UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan multi-center study: Efficacy of additional injection of contrast medium during endoscopic balloon dilation by using duble-balloon endoscope with a 3.2mm accessory channel
Title of the study (Brief title)	Japan DBEBD AICM Study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of additional injection of contrast medium during endoscopic balloon dilation by using duble-balloon endoscope with a 3.2mm accessory channel
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Visibility of stricture by fluoroscopy, before or while balloon dialation when performing endoscopic balloon dilation in three different diameter after endoscopic enteroclysis
Key secondary outcomes	1. Feasibiltiy of additional injection of contrast medium while inserting balloon catheter into accessory channel. 2. Visibility of stricture by fluoroscopy after additional injection of contrast medium 3. Check of Adverse event and it's Contents.

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	addition of contrast medium during endoscopic balloon dilation
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. More than 20 years old and less than 75 yesra old 2. Small intestinal stricture 3. More than 5cm in length of stricture 4. There are no following conditions in strictures. i) without fistula or abscess ii) without deep ulcer iii) without severe curvature
Key exclusion criteria	1. acute abdomen 2. severe inflammation 3. pregnant woman 4. poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor 5. ongoing anti coagulation therapy or anti platelet therapy 6. intolerance of polyethylene glycol only for transanal approach 7. patient who experienced entry of this study 8. patient who is judged to be unsuitable for this clinical trial
Target sample size	50

Research contact person
Name of lead principal investigator	Hironori Yamamoto
Organization	Jichi Medical University
Division name	Department of medicine, Division of gastroeterology
Address	Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
TEL	+81-285-58-7348
Email	yamamoto@jichi.ac.jp

Public contact
Name of contact person	Tomonori Yano
Organization	Jichi Medical University
Division name	Department of medicine, Division of gastroeterology
Address	Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
TEL	+81-285-58-7348
Homepage URL
Email	tomonori@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	FUJIILM Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	日本医科大学（東京都）、名古屋大学（愛知県）、広島大学（広島県）、福岡大学筑紫病院（福岡県）、九州大学（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 06 Day
Anticipated trial start date	2014 Year 08 Month 25 Day
Last follow-up date	2015 Year 04 Month 30 Day
Date of closure to data entry	2015 Year 06 Month 30 Day
Date trial data considered complete	2015 Year 06 Month 30 Day
Date analysis concluded	2017 Year 07 Month 31 Day

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

Management information
Registered date	2014 Year 08 Month 25 Day
Last modified on	2017 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017243