UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024153 |
|---|---|
| Receipt number | 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 15:27:31 |
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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
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
mndkchr@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Kyoto Second Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027800
