UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009291
Receipt number R000010734
Scientific Title A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Date of disclosure of the study information 2012/11/09
Last modified on 2013/12/10 20:22:58

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Basic information

Public title

A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.

Acronym

A prospective randomized controlled trial of WGC using J and straight tip guidewire.

Scientific Title

A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.

Scientific Title:Acronym

A prospective randomized controlled trial of WGC using J and straight tip guidewire.

Region

Japan


Condition

Condition

Biliary and pancreatic diseases requiring biliary tract catheter insertion.

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the successful insertion rate between J and straight tip guidewire for WGC.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Successful insertion rate

Key secondary outcomes

Complication rate
Time of deep cannulation
Cost


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

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Biliary cannulation in WGC using J tip guidewire

Interventions/Control_2

Biliary cannulation in WGC using straight tip guidewire

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)Patients require biluary tract catheter insertion, with no history of duodenal papilla treatment.
(2)Patients who understand and are willing to give a written informed consent about participation.

Key exclusion criteria

(1)Patients with gastrectomy by Billroth II and Roux-en-Y renstruction
(2)Patients in Perfomance status 4
(3)Patients require ERP
(4)Patients with severe complication inother organs
(5)Patients judged by principal investigator to be inadequate as subjects

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Watanabe Seitaro

Organization

Yokohama City University Hospital

Division name

Gastroenterology Division

Zip code


Address

3-9 Fukuura, Kanazawa-ku Yokohama, Kanagawa

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama City University Hospital

Division name

Gastroenterology Division

Zip code


Address

3-9 Fukuura, Kanazawa-ku Yokohama, Kanagawa

TEL


Homepage URL


Email



Sponsor or person

Institute

Yokohama City University Hospital, Gastroenterology Division

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


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



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 09 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

Completed

Date of protocol fixation

2012 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 22 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

2012 Year 11 Month 08 Day

Last modified on

2013 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010734


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name