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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029125
Receipt No. R000028192
Scientific Title A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Date of disclosure of the study information 2017/09/26
Last modified on 2017/09/13

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Basic information
Public title A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Acronym The usefulness of l-menthol in ERCP
Scientific Title A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Scientific Title:Acronym The usefulness of l-menthol in ERCP
Region
Japan

Condition
Condition Bile duct stone
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the validity and safety of l-menthol as antispasmodic drug in ERCP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of complete procedure planned without additional antispasmodic drugs
Key secondary outcomes Time to deep cannulation into common bile duct or pancreatic duct
total procedure time
Complications related to the procedures

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 l-menthol
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 Patients who performed diagnostic ERCP for pancreatic or biliary diseases.
Key exclusion criteria 1) Patients with previous gastrectomy.
2) Patients with allergic for l-menthol.
3) Patients with severe complications of other organs.
4) Pregnant patients or patients who were suspected pregnancy.
5) Patients whose informed consent could not be obtained.
6) In case that doctors judged inappropriate for the entry.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Mabuchi
Organization Mizonokuchi Hospital Teikyo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL 044-844-3333
Email masatoshi.mabuchi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Mabuchi
Organization Mizonokuchi Hospital Teikyo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL 044-844-3333
Homepage URL
Email masatoshi.mabuchi@gmail.com

Sponsor
Institute Teikyo University Mizonokuchi Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 帝京大学医学部附属溝口病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 26 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 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
2017 Year 09 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028192

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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