UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049767 |
|---|---|
| Receipt number | R000056690 |
| Scientific Title | Distribution of enteric nerve system in the human gastrointestinal tract using optical biopsy technology, Raman spectroscopy |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2022/12/13 17:36:53 |
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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
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
| 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
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
katsu-ogawa@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita university ethics committee
Address
1-1 Hasama, Yufu-city, Oita 879-5593, Japan
Tel
097-586-6380
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056690
