UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020012 |
|---|---|
| Receipt number | R000023102 |
| Scientific Title | Efficacy of L-menthol in endoscopic diagnosis for gastric neoplasms |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2017/09/01 19:11:04 |
* 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
Efficacy of L-menthol in endoscopic diagnosis for gastric neoplasms
Acronym
L-menthol method for gastric neoplasms
Scientific Title
Efficacy of L-menthol in endoscopic diagnosis for gastric neoplasms
Scientific Title:Acronym
L-menthol method for gastric neoplasms
Region
| Japan |
Condition
Condition
gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of L-menthol in endoscopic diagnosis for gastric neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation objectively the effectiveness of L-menthol for identifying gastric neoplasms and determining neoplasm margins. Using "Color difference", digitize color difference, and bigger numerical data is more clear determining neoplasm margins.
Calculate "Color difference" of each L-menthol spreyed neoplasm and not, and compare two values. Same as do for NBI.
Key secondary outcomes
Evaluation that whether "Color difference" is had an effect by morphological type, tissue type, location, atrophy of surrounding gastric mucosa and Helicobacter pylori inffection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Biopsy of gastric neoplasms and surrounding non-tumorous mucosa
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Diameter of gastric neoplasm is smaller than 30mm, and depth of tumor invasion is from mucosa to submucosa
2.Patients who agree the content of this study
Key exclusion criteria
1.The past medical history of gastric operation
2.Allergy of L-menthol
3.Patients who could not agree the content of this study
4.Patients that researchers admit inadequate for candidates
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hikichi Takuto |
Organization
Fukushima Medical University Hospital
Division name
Depertment of Endoscopy
Zip code
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1586
takuto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kikuchi Hitomi |
Organization
Fukushima Medical University School of medicine
Division name
Depertment of Gastroenterology and Rheumatology
Zip code
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1202
Homepage URL
hitomi25@fmu.ac.jp
Sponsor or person
Institute
Depertment of Gastroenterology and Rheumatology, Fukushima Medical University School of medicine and Depertment of Endoscopy, Fukushima Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023102
