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

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 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


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

Value
https://center6.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