UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015056
Receipt No. R000017509
Scientific Title The feasibility of diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy
Date of disclosure of the study information 2014/09/08
Last modified on 2015/09/02

* 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 The feasibility of diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy
Acronym The feasibility of diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy
Scientific Title The feasibility of diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy
Scientific Title:Acronym The feasibility of diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy
Region
Japan

Condition
Condition Hirschsprung disease, associated syndromes
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the feasibility of the diagnosis of the gastrointestinal nerve system with the confocal laser endomicroscopy in Hirschsprung disease, associated patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main outcome is to evaluate the distribution of gastrointestinal nerve system with the confocal microendoscopyin in Hirschsprung disease, associated patients.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Resected specimens of gastrointestinal tract with Hirschsprung disease, associated syndromes.
We will evaluate resected specimens of gastrointestinal tract with Meckel diverticulum and others, as a control group.
Key exclusion criteria 1)Necrotic gastrointestinal tract
2)Resected specimens which are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Sumiyama
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email kaz_sum@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakuni Kobayashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email masakuni@jikei.ac.jp

Sponsor
Institute Department of Endoscopy, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Department of Endoscopy, The Jikei University School of Medicine
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
2014 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: prospective observational study
Sampling: The resected specimens will be examined by confocal microendscopic images and histologically evaluated.

Management information
Registered date
2014 Year 09 Month 04 Day
Last modified on
2015 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.