UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020731 |
|---|---|
| Receipt number | R000023918 |
| Scientific Title | Randomized controlled trial of prior minimal endoscopic spincteroplasty /EST + endoscopic ballon sphincteroplasty /EBS and EST in a choledocholith treatment |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/01/29 13:19:57 |
* 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
Randomized controlled trial of prior minimal endoscopic spincteroplasty /EST
+ endoscopic ballon sphincteroplasty /EBS and EST in a choledocholith treatment
Acronym
Randomized controlled trial of prior minimal EST + EBS and EST in a choledocholith treatment
Scientific Title
Randomized controlled trial of prior minimal endoscopic spincteroplasty /EST
+ endoscopic ballon sphincteroplasty /EBS and EST in a choledocholith treatment
Scientific Title:Acronym
Randomized controlled trial of prior minimal EST + EBS and EST in a choledocholith treatment
Region
| Japan |
Condition
Condition
choledocholith
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the efficacy of prior minimal EST+ EBS in a choledocholith treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of complication
after the procedure in 7days
Key secondary outcomes
The stone clearance rate, and the number of ERCPs required for complete stone clearance.
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
| Maneuver |
Interventions/Control_1
minimal EST+EBS group
Interventions/Control_2
EST group
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
1,the presence of choledocholith < 8mm in
CT,MRI,US,EUS within a month
2ECOS PS is 0 or 1
3Criteria blood test
Neutrophils < 1500/ml,Plt<80000,Hb>9.0,
Cre<1.5mg/dl,AST/ALT<92/107,T-Bil<2mg/dL,
Alb2.8g/dL,PT-INR<1.5
4,the patient who is expected to live more than three month
Key exclusion criteria
1,a history of EST or EBS
2,a history of Billroth 2 or Roux-en-Yanatomy
3,pancreatobiliary malignancy
4,choledochoduodenalfistula , concurrent hepatolithiasis
5,the patient who has a heart disease
.a history of congested heart failure, cardiac infarction
.a history of serious arrhythmia, hypertention
.a history of coronary disease
6,the patient who has a mental disease
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jin Kan Sai |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111(70227)
ivo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Kanazawa |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111(70226)
Homepage URL
rkanaza@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Hospital
Department of Gastroenterology
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
| 2016 | Year | 03 | Month | 01 | 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
| 2015 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023918
