UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014231
Receipt No. R000016577
Scientific Title Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Date of disclosure of the study information 2014/06/30
Last modified on 2015/10/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Acronym Japan DBE Study
Scientific Title Japan multi-study:Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Scientific Title:Acronym Japan DBE Study
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of endoscopic balloon dialation to stricture using double-balloon endoscope with forceps channel diameter 3.2mm
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Propriety for endoscopic balloon dilation for small bowel strictures
Key secondary outcomes 1.Difficulty of balloon catheter insertion.
2.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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients.
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 years old
2.causing obstructive symptoms
3.more than 5cm in length of stricture
4.There are no following conditions in strictures.
1)without fistula or abssess
2)without deep ulcer
3)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
1st name
Middle name
Last name Toshiyuki Matsui
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino Fukuoka
TEL 092-921-1011
Email matsui@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikushino Fukuoka
TEL 092-921-1011
Homepage URL
Email fuhirai@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

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

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 自治医科大学(栃木県)、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)、岩手医科大学(岩手県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 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 No longer recruiting
Date of protocol fixation
2013 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 04 Month 30 Day
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 11 Day
Last modified on
2015 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.