UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the safety and efficacy of the treatment of polidocanol injection for vascular lesions in the small bowel.
Title of the study (Brief title)	Study on the safety and efficacy of polidocanol injection
Region	Japan

Condition
Condition	Vascular lesions in the small bowel
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of polidocanol injection for the treatment of vascular lesions in the small bowel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate Changes in hemoglobin concentration before and after polidocanol injection
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Polidocanol injection for the treatment of vascular lesions in the small bowel
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with comfirmed vascular lesion in the small bowel and having at least 1 of following conditions; overt gastrointestinal bleeding, iron deficient anemia or positive fecal occult blood test.
Key exclusion criteria	1. Patients with intestinal perforation 2. Patients with bleeding tendency 3. Patients administering anti conaglant drugs 4. Patients with severe hepatic diseases 5. Patients with severe renal diseases 6. Patients with severe respiratory diseases 7. Patients with severe cardiac diseases 8. Pregnant or feeding women
Target sample size	20

Research contact person
Name of lead principal investigator	Atsuo Yamada
Organization	University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL	+81338155411
Email	yamada-a@umin.ac.jp

Public contact
Name of contact person	Atsuo Yamada
Organization	University of Tokyo
Division name	Department of Gastroenterology
Address	7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL	+81338155411
Homepage URL
Email	yamada-a@umin.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 05 Day
Anticipated trial start date	2013 Year 01 Month 07 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	2013 Year 01 Month 07 Day
Last modified on	2019 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011368