UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013887 |
|---|---|
| Receipt number | R000016200 |
| Scientific Title | A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones |
| Date of disclosure of the study information | 2014/05/08 |
| Last modified on | 2022/11/10 18:26:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones
Acronym
EST vs EPLBD for removal of bile ductal stones
Scientific Title
A prospective, randomized, controlled trial to compare the effectiveness of endoscopic sphincterotomy with endoscopic papillary large balloon dilation for removal of bile duct stones
Scientific Title:Acronym
EST vs EPLBD for removal of bile ductal stones
Region
| Japan |
Condition
Condition
bile duct stones, ductal stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of EST with EPLBD for removal of common bile duct stones
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1) total time for removal of bile duct stones
2) total sessions of ERCP
Key secondary outcomes
1)early and late complication rates
2)recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
EST group 30 cases
5/8/2014-5/7/2015
Interventions/Control_2
EPLBD group 30 cases
5/8/2014-5/7/2015
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A minor diameter of stone is larger than 10 mm.
2. Patients in whom papilla of Vater have not been treated endoscopically or surgically.
3. In emergent cases, patients in whom underwent EST or EBD within a week.
4. Patients in whom CT is performed before endoscopic procedures.
5. Patients in whom written informed consent is obtained.
Key exclusion criteria
1. Patients who underwent reconstruction of upper digestive tract(Bil II or RY)
2. Patients who underwent EST or EPBD previously.
3. Performance status is 4.
4. ASA physical status is more than 3.
5. Patients who undergo hemodaialysis.
6. Judged as inadequate for this study by the investigator.
7. Patients who become serious after first procedure.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyohito Tanaka |
Organization
Kyoto 2nd red cross hospital
Division name
Gastroenterology and hepatology
Zip code
Address
355-5 Haruobicho Kamannza Marutamachi Kamigyo ward Kyoto city
TEL
075-231-5171
seijin7705@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka Medical College
Division name
2nd department of internal medicine
Zip code
Address
2-7Daigakucho Takatsuki city Osaka
TEL
072-683-1221
Homepage URL
higuchi@poh.osaka-med.ac.jp
Sponsor or person
Institute
Kansai Endoscopic Device Selection (EDS) Working Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Endoscopic Device Selection (EDS) Working Group
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
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
| 2014 | Year | 05 | Month | 08 | 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
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016200
