal bleeding who have a former history of colonic diverticular bleeding
Key exclusion criteria	failute to obtain written informed consent
Target sample size	50

Research contact person
Name of lead principal investigator	Nobuyuki Matsuhashi
Organization	NTT Medical center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL	03-3448-6248
Email	nmatuha-tky@umin.ac.jp

Public contact
Name of contact person	Nobuyuki Matsuhashi
Organization	NTT Medical center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL	03-3448-6248
Homepage URL
Email	nmatuha-tky@umin.ac.jp

Sponsor
Institute	NTT Medical center Tokyo
Institute
Department

Funding Source
Organization	NTT Medical center Tokyo
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 06 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 06 Month 08 Day
Anticipated trial start date	2011 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 06 Month 28 Day
Last modified on	2018 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006798