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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024153
Receipt No. R000027800
Scientific Title Efficacy of physician-controlled wire-guided cannulation for bile duct using a novel shincterotome.
Date of disclosure of the study information 2016/10/03
Last modified on 2018/02/25

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Basic information
Public title Efficacy of physician-controlled wire-guided cannulation for bile duct using a novel shincterotome.
Acronym Efficacy of physician-controlled wire-guided cannulation using a novel shincterotome.
Scientific Title Efficacy of physician-controlled wire-guided cannulation for bile duct using a novel shincterotome.
Scientific Title:Acronym Efficacy of physician-controlled wire-guided cannulation using a novel shincterotome.
Region
Japan

Condition
Condition common bile duct stones, obstructive jaundice, acute cholangitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of wire-guided cannulation for bile duct using a novel sphincterotome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of bile duct cannulation success within 10 minutes
Key secondary outcomes

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
Device,equipment Maneuver
Interventions/Control_1 Bile duct cannulation will be attempted by wire-guided cannulation using a novel sphincterotome
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 are eligible for this Study if they meet all the criteria shown below.
Patients who are over 20 years old
Patients who have common bile duct stone or cholangitis or obstructive jaundice
Patients for whom ERCP and EST are planned
Patients who have native papilla
Key exclusion criteria Patients are to be excluded from this Study if they conflict with any of the criteria shown below
Patients who have ampullary tumor
Patients who have tumor invasion in the papilla
Patients with surgically altered gastrointestinal or pancreatobiliary anatomy
Patients who score 4 in Performance Status
Patients with serious complication on other organ(s): Higher than 3 with ASA category (dialyzed patients are also excluded)
Patients judged to have less than 3 months of life expectancy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Uno
Organization Kyoto Second Red Cross Hospital
Division name Department of Gastroenterology
Zip code
Address 355-5 Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, Japan
TEL 075-231-5171
Email unok@kyoto2.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Mandai
Organization Kyoto Second Red Cross Hospital
Division name Department of Gastroenterology
Zip code
Address 355-5 Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, Japan
TEL 075-231-5171
Homepage URL
Email mndkchr@gmail.com

Sponsor
Institute Department of Gastroenterology, Kyoto Second Red Cross Hospital
Institute
Department

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
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
2016 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.gastrores.org/index.php/Gastrores/article/view/974
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 Completed
Date of protocol fixation
2016 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 18 Day
Last follow-up date
2017 Year 05 Month 13 Day
Date of closure to data entry
2017 Year 05 Month 13 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2018 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027800

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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