UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008101
Receipt number R000009534
Scientific Title Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP)
Date of disclosure of the study information 2012/06/04
Last modified on 2012/06/04 19:11:36

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Basic information

Public title

Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP)

Acronym

Antispastic efficasy of l-menthol compared with scopolamine butylbromide for ERCP

Scientific Title

Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP)

Scientific Title:Acronym

Antispastic efficasy of l-menthol compared with scopolamine butylbromide 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 scopolamine butylbromide intravenous administration during endoscopic retrograde cholangiopancreatography.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


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


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

scopolamine butylbromide 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; prostatic hyperplasia; glaucoma; contraindication to scopolamine butylbromide; 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

Department 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

Department of gastroenterology and hepatology

Zip code


Address


TEL


Homepage URL


Email

y-gen6-4@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto prefectural Yosanoumi hospital

Institute

Department

Personal name



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

Open public recruiting

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

2012 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009534


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name