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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008100
Receipt No. R000009532
Scientific Title Antiperistaltic effect of l-menthol spray on the duodenal mucosa compared with glucagon intravenous administration for endoscopic retrograde cholangiopancreatography (ERCP)
Date of disclosure of the study information 2012/06/04
Last modified on 2013/12/04

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Basic information
Public title Antiperistaltic effect of l-menthol spray on the duodenal mucosa compared with glucagon intravenous administration for endoscopic retrograde cholangiopancreatography (ERCP)
Acronym Antiperistaltic effect of l-menthol compared with glucagon for ERCP
Scientific Title Antiperistaltic effect of l-menthol spray on the duodenal mucosa compared with glucagon intravenous administration for endoscopic retrograde cholangiopancreatography (ERCP)
Scientific Title:Acronym Antiperistaltic effect of l-menthol compared with glucagon for ERCP
Region
Japan

Condition
Condition biliary tract disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the duodenal antiperistaltic effect of 1.6% l-menthol spray on the duodenal mucosa compared with that of glucagon intravenous administration during endoscopic retrograde cholangiopancreatography.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome was the rate of peristalsis suppression of duodenum after treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 l-mentol spray on the duodenal mucosa during ERCP
Interventions/Control_2 glucagon intravenous administration during ERCP
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 The study group included patients who required cholangiography.
Patients who are planned ERCP. Patients or their family who fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria age 20 years younger; severe heart disease; severe lung disease; pregnant and breast-feeding women or women suspected of being pregnant; women are not willing to avoid pregnancy during the duration of study; acute pancreatitis; chronic pancreatitis with an acute exacerbation; post gastrectomy; biliary cannulation using with Rendezvous method; contrast medium allergy; or refusal to provide informed consent.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Tokita
Organization Kyoto prefectural Yosanoumi hospital
Division name Depertment of gastroenterology and hepatology
Zip code
Address 481 Otokoyama Yosano-cho, 629-2261 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Gen
Organization Kyoto prefectural Yosanoumi hospital
Division name Depertment of gastroenterology and hepatology
Zip code
Address
TEL
Homepage URL
Email y-gen6-4@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural Yosanoumi hospital
Institute
Department

Funding Source
Organization Kyoto prefectural Yosanoumi hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 04 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 Terminated
Date of protocol fixation
2012 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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
2012 Year 06 Month 04 Day
Last modified on
2013 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009532

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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