UMIN-CTR Clinical Trial

Basic information
Public title	Distribution of enteric nerve system in the human gastrointestinal tract using optical biopsy technology, Raman spectroscopy
Acronym	Visualization of enteric nerve system in the gastrointestinal wall sing Raman spectroscopy
Scientific Title	Distribution of enteric nerve system in the human gastrointestinal tract using optical biopsy technology, Raman spectroscopy
Scientific Title:Acronym	Visualization of enteric nerve system in the gastrointestinal wall sing Raman spectroscopy
Region	Japan

Condition
Condition	Malignancy of gastrointestinal tract inflammatory bowel disease Hirschsprung disease
Classification by specialty	Gastrointestinal surgery Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The enteric nervous system is an autonomous nervous system essential for intestinal peristalsis, mucus secretion, and blood flow regulation, and consists of the intermuscular plexus (Auerbach's plexus) located between the longitudinal and circular muscles and the submucosal plexus ( Meissner's plexus) located in the submucosal tissue. If the detailed distribution of the enteric plexus in the human gastrointestinal tract is known, it may be possible to consider surgical techniques (extent of resected intestinal tract) based on this distribution. It may also be applicable to the diagnosis of diseases of abnormal gastrointestinal tract function caused by congenital absence of nerve plexus in the intestinal wall, such as Hirschsprung's disease. Recently, Raman spectroscopy, which analyzes molecular structure based on molecular vibration information when a substance is irradiated with light, has been applied to real-time in vivo monitoring, and is attracting attention as a new diagnostic method (optical biopsy) to replace intraoperative rapid pathological diagnosis in malignant tumors. The purpose of this study is to realize a novel optical diagnostic technique for non-invasive and real-time visualization of the nerve plexus in the intestinal wall by Raman spectroscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of enteric nerve system in the gastrointestinal wall using Raman spectroscopy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient undergoing gastrointestinal tract surgery
Key exclusion criteria	Patient undergoing emergency surgery
Target sample size	50

Research contact person
Name of lead principal investigator	1st name katsuhiro Middle name Last name Ogawa
Organization	Oita University Faculty of Medicine
Division name	Department of Gastroenterological and Pediatric Surgery
Zip code	879-5593
Address	1-1 Hasama, Yufu-city, Oita 879-5593, Japan
TEL	097-586-5843
Email	katsu-ogawa@oita-u.ac.jp

Public contact
Name of contact person	1st name Katsuhiro Middle name Last name Ogawa
Organization	Oita University Faculty of Medicine
Division name	Department of Gastroenterological and Pediatric Surgery
Zip code	879-5593
Address	1-1 Hasama, Yufu-city, Oita 879-5593, Japan
TEL	097-586-5843
Homepage URL
Email	katsu-ogawa@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

Funding Source
Organization	Oita University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
Organization	Oita university ethics committee
Address	1-1 Hasama, Yufu-city, Oita 879-5593, Japan
Tel	097-586-6380
Email	rinrikenkyu@oita-u.ac.jp

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	2022 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2023 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2023 Year 01 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Raman spectroscopic analysis is performed on resected organs of patients undergoing surgery at the Department. Specifically, organs to be resected for gastrointestinal cancer and inflammatory bowel disease are subjected to Raman spectroscopic analysis immediately prior to resection to identify the nerve plexus in the intestinal wall.

Management information
Registered date	2022 Year 12 Month 13 Day
Last modified on	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056690