UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017733 |
|---|---|
| Receipt number | R000020537 |
| Scientific Title | A prospective study of endoscopic biliary stone extraction using offset balloon catheter |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/28 22:04:59 |
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Basic information
Public title
A prospective study of endoscopic biliary stone extraction using offset balloon catheter
Acronym
Offset balloon vs conventional balloon in biliary stone extraction
Scientific Title
A prospective study of endoscopic biliary stone extraction using offset balloon catheter
Scientific Title:Acronym
Offset balloon vs conventional balloon in biliary stone extraction
Region
| Japan |
Condition
Condition
Common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the success rate of endoscopic clearance of biliary stone using an offset balloon and a conventional balloon catheter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of complete stone removal by balloon catheter only
Key secondary outcomes
Time to biliary stone extraction using balloon catheter
Incidence rate and severity of complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
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 |
Interventions/Control_1
A group undergo biliary stone extraction using an offset balloon catheter
Interventions/Control_2
A group undergo biliary stone extraction using a conventional balloon catheter
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with common bile duct stone confirmed by cholangiogram
Key exclusion criteria
1) ASA physical status class of >=3
2) Billroth II or Roux-en-Y reconstruction
3) Bile duct diameter>=20mm
4) Malignant biliary stenosis
5) Large balloon dilation performed
6) Patients with bleeding tendency
7) Acute pancreatitis
8) Severe renal disease, respiratory disease, cardiac disease
9) Impossible to decision making
10) In case that doctors judge inappropriate for the entry
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Enomoto |
Organization
University of Yamanashi Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, JAPAN
TEL
055-273-9584
enomoto@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Shindo |
Organization
University of Yamanashi Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, JAPAN
TEL
055-273-9584
Homepage URL
shindoh@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi Hospital
First Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kofu Municipal Hospital
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
山梨大学医学部附属病院（山梨県）、市立甲府病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020537
