UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022383 |
|---|---|
| Receipt number | R000025786 |
| Scientific Title | Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2016/05/20 14:04:39 |
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Basic information
Public title
Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens
Acronym
Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens
Scientific Title
Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens
Scientific Title:Acronym
Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens
Region
| Japan |
Condition
Condition
gastrointestinal motility disorder
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of visualization of nerve plexus in patients with gastrointestinal motility disorder by using confocal laser endomicroscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution and configuration of digestive nerve plexus in patients with diabetic gastrointestinal motility disorder.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Control group: Non-DM patients without gastrointestinal motiluty disorder.
2.Non-DM gastrointestinal motility disorder group: patients who have symptoms of gastrointestinal motility disorder (> 6months).
3.DM group:
I: Patients who had been diagnosed as diabetes mellitus (type 1 or type 2).
II: HbA1c >6.5%
Key exclusion criteria
1.Patients who disagree with contents of this clinical research.
2.The case of emergency surgery.
3.Inappropriate cases for this clinical research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kamba |
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
kanba@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kamba |
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
kanba@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei university school of medicine, department of Endoscopy
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
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
| 2016 | Year | 05 | Month | 20 | 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
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We perform confocal laser endomicroscopy to observe digestive nerve plexus.
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025786
