UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Visualization of digestive nerve plexus by using confocal laser endomicroscopy on surgically resected specimens
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shunsuke Kamba
Organization	The Jikei university school of medicine
Division name	Department of endoscopy
Address	3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL	03-3433-1111
Email	kanba@jikei.ac.jp

Public contact
Name of contact person	Shunsuke Kamba
Organization	The Jikei university school of medicine
Division name	Department of endoscopy
Address	3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL	03-3433-1111
Homepage URL
Email	kanba@jikei.ac.jp

Sponsor
Institute	The Jikei university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 06 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025786