UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective pilot study of the usefulness of l-menthol as antispasmodic drug during ERCP.
Title of the study (Brief title)	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	Masatoshi Mabuchi
Organization	Mizonokuchi Hospital Teikyo University School of Medicine
Division name	Department of Gastroenterology
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	Masatoshi Mabuchi
Organization	Mizonokuchi Hospital Teikyo University School of Medicine
Division name	Department of Gastroenterology
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

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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