UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001684 |
|---|---|
| Receipt number | R000002012 |
| Scientific Title | A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion |
| Date of disclosure of the study information | 2009/02/02 |
| Last modified on | 2010/11/24 22:40:02 |
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Basic information
Public title
A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Acronym
RCT of DBE vs. SBE for difficult colonoscope insertion
Scientific Title
A Randomized Controlled Trial of the Usefulness of Double Balloon Enteroscopy and Single Balloon Enteroscopy for Difficult Cases of Colonoscope Insertion
Scientific Title:Acronym
RCT of DBE vs. SBE for difficult colonoscope insertion
Region
| Japan |
Condition
Condition
Colon disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate efficacy and safety on balloon enteroscopy using double balloon enteroscopy or single balloon enteroscopy for completion of colon examination after incomplete colonoscopy with conventional colonoscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total colonoscopy rate
Examination time
Manual compression rate
Changing position rate
X-ray exposure time
Diagnostic yield
Key secondary outcomes
Patient's pain on examination,
Operability of endoscopy
Complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Double balloon enteroscopy
Interventions/Control_2
Single balloon enteroscopy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had incomplete colonoscopy with a conventional colonoscope
Key exclusion criteria
Patients with known fulminant colitis or colorectal malignancy
Incomplete colonoscopy because of fixed stenosis or poor bowel preparation
Severe hepatic dysfunction or severe renal dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamaji |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamaji |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku,Tokyo, Japan
TEL
03-3815-5411
Homepage URL
yamaji-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 02 | Day |
Last modified on
| 2010 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002012
