UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031261 |
|---|---|
| Receipt number | R000035643 |
| Scientific Title | Comparison between balloon assisted enteroscopy and MR enterography for lesion of Crohn's disease patients: a prospective multicenter randomized controlled trial |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/02/20 01:48:08 |
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Basic information
Public title
Comparison between balloon assisted enteroscopy and MR enterography for lesion of Crohn's disease patients: a prospective multicenter randomized controlled trial
Acronym
Progress Study 2
Scientific Title
Comparison between balloon assisted enteroscopy and MR enterography for lesion of Crohn's disease patients: a prospective multicenter randomized controlled trial
Scientific Title:Acronym
Progress Study 2
Region
| Japan |
Condition
Condition
Crohn's disease patients with small bowel lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacies for the detection of lesions in patients with Crohn's disease by comparison with "MR enterography and conventional ileocolonoscopy" and "MR enterography and retrograde balloon assisted enterography".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of mucosal lesion in the small bowel in patients with Crohn's disease among "MR enterography and conventional ileocolonoscopy" and "MR enterography and retrograde balloon assisted enterography"
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
MR enterography (MRE) and retrograde balloon assisted enteroscopy
Interventions/Control_2
MR enterography (MRE) and conventional ileocolonoscopy
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Crohn's disease who have small bowel lesion that was diagnosed imaging modality.
Key exclusion criteria
1) Patients who are less than 15 years old.
2) Patients who have past history of surgery for large bowel or small bowel.
3) Patients who have stoma.
4) Patients who are impossible to insert the middle of ileum by retrograde balloon assisted enteroscopy.
5) Patients who have severe stricture that was impossible to be passed by endoscopy in the large bowel or anus.
6) Claustrophobic patient.
7) Patients with a pacemaker.
8) Patients who are implanted metallic material that is contraindication for magnetic resonance imaging.
9) Patients who are tattooed.
10) Patients who are in pregnancy or have possibility for becoming pregnant.
11) Patients who are hypersensitivity for gadolinium-based contrast agent.
12) Patients who are bronchial asthma.
13) Patients who are severe renal failure.
14) Patients who have obstructive symptom.
15) Patients who are estimated as unsuitableness by physician.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Hyogo College of Medicine
Division name
Department of Intestinal Inflammation Research
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6663
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Hyogo College of Medicine
Division name
Department of Intestinal Inflammation Research
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6663
Homepage URL
kenjiw1779@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2851
Org. issuing International ID_1
The ethical committee of Hyogo College of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035643
