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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004890
Receipt No. R000005824
Scientific Title Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Date of disclosure of the study information 2011/01/17
Last modified on 2019/01/23

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Basic information
Public title Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Acronym Capsule endoscopy for the assessment of postsurgical lesions of Crohn's disease
Scientific Title Capsule endoscopy for the assessment of remaining small bowel lesions at surgery and postsurgical recurrence in patients with Crohn's disease
Scientific Title:Acronym Capsule endoscopy for the assessment of postsurgical lesions of Crohn's disease
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the remaining small bowel lesions at the early postoperative period of Crohn's disease using capsule endoscopy. In addition, the diagnostic advantage of chromo-capsule endoscopy is also investigated by a randomized crossover study.
Basic objectives2 Others
Basic objectives -Others To investigate the postsurgical recurrence, patients are reexamined at 6 months after surgery by capsule endoscopy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.The degree of remaining small bowel lesions at the early postoperative period of Crohn's disease using capsule endoscopy
2.The degree of postsurgical recurrence at 6 months after surgery of Crohn's disease using capsule endoscopy
Key secondary outcomes The diagnostic advantage of chromo-capsule endoscopy

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 chromo-capsule endoscopy followed by conventional capsule endoscopy
Interventions/Control_2 conventional endoscopy first, followed by chromo-capsule endoscopy
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.The patients with Crohn's disease who underwent intestinal resection of all macroscopically diseased tissue
2.Candidate has to agree to be enrolled for the study under sufficient written informed consent.
Key exclusion criteria 1.Over a month of postoperative period
2.Patients with intestinal stenosis
3.Petients with severe intestinal adhesion
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Matsumoto
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6662
Email hidan@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Hida
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6662
Homepage URL
Email hidan@hyo-med.ac.jp

Sponsor
Institute Department of lower gastroenterology, Hyogo College of Medicine
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)

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

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 17 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 Open public recruiting
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2014 Year 07 Month 30 Day
Date analysis concluded
2014 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 17 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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