UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043998
Receipt number R000049517
Scientific Title Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture
Date of disclosure of the study information 2021/04/21
Last modified on 2021/04/21 15:25:55

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Basic information

Public title

Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture

Acronym

Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture

Scientific Title

Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture

Scientific Title:Acronym

Multicenter prospective study on the usefulness of 0.025 inch guide wire in ERCP-related treatment for distal malignant biliary stricture

Region

Japan


Condition

Condition

Distal malignant biliary stenosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In this study, we investigated the completion rate of the procedure when using one 0.025 inch guidewire, and found the usefulness of one 0.025 inch guidewire when treating distal malignant biliary stricture without prior endoscopic treatment. The purpose is to clarify.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

0.025inch guidewire Procedure completion rate with one

Key secondary outcomes

Incidence of complications, treatment time, incidence of product defects, replacement of surgeons


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Patients undergoing endoscopic bile duct stent placement under 0.025 inch guidewire for distal malignant biliary stricture without prior endoscopic treatment

Key exclusion criteria

Patients with a history of endoscopic treatment

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Nakashima

Organization

Kawasaki Medical School

Division name

Biliary and pancreatic intervention studies

Zip code

701-0192

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

TEL

086-462-1111

Email

ercpnakazi@gmail.com


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Nakashima

Organization

Kawasaki Medical School

Division name

Biliary and pancreatic intervention studies

Zip code

701-0192

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

TEL

086-462-1111

Homepage URL


Email

ercpnakazi@gmail.com


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawasaki Medical School / Hospital Ethics Committee

Address

577 Matsushima, Kurashiki City, Okayama Prefecture

Tel

086-464-1076

Email

kmsrec@med.kawasaki-m.ac.jp


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

川崎医科大学附属病院(岡山県)、倉敷中央病院(岡山県)、岡山済生会病院(岡山県)、岡山赤十字病院(岡山県)、岡山大学病院(岡山県)、岡山ろうさい病院(岡山県)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 21 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

2020 Year 05 Month 01 Day

Date of IRB

2020 Year 07 Month 03 Day

Anticipated trial start date

2020 Year 07 Month 03 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Endoscopic retrograde pancreatobiliary angiography (ERCP) was performed for patients with distal malignant biliary stricture such as pancreatic head cancer, distal bile duct cancer, and papillary cancer with obstructive jaundice, and a bile duct stent was placed. It is necessary to secure a bile outflow route. Most of the guidewires (hereinafter referred to as GW) used during ERCP were 0.035 inch, and 0.025 inch GW was limited to cases with strong stenosis. However, in recent years, the development of 0.025 inch guidewire (GW) has progressed, and the rotation and resistance are comparable to 0.035 inch, and it is easy to pass through the stenosis site and replace the treatment tool, so 0.025 inch GW is used. The number of facilities that make it the first choice has increased. If the procedure can be completed with one 0.025 inch GW, it will be beneficial in terms of medical costs. The purpose of this study is to clarify the usefulness of a single 0.025 inch GW during treatment for distal malignant biliary stricture without prior endoscopic treatment.


Management information

Registered date

2021 Year 04 Month 21 Day

Last modified on

2021 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name