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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017733
Receipt No. 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

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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
Email 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
Email shindoh@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi Hospital
First Department of Internal Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020537

Research Plan
Registered date File name
2021/01/11 1314オフセットバルーン研究計画書 修正後.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/01/11 TG_data file.xlsx


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