UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008445
Receipt number R000009934
Scientific Title A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire.
Date of disclosure of the study information 2012/07/20
Last modified on 2014/01/16 09:07:46

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Basic information

Public title

A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire.

Acronym

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

Scientific Title

A prospective randomized controlled trial of wire guided deep biluary cannulation using straight and angled tip guidewire.

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Biliary diseases

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparsion of deep cannulation rete between using straight and angled tip guidewire.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate of biliary deep cannulation

Key secondary outcomes

Complicaion rate
Total proceedure time of ERCP


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Biliary cannulation using straight tip guidewire

Interventions/Control_2

Biliary cannulation using angled 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. Diagnostic or therapeutic ERCP for biliary disease
2. Naiive papilla
3. Patients who understand and are willing to give a written informed consent about participation

Key exclusion criteria

1. Patients with severely impaired hematological, hepatic, renal, and heart function.
2. Patients with performance status Patients with bleeding tendency (Plt < 50000, PT INR >= 1.5).
3. Patients with consciousness disorder (>=Japan Coma Scale I-1).
4. Patients with pancreatic disorder which need ERP.
5. Patients with tumor of amppulla of the Vater.
6. patients with surgically-altered anatomy of upper gastro intestinal tract excluding Billroth I method.
7. Patients considered ineligible for this study.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuyoshi Hayashi

Organization

Sapporo Medical University

Division name

Fourth Department of Internal Medicine

Zip code


Address

South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.

TEL

011-611-2111

Email

thayashi69@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Hayashi

Organization

Sapporo Medical University

Division name

Fourth Department of Internal Medicine

Zip code


Address

South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.

TEL

011-611-2111

Homepage URL


Email

thayashi69@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University, Fourth Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University, Fourth Department of Internal Medicine

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 07 Month 20 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

Enrolling by invitation

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 20 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 07 Month 16 Day

Last modified on

2014 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name